FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients in this study had no exposure to inhaled tobramycin for at least 4 months prior to study start.
Danish: Patienterne i dette studie havde ikke været eksponeret for inhaleret tobramycin i mindst 4 måneder forud for studiets start.
English: • It is not harmful if these pieces are swallowed or inhaled.
Danish: • Det er ikke farligt at sluge eller inhalere disse stykker.
English: No other inhaler may be used.
Danish: Ingen anden inhalator må anvendes.
English: These may still happen while taking TOBI Podhaler, but should not be any more frequent or seem worse than before.
Danish: De kan stadig forekomme, mens du tager TOBI Podhaler, men de må ikke være hyppigere eller værre end før.
English: It is not known whether inhaling this medicine when you are pregnant causes side effects.
Danish: Man ved ikke, om inhalation af dette lægemiddel under graviditet har bivirkninger.
English: Wash and fully dry your hands.
Danish: Vask hænderne, og tør dem fuldstændigt.
English: In the open label extensions, each additional 6 months of treatment resulted in incremental increases similar in magnitude to that observed in the 6 months of placebo-controlled studies.
Danish: I de åbne forlængelsesstudier resulterede hver yderligere 6 måneders behandling i øgede stigninger af samme størrelsesorden som der blev observeret i de 6 måneder af de placebo-kontrollerede studie.
English: • 1 inhaler (the Podhaler device) and its storage case.
Danish: • 1 inhalator (Podhaler) og dens opbevaringshylster.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: Officiel vejledning angående hensigtsmæssig brug af antibakterielle lægemidler bør tages i betragtning.
English: • Coughing up blood (very common)
Danish: • Ophostning af blod (meget almindelig)
English: In the active-controlled study, audiology testing was performed in selected centres accounting for about a quarter of the study population.
Danish: I det aktiv-kontrollerede studie blev der blev foretaget audiologisk undersøgelse i udvalgte centre svarende til omkring en fjerdedel af forsøgspopulationen.
English: Resistance to tobramycin involves different mechanisms.
Danish: Resistens over for tobramycin involverer forskellige mekanismer.
English: Severely maternally toxic doses to female rabbits (i.e. nephrotoxicity) lead to spontaneous abortions and death.
Danish: Alvorlige maternelle toksiske doser hos kaniner (dvs. nefrotoksicitet) medfører spontane aborter og død.
English: People with cystic fibrosis have many symptoms of the disease.
Danish: Patienter med cystisk fibrose har mange symptomer på sygdommen.
English: Lift here to open.
Danish: Åbnes her.
English: Safety and efficacy have not been studied in patients with forced expiratory volume in 1 second (FEV1) <25% or >75% predicted, or patients colonised with Burkholderia cepacia.
Danish: Sikkerhed og effekt er ikke undersøgt hos patienter med et forventet forceret ekspirationsvolumen i 1. sekund (FEV1) på <25 % eller >75 % eller patienter koloniseret med Burkholderia cepacia.
English: • hearing problems (including noises in the ears and dizziness)
Danish: • høreproblemer (herunder støj i ørerne og svimmelhed)
English: If the capsule is pierced but still contains some powder:
Danish: Hvis kapslen er perforeret, men stadig indeholder noget pulver:
English: TOBI Podhaler should not be given to children less than 6 years old.
Danish: TOBI Podhaler må ikke gives til børn under 6 år.
English: No recommendation for or against dose adjustment can be made for patients after organ transplantation.
Danish: Der kan ikke gives nogen anbefaling for eller imod dosisjustering for organtransplanterede patienter.
English: It is important that you keep using the product twice each day during your 28 days on treatment and that you keep to the 28-day on, 28-day off cycle.
Danish: Det er vigtigt, at du fortsætter med at bruge produktet to gange daglig i den 28 dages behandlingsperiode, og at du overholder skiftet mellem 28 dage med behandling og 28 dage uden.
English: • muscle weakness that lasts or becomes worse over time, a symptom mostly related to conditions such as myasthenia or Parkinson's disease.
Danish: • muskelsvaghed, der varer ved eller bliver værre med tiden, et symptom, der som oftest er relateret til sygdomme som myasteni eller Parkinsons sygdom.
English: The main resistance mechanisms are drug efflux and drug inactivation by modifying enzymes.
Danish: De vigtigste resistensmekanismer er efflux af lægemidlet og inaktivering af lægemidlet ved modificerende enzymer.
English: It is one of the most damaging bacteria for people with cystic fibrosis.
Danish: Den er en af de mest skadelige bakterier for patienter med cystisk fibrose.
English: It acts primarily by disrupting protein synthesis leading to altered cell membrane permeability, progressive disruption of the cell envelope and eventual cell death.
Danish: Det virker primært ved at forstyrre proteinsyntese, hvilket medfører ændret cellemembranpermeabilitet, fremadskridende nedbrydning af cellemembranen og til slut celledød.
English: Although the magnitude of improvements in lung function was smaller in this study, this is explained by the previous exposure of this patient population to treatment with inhaled tobramycin.
Danish: Selvom omfanget af forbedringer i lungefunktionen var mindre i dette studie, kan dette forklares ved denne patientpopulations tidligere behandling med inhaleret tobramycin.
English: • Do not use this medicine after the expiry date which is stated on the box or capsule card.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på pakningen eller kapselkortet efter EXP.
English: It is bactericidal at concentrations equal to or slightly greater than inhibitory concentrations.
Danish: Det er baktericidt i koncentrationer, der svarer til eller er en smule større end hæmmende koncentrationer.
English: FEV1 should be measured before and after inhalation of TOBI Podhaler.
Danish: FEV1 skal måles før og efter inhalation af TOBI Podhaler.
English: Your doctor will supervise your first dose of TOBI Podhaler and check your lung function before and after dosing.
Danish: Din læge vil overvåge din første dosis TOBI Podhaler og kontrollere din lungefunktion før og efter dosis.
English: Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
Danish: Inden for hver systemorganklasse er bivirkningerne opstillet efter hyppighed med de hyppigste bivirkninger først.
English: The maximum tolerated daily dose of TOBI Podhaler has not been established.
Danish: Den maksimalt tolererede daglige dosis af TOBI Podhaler er ikke fastslået.
English: Otherwise, the patient should wait for the next dose and not inhale more capsules to make up for the missed dose.
Danish: Ellers skal patienten vente til næste dosis og ikke inhalere flere kapsler for at indhente den glemte dosis.
English: Finger prick blood sampling is not recommended due to the risk of contamination of the sample.
Danish: Fingerprik-blodprøvetagning anbefales ikke på grund af risikoen for forurening af prøven.
English: This means that TOBI Podhaler may not work as well as it should over time.
Danish: Det betyder, at TOBI Podhaler med tiden måske ikke virker så godt, som det burde.
English: • After this if the capsule is still full and appears not to be pierced, replace the inhaler with the reserve inhaler and repeat Steps 2, 3, 6, 7, 8, 9 and 10.
Danish: • Hvis kapslen herefter stadig er fuld og ikke ser ud til at være punkteret, skiftes inhalatoren ud med reserveinhalatoren, og trin 2, 3, 6, 7, 8, 9 og 10 gentages.
English: However, aminoglycosides can cause foetal harm (e.g. congenital deafness) when high systemic concentrations are achieved in a pregnant woman.
Danish: Aminoglykosider kan dog forårsage fosterskader (f.eks. medfødt døvhed), når der nås høje systemiske koncentrationer hos en gravid kvinde.
English: If the capsule does not look pierced:
Danish: Hvis det ser ud til, at kapslen ikke er perforeret:
English: Mylan IRE Healthcare Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13 Ireland
Danish: Mylan IRE Healthcare Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13 Irland
English: In both studies, there was a trend for a recovery of P. aeruginosa density after the 28 days off-treatment period, which was reversed after a further 28 days on-treatment.
Danish: I begge studier var der en tendens til en genopretning af P. aeruginosa densiteten efter perioden på 28 dage uden behandling, hvilket blev vendt efter yderligere 28 dage med behandling.
English: • Other medicines which may harm your kidneys or hearing.
Danish: • Anden medicin, der kan skade dine nyrer eller din hørelse.
English: Cough was the most frequently reported adverse reaction in both clinical studies.
Danish: Hoste var den hyppigst rapporterede bivirkning i begge kliniske studier.
English: Each Podhaler device and its case are used for seven days and then discarded and replaced.
Danish: Hver Podhaler med hylster anvendes i syv dage, hvorefter den kasseres og erstattes med en ny.
English: The Podhaler inhalation device and its storage case are made from plastic materials (polypropylene).
Danish: Podhaleren og dens opbevaringshylster er fremstillet af plastmaterialer (polypropylen).
English: Look at the used capsule.
Danish: Se på den brugte kapsel.
English: The vast majority of adverse reactions reported with TOBI Podhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods.
Danish: Langt størstedelen af de rapporterede bivirkninger for TOBI Podhaler var lette eller moderate, og sværhedsgraden syntes ikke at afvige mellem cyklusserne eller mellem hele studiet og perioderne med behandling.
English: The two doses (of 4 capsules each) should be inhaled as close as possible to 12 hours apart and not less than 6 hours apart.
Danish: Intervallet mellem inhalering af de to doser (på hver 4 kapsler) skal være så tæt som muligt på 12 timer og ikke under 6 timer.
English: Patients after organ transplantation
Danish: Organtransplanterede patienter
English: Such coumpounds can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue.
Danish: Sådanne stoffer kan øge aminoglykosidtoksiciteten ved at ændre antibiotikakoncentrationerne i serum og væv.
English: • Decreasing hearing (ringing in the ears is a potential warning sign of hearing loss), noises (such as hissing) in the ears (common).
Danish: • Nedsat hørelse (ringen for ørerne er et potentielt advarselstegn på høretab), støj (fx susen) i ørerne (almindelig).
English: Adverse drug reactions in Table 1 are listed according to system organ classes in MedDRA.
Danish: Bivirkningerne i Tabel 1 er angivet efter systemorganklasserne i MedDRA.
English: Aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function.
Danish: Aminoglykosider kan forværre muskelsvaghed på grund af en potentiel curare-lignende effekt på den neuromuskulær funktion.
English: • Store in the original packaging in order to protect from moisture.
Danish: • Opbevares i den originale pakning for at beskytte mod fugt.
English: • Cough, productive cough, voice alteration (hoarseness)
Danish: • Hoste, produktiv hoste, stemmeændring (hæshed)
English: 56 capsules and 1 inhaler
Danish: 56 kapsler og 1 inhalator
English: There are no adequate data on the use of tobramycin via inhalation in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brug af tobramycin via inhalation hos gravide kvinder.
English: Cough was not related to bronchospasm.
Danish: Hosten var ikke relateret til bronkospasme.
English: Tobramycin showed no genotoxic potential in a battery of genotoxicity tests.
Danish: Tobramycin viste intet genotoksisk potentiale i et batteri af genotoksicitetstests.
English: Remove the inhaler from your mouth, and hold your breath for about 5 seconds.
Danish: Tag inhalatoren ud af munden, og hold vejret i ca. 5 sekunder.
English: The inhaler should never be washed with water.
Danish: Inhalatoren må aldrig vaskes med vand.
English: The first dose of TOBI Podhaler should be given under supervision, after using a bronchodilator if this is part of the current regimen for the patient.
Danish: Den første dosis af TOBI Podhaler skal gives under overvågning, efter brug af bronkodilatator, hvis dette indgår i det aktuelle regime for patienten.
English: Sulfuric acid (for pH adjustment)
Danish: Svovlsyre (til pH-justering)
English: • if you are allergic to tobramycin, to any type of aminoglycoside antibiotic, or to any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for tobramycin, andre aminoglykosid-antibiotika eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: Haemoptysis is a complication in cystic fibrosis and is more frequent in adults.
Danish: Hæmoptyse er en komplikation ved cystisk fibrose og er hyppigere hos voksne.
English: If you are aged 65 years or older, your doctor may perform additional tests to decide if TOBI Podhaler is right for you.
Danish: Hvis du er 65 år gammel eller derover, vil din læge måske foretage yderligere tests for at afgøre, om TOBI Podhaler er det rigtige til dig.
English: Strains of Pseudomonas can become resistant to treatment with an antibiotic over time.
Danish: Pseudomonas-stammer kan med tiden blive resistente over for behandling med et antibiotikum.
English: Pseudomonas aeruginosa Haemophilus influenzae Staphylococcus aureus Insusceptible Burkholderia cepacia Stenotrophomonas maltophilia Alcaligenes xylosoxidans
Danish: Pseudomonas aeruginosa Haemophilus influenzae Staphylococcus aureus Ikke følsomme Burkholderia cepacia Stenotrophomonas maltophilia Alcaligenes xylosoxidans
English: Do not take any TOBI Podhaler for the next 28 days
Danish: Tag ikke TOBI Podhaler de næste 28 dage
English: Tobramycin is an aminoglycoside antibiotic produced by Streptomyces tenebrarius.
Danish: Tobramycin er et aminoglykosid antibiotikum, som produceres af Streptomyces tenebrarius.
English: If you forget to take TOBI Podhaler and there are at least 6 hours to your next dose, take your dose as soon as you can.
Danish: Hvis du har glemt at tage TOBI Podhaler, og der er mindst 6 timer til din næste dosis, skal du tage din dosis, så snart du kan komme til det.
English: Repeat cycle
Danish: Gentag forløbet
English: Your doctor may ask you to use other appropriate medicines before taking TOBI Podhaler.
Danish: Din læge vil måske bede dig bruge andre hensigtsmæssige lægemidler, før du tager TOBI Podhaler.
English: After you have taken TOBI Podhaler for 28 days, you then have a 28-day break, during which you do not inhale any TOBI Podhaler.
Danish: Når du har taget TOBI Podhaler i 28 dage, skal du holde en pause på 28 dage, hvor du ikke inhalerer TOBI Podhaler.
English: Patients with haemoptysis (>60 ml) were excluded from the clinical studies so no data exist on the use of TOBI Podhaler in these patients.
Danish: Patienter med hæmoptyse (>60 ml) har været udelukket fra de kliniske studier, så der eksisterer ingen data vedrørende brug af TOBI Podhaler til disse patienter.
English: • The active substance is tobramycin.
Danish: • Aktivt stof: tobramycin.
English: No studies have been performed on patients with hepatic impairment.
Danish: Der er ikke foretaget studier med patienter med nedsat leverfunktion.
English: In general, toxicity is seen at higher systemic tobramycin levels than are achievable by inhalation at the recommended clinical dose.
Danish: Generelt ses toksicitet for tobramycin ved højere systemiske niveauer end dem, der kan opnås ved inhalation af den anbefalede kliniske dosis.
English: If the infection is not properly fought, it will continue to damage your lungs, causing further problems to your breathing.
Danish: Hvis infektionen ikke bekæmpes rigtigt, vil den fortsætte med at beskadige lungerne og give yderligere åndedrætsproblemer.
English: Suppression of sputum P. aeruginosa density was similar across age groups in both arms.
Danish: Suppressionen af ekspektorat P. aeruginosa densiteten var tilsvarende på tværs af aldersgrupper i begge arme.
English: Take TOBI Podhaler twice a day, every day for 28 days
Danish: Tag TOBI Podhaler to gange daglig hver dag i 28 dage
English: Pharmacotherapeutic group: Antibacterials for systemic use, Aminoglycoside antibacterials, ATC Code: J01GB01
Danish: Farmakoterapeutisk klassifikation: Antibakterielle midler til systemisk brug, aminoglykosider, ATCkode: J01GB01
English: Four patients in the TOBI Podhaler treatment group experienced significant decreases in hearing which were transient in three patients and persistent in one case.
Danish: Fire patienter i den gruppe, der blev behandlet med TOBI Podhaler, havde et betydende tab af hørelsen, som var forbigående hos tre patienter og vedvarende i ét tilfælde.
English: Patients who use TOBI Podhaler during pregnancy, or become pregnant while taking TOBI Podhaler, should be informed of the potential hazard to the foetus.
Danish: Patienter, der bruger TOBI Podhaler under en graviditet eller bliver gravide, mens de tager TOBI Podhaler, skal oplyses om den potentielle risiko for fostret.
English: Patients with known or suspected auditory or renal dysfunction should be monitored for serum tobramycin concentrations.
Danish: Patienter med kendt eller mistænkt auditiv eller renal dysfunktion skal monitoreres for serumkoncentrationer af tobramycin.
English: Tear the perforations along the length then width: see Figures (a) and (b).
Danish: Riv langs den perforerede foldelinje på langs og derefter på tværs: se Figur (a) og (b).
English: • The chances of the capsule breaking into pieces will be increased if the capsule is accidentally pierced more than once or if the device is not held with the mouthpiece pointing down during step 7.
Danish: • Risikoen for, at kapslen splintres, er større, hvis kapslen ved et uheld perforeres mere end én gang, eller hvis inhalatoren ikke holdes, så mundstykket vender nedad under trin 7.
English: Not known
Danish: Ukendt
English: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Danish: Desuden er den tilsvarende hyppighed anført for hver bivirkning efter nedenstående konvention (CIOMS III): 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); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Based on available data from animals a risk of toxicity (e.g. ototoxicity) at prenatal exposure levels cannot be excluded.
Danish: Baseret på tilgængelige data fra dyr kan en risiko for toksicitet (f.eks. ototoksicitet) ved prænatale eksponeringsniverauer ikke udelukkes.
English: Inhale the powder deeply with a single continuous inhalation.
Danish: Inhaler pulveret dybt i en enkelt, uafbrudt inhalation.
English: The following medicines can increase the chances of harmful effects occurring if they are given to you while you are also receiving injections of tobramycin or other aminoglycoside antibiotic:
Danish: Følgende medicin kan øge risikoen for bivirkninger, hvis du tager dem, mens du også får injektioner med tobramycin eller et andet aminoglykosid-antibiotikum:
English: 4 capsules = 1 dose
Danish: 4 kapsler = 1 dosis
English: Tinnitus may be a sentinel symptom of ototoxicity, and therefore the onset of this symptom warrants caution.
Danish: Tinnitus kan være et advarselssymptom på ototoksicitet, og forekommer dette symptom, er der således grund til at udvise forsigtighed.
English: Bronchospasm should be treated as medically appropriate.
Danish: Ved bronkospasme skal der gives hensigtsmæssig medicinsk behandling.
English: The amount of tobramycin excreted in human breast milk after administration by inhalation is not known, though it is estimated to be very low considering the low systemic exposure.
Danish: Den mængde tobramycin, der udskilles i human mælk efter indgivelse ved inhalation er ikke kendt, men den skønnes at være meget lille i betragtning af den lave systemiske eksponering.
English: The unique characteristics of chronic P. aeruginosa infections in CF patients, such as anaerobic conditions and high frequency of genetic mutations, may also be important factors for reduced susceptibility of P. aeruginosa in CF patients.
Danish: De unikke karakteristika af kronisk P. aeruginosa infektioner hos CF patienter, så som anaerobe forhold og høj frekvens af genetiske mutationer, kan også være vigtige faktorer for reduceret følsomhed af P. aeruginosa i CF patienter.
English: Serum concentrations greater than 12 µg/ml are associated with tobramycin toxicity and treatment should be discontinued if concentrations exceed this level.
Danish: Serumkoncentrationer, som overstiger 12 µg/ml er forbundet med tobramycintoksicitet, og behandlingen skal seponeres ved koncentrationer, der overstiger dette niveau.
English: In case of missed dose with at least 6 hours until the next dose, the patient should take the dose as soon as possible.
Danish: Hvis en dosis glemmes, og der er mindst 6 timer til næste dosis, skal patienten tage denne dosis så hurtigt som muligt.
English: See also information on previous and concomitant use of systemic aminoglycosides and diuretics in section 4.4.
Danish: Se også information om tidligere og samtidig brug af systemiske aminoglykosider og diuretika i pkt.
English: The serum concentration of tobramycin should only be monitored through validated methods.
Danish: Serumkoncentrationen af tobramycin bør kun monitoreres ved hjælp af validerede metoder.
English: 3 years Discard the Podhaler device and its case 1 week after first use.
Danish: 3 år Kassér Podhaleren med hylster 1 uge efter første anvendelse.
English: Each inhaler is only used for 7 days.
Danish: Hver inhalator må kun bruges i 7 dage.
English: • Look at the inhaler to make sure it is not damaged or dirty.
Danish: • Efterse inhalatoren for at sikre, at den ikke er beskadiget eller snavset.
English: TOBI Podhaler contains a medicine called tobramycin which is an antibiotic.
Danish: TOBI Podhaler indeholder lægemidlet tobramycin, som er et antibiotikum.
English: • Loss of voice
Danish: • Mistet stemme
English: It is a very common bacterium that infects the lungs of nearly everyone with cystic fibrosis at some time during their lives.
Danish: Den er en meget almindelig bakterie, der på et eller andet tidspunkt i livet inficerer lungerne hos næsten alle med cystisk fibrose.
English: • blood in your sputum (the substance you cough up)
Danish: • blod i opspyttet (den substans, du hoster op)
English: Before putting the mouthpiece in your mouth, breathe out fully, away from the inhaler.
Danish: Inden du tager mundstykket i munden, skal du ånde helt ud, væk fra inhalatoren.
English: Systemic exposure following inhalation of TOBI Podhaler is very low, however TOBI Podhaler should not be used during pregnancy unless clearly necessary, i.e. when the benefits to the mother outweigh the risks to the foetus.
Danish: Den systemiske eksponering efter inhalation af TOBI Podhaler er meget lav, dog bør TOBI Podhaler ikke anvendes under graviditet, medmindre det er absolut nødvendigt, dvs. når fordelene for moderen opvejer risiciene for fosteret.
English: It should appear punctured and empty.
Danish: Den skal være punkteret og tom.
English: No effect on male or female fertility was observed in animal studies after subcutaneous administration (see section 5.3).
Danish: Der er ikke observeret nogen effekt på mandlig eller kvindelig fertilitet i dyreforsøg efter subkutan indgivelse (se pkt.
English: Monthly pack.
Danish: Månedspakning.
English: In the placebo controlled study, patients were aged 6 - ≤22 years with an FEV1 at screening of between 25% and 84% of predicted normal values for their age, sex and height based upon Knudson criteria.
Danish: I det placebo-kontrollerede studie var patienterne 6 - ≤ 22 år gamle og havde ved screeningen en FEV1 mellem 25 % og 84 % af de forventede normalværdier for deres alder, køn og højde baseret på Knudson-kriterierne.