FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with both TOBI Podhaler and tobramycin 300 mg/5 ml nebuliser solution (TOBI) resulted in relative increases from baseline to day 28 of the third treatment cycle in percent predicted FEV1 of 5.8% and 4.7%, respectively.
Danish: Behandling med både TOBI Podhaler og tobramycin 300 mg/5 ml inhalationsvæske til nebulisator, opløsning (TOBI), resulterede i relative stigninger fra baseline til dag 28 i den tredje behandlingscyklus, i procent af forventet FEV1 på henholdsvis 5,8 % og 4,7 %.
English: Hold the foil close to where you are rolling back.
Danish: Hold folien tæt på blisteren, når du trækker tilbage.
English: • Remove the capsule from the card.
Danish: • Tag kapslen ud af kapselkortet.
English: • Set the mouthpiece aside on a clean, dry surface.
Danish: • Læg mundstykket på en ren, tør overflade.
English: Carcinogenicity studies with inhaled tobramycin do not increase the incidence of any variety of tumour.
Danish: Karcinogenicitetsforsøg med inhaleret tobramycin øger ikke forekomsten af nogen tumortype.
English: A population pharmacokinetic analysis for TOBI Podhaler in cystic fibrosis patients estimated the apparent volume of distribution of tobramycin in the central compartment to be 84.1 litres for a typical CF patient.
Danish: I en farmakokinetisk populationsanalyse af TOBI Podhaler hos patienter med cystisk fibrose blev det tilsyneladende fordelingsvolumen af tobramycin i det centrale kompartment vurderet til at være 84,1 liter for en typisk CF-patient.
English: • Anticholinesterases such as neostigmine and pyridostigmine (used to treat muscle weakness), or botulinum toxin.
Danish: • Anticholinesteraser, som fx neostigmin og pyridostigmin (bruges til behandling af muskelsvaghed) eller botulinumtoksin.
English: If you are taking one or more of the above medicines, discuss with your doctor before you take TOBI Podhaler.
Danish: Hvis du tager en eller flere af ovennævnte medicin, skal du tale med din læge om det, før du tager TOBI Podhaler.
English: The capsules should remain in the capsule card until you need to use them.
Danish: Kapslerne skal blive i kapselkortet, indtil de skal bruges.
English: The systemic exposure to tobramycin after inhalation of TOBI Podhaler is expected to be primarily from the inhaled portion of the medicinal product as tobramycin is not absorbed to any appreciable extent when administered via the oral route.
Danish: Den systemiske eksponering for tobramycin efter inhalation af TOBI Podhaler forventes især at være fra den inhalerede del af lægemidlet, da tobramycin ikke absorberes i nogen væsentlig grad, når det indgives oralt.
English: If you are taking tobramycin or another aminoglycoside antibiotic by injection, it can sometimes cause hearing loss, dizziness and kidney damage.
Danish: Hvis du tager tobramycin eller et andet aminoglykosid-antibiotikum som injektioner, kan det undertiden forårsage nedsat hørelse, svimmelhed og nyreskader.
English: A population pharmacokinetic analysis for TOBI Podhaler in cystic fibrosis patients aged 6 to 66 years estimated the apparent serum clearance of tobramycin to be 14 litres/h.
Danish: I en farmakokinetisk populationsanalyse af TOBI Podhaler hos patienter med cystisk fibrose i alderen 6 til 66 år blev den tilsyneladende serum clearance af tobramycin vurderet til at være 14 liter/t.
English: Put the pierced side of the capsule in first.
Danish: Læg kapslen i med den perforerede side først.
English: In the patients aged <20 years the increase from baseline percent predicted FEV1 was larger: 11.3% for TOBI Podhaler and 6.9% for the nebuliser solution after 3 cycles.
Danish: Hos patienter på <20 år var stigningen i forhold til baseline procent af forventet FEV1 større: 11,3 % for TOBI Podhaler og 6,9 % for inhalationsvæske til nebulisator, opløsning, efter 3 cyklusser.
English: Patients with serum creatinine 2 mg/dl or more and blood urea nitrogen (BUN) 40 mg/dl or more have not been included in clinical studies and there are no data in this population to support a recommendation for or against dose adjustment with TOBI Podhaler.
Danish: Patienter med serumkreatinin på 2 mg/dl (176,8 µmol/l) eller derover og blodureanitrogen (BUN) på 40 mg/dl (14,3 mmol/l) eller derover har ikke indgået i kliniske studier, og der foreligger ingen data om denne population, som understøtter en anbefaling for eller imod dosisjustering af TOBI Podhaler.
English: • Discard all the empty capsules.
Danish: • Smid alle tomme kapsler ud.
English: In patients with a predisposing risk due to previous prolonged, systemic aminoglycoside therapy it may be necessary to consider renal and audiological assessment before initiating TOBI Podhaler therapy.
Danish: Hos patienter med prædisponering på grund af tidligere langvarig, systemisk aminoglykosidbehandling, kan det være nødvendigt at overveje renal og auditiv vurdering, før behandling med TOBI Podhaler påbegyndes.
English: • Pierce the capsule by pressing firmly the blue button with your thumb as far as it will go, then release the button.
Danish: • Perforer kapslen ved at trykke hårdt på den blå knap med tommelfingeren, til den er helt i bund, og slip så knappen.
English: • When you start a new weekly pack of capsules, use the new inhaler that is supplied in the pack.
Danish: • Når du starter på en ny ugepakning, skal du bruge den nye inhalator, som følger med i pakningen.
English: Tobramycin is primarily excreted unchanged in the urine and renal function is expected to affect the exposure to tobramycin.
Danish: Tobramycin udskilles primært uændret i urinen, og nyrefunktionen forventes at påvirke eksponeringen af tobramycin.
English: • Blocked nose
Danish: • Tilstoppet næse
English: If you experience any of these, tell your doctor straight away.
Danish: Hvis du oplever nogen af disse bivirkninger, skal du straks sige det til din læge.
English: Then breathe out normally, away from the inhaler.
Danish: Ånd derefter normalt ud, væk fra inhalatoren.
English: Remove inhaler from mouth, and hold breath for approximately 5 seconds, then exhale normally away from the inhaler.
Danish: Fjern inhalatoren fra munden, og hold vejret i ca. 5 sekunder; ånd derefter ud på normal vis, væk fra inhalatoren.
English: If your underlying lung disease seems worse while taking TOBI Podhaler, tell your doctor straight away.
Danish: Hvis du synes, at din underliggende lungesygdom forværres, mens du tager TOBI Podhaler, skal du straks sige det til din læge.
English: Then peel back the foil by rolling it back from the capsule card to reveal one capsule at a time, see Figures (c) and (d).
Danish: Træk derefter folien tilbage fra kapselkortet, så der kommer en kapsel til syne ad gangen, se Figur (c) og (d).
English: • Put the capsule back into the inhaler chamber (step 6).
Danish: • Læg kapslen tilbage i inhalatorens kammer (trin 6).
English: TOBI Podhaler capsules must always be stored in the blister (capsule card), and only removed immediately before use.
Danish: TOBI Podhaler kapsler skal altid opbevares i blisteren (kapselkortet) og må først tages ud umiddelbart før brug.
English: These medicines may harm the kidneys or hearing.
Danish: Denne medicin kan være skadelig for nyrerne eller hørelsen.
English: 1 reserve inhaler inside.
Danish: 1 reserveinhalator i pakningen.
English: • Never place a TOBI Podhaler capsule directly into the mouthpiece of the device.
Danish: • Læg aldrig en TOBI Podhaler kapsel direkte ind i inhalatorens mundstykke.
English: Nephrotoxicity has been reported with the use of parenteral aminoglycosides.
Danish: Nefrotoksicitet er rapporteret i forbindelse med brug af parenterale aminoglykosider.
English: Discard the empty capsule.
Danish: Kassér den tomme kapsel.
English: There is a theoretical risk that patients being treated with TOBI Podhaler may develop P. aeruginosa isolates resistant to intravenous tobramycin over time (see section 5.1).
Danish: Der er en teoretisk risiko for, at patienter, der behandles med TOBI Podhaler, udvikler P. aeruginosaisolater, som med tiden bliver resistente over for intravenøs tobramycin (se pkt.
English: • Wheezing, rales (crackles)
Danish: • Pibende åndedræt, rallen (knasende)
English: After a few normal breaths away from the inhaler, perform a second inhalation from the same capsule.
Danish: Efter et par åndedrag uden inhalatoren foretages inhalation nummer to fra den samme kapsel.
English: TOBI Podhaler is indicated for the suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis.
Danish: TOBI Podhaler er indiceret til suppressionsterapi ved kronisk lungeinfektion forårsaget af Pseudomonas aeruginosa hos voksne og børn fra 6 år og opefter med cystisk fibrose (CF).
English: It should appear pierced and empty.
Danish: Den skal være perforeret og tom.
English: If you are taking several different inhaled treatments and following other therapies for cystic fibrosis, you should take TOBI Podhaler after all of these are done.
Danish: Hvis du får flere forskellige inhalationsbehandlinger og andre behandlinger for cystisk fibrose, skal du tage TOBI Podhaler til slut efter alt det andet.
English: If TOBI Podhaler is swallowed, don't worry but tell your doctor as soon as possible.
Danish: Hvis du har slugt TOBI Podhaler, skal du ikke være bekymret, men sige det til din læge snarest muligt.
English: TOBI Podhaler is used in patients aged 6 years and older who have cystic fibrosis to treat lung infections caused by bacteria called Pseudomonas aeruginosa.
Danish: TOBI Podhaler anvendes til patienter fra 6 år og opefter med cystisk fibrose til behandling af lungeinfektioner forårsaget af bakterien Pseudomonas aeruginosa.
English: • Only use the capsules with the inhaler provided in this pack.
Danish: • Brug kun kapslerne sammen med inhalatoren i denne pakning.
English: • Always keep the capsules in the capsule card until when you need to use them.
Danish: • Kapslerne skal altid blive i kapselkortet, indtil du skal bruge dem.
English: • Always keep the TOBI Podhaler capsules and device in a dry place.
Danish: • Opbevar altid TOBI Podhaler kapsler og -inhalator på et tørt sted.
English: In a randomised, double-blind, placebo-controlled, multicentre study, TOBI Podhaler 112 mg (4 x 28 mg capsules) was administered twice daily, for three cycles of 28 days on-treatment and 28 days off-treatment (a total treatment period of 24 weeks).
Danish: I et randomiseret, dobbeltblindet, placebo-kontrolleret multicenterstudie blev TOBI Podhaler 112 mg (4 x 28 mg kapsler) givet to gange dagligt i tre cyklusser på 28 dage med behandling og 28 behandlingsfri dage (en samlet behandlingsperiode på 24 uger).
English: Treatment with TOBI Podhaler should be continued on a cyclical basis for as long as the physician considers the patient is gaining clinical benefit from the treatment with TOBI Podhaler.
Danish: Den cykliske behandling med TOBI Podhaler skal fortsættes, så længe lægen vurderer, at patienten har klinisk fordel af behandlingen.
English: Inhale the powder deeply with a single breath.
Danish: Inhaler pulveret i et enkelt, dybt åndedrag.
English: Urea and creatinine levels should be reassessed after every 6 complete cycles of TOBI Podhaler therapy.
Danish: Serumcarbamid og -kreatinin skal revurderes efter hver 6. gennemført cyklus med TOBI Podhaler behandling.
English: Inhaling medicines can also cause cough and this can happen with TOBI Podhaler.
Danish: Inhalation af lægemidler kan også give hoste, og det kan ske med TOBI Podhaler.
English: In children under 13 years of age, discontinuations were more frequent in the TOBI nebuliser solution arm whereas in patients aged 13 to 19, discontinuation rates with both formulations were similar.
Danish: Hos børn under 13 år var behandlingsophør hyppigere i den arm med inhalationsvæske til nebulisator, opløsning (TOBI), hvorimod der hos patienter i alderen 13 til 19 år var en lignende hyppighed for behandlingsophør for begge formuleringer.
English: Tear along the perforations of the capsule card lengthwise then widthwise, as indicated in pictures (1) and (2).
Danish: Riv langs den perforerede foldelinje på kapselkortet, først på langs derefter på tværs, som vist på billede 1 og 2.
English: Talk to your doctor if you are concerned about this.
Danish: Tal med din læge, hvis du er i tvivl.
English: For the best results from this medicine, please use it as this leaflet instructs you.
Danish: De bedste resultater opnås, når medicinen anvendes som beskrevet i denne indlægsseddel.
English: Store in the original package in order to protect from moisture and only remove immediately before use.
Danish: Opbevares i den originale pakning for at beskytte mod fugt og må først tages ud lige før brug.
English: • Unusual difficulty in breathing with wheezing or coughing and chest tightness (common).
Danish: • Usædvanligt besvær med at trække vejret, pibende åndedræt, hoste eller trykken for brystet (almindelig).
English: Cough was reported with use of TOBI Podhaler in clinical studies.
Danish: Hoste blev rapporteret ved brug af TOBI Podhaler i kliniske studier.
English: Always take TOBI Podhaler exactly as your doctor has told you.
Danish: Tag altid TOBI Podhaler nøjagtigt efter lægens anvisning.
English: 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) Calcium chloride
Danish: 1,2-distearoyl-sn-glycero-3-phosphocholin (DSPC) Kalciumklorid
English: Each weekly carton contains 7 blisters (capsule cards) of 8 capsules each, and a Podhaler device in its storage case.
Danish: Hver ugepakning indeholder 7 blisters (kapselkort) med hver 8 kapsler og en Podhaler i opbevaringshylster.
English: However, no association was observed in either clinical study between the incidence of bronchospasm and cough events.
Danish: Der blev dog ikke observeret nogen sammenhæng mellem forekomsten af bronkospasme og hostetilfælde i nogen af de kliniske studier.
English: Bronchospasm can occur with inhalation of medicinal products and has been reported with TOBI Podhaler in clinical studies.
Danish: Bronkospasme kan forekomme ved inhalation af lægemidler og er rapporteret i forbindelse med TOBI Podhaler i kliniske studier.
English: This necessitates sputum concentrations of tobramycin after inhalation to be about ten-fold above the minimum inhibitory concentration (MIC) or higher for P. aeruginosa suppression.
Danish: Dette nødvendiggør ekspektorat koncentrationer af tobramycin efter inhalation på ti gange den mindste hæmmende koncentration (MIC) eller højere, for at suppression af P. aeruginosa kan opnås.
English: • Please read the instructions at the end of this leaflet for more information about how to use the inhaler.
Danish: • Læs brugsanvisningen, der er i slutningen af denne indlægsseddel for at få oplysninger om,
English: Inhaling medicines can cause chest tightness and wheezing and this can happen immediately after inhalation of TOBI Podhaler.
Danish: Inhalation af medicin kan forårsage trykken for brystet og pibende åndedræt, og det kan ske straks efter inhalation af TOBI Podhaler.
English: Because of the potential for ototoxicity and nephrotoxicity in infants, a decision should be made whether to terminate breast-feeding or discontinue treatment with TOBI Podhaler, taking into account the importance of the treatment to the mother.
Danish: På grund af risikoen for ototoksicitet og nefrotoksicitet hos spædbørn skal der, under hensyntagen til behandlingens vigtighed for moderen, træffes beslutning om, hvorvidt amningen skal ophøre, eller behandlingen med TOBI Podhaler skal seponeres.
English: If you inhale too much TOBI Podhaler, tell your doctor as soon as possible.
Danish: Hvis du inhalerer for meget TOBI Podhaler, skal du sige det til din læge hurtigst muligt.
English: Inhalation powder, hard capsules 56 capsules + 1 inhaler
Danish: Inhalationspulver, hårde kapsler 56 kapsler + 1 inhalator
English: TOBI Podhaler inhalation powder, hard capsules consist of a white to almost white powder for inhalation filled into clear colourless hard capsules with “NVR AVCI” imprinted in blue ink on one part of the capsule and the Novartis logo imprinted in blue on the other part of the capsule.
Danish: TOBI Podhaler inhalationspulver, hårde kapsler består af transparente, farveløse, hårde kapsler, som indeholder et hvidt eller næsten hvidt pulver, med “NVR AVCI” trykt i blåt på den ene del af kapslen og Novartis' logo trykt i blåt på den anden del af kapslen.
English: The improvement in percent predicted FEV1 was numerically greater in the TOBI Podhaler treatment group and was statistically non-inferior to TOBI nebuliser solution.
Danish: Forbedringen i procent forventet FEV1 var numerisk større i den gruppe, der blev behandlet med TOBI Podhaler, og var ikke statistisk ringere end TOBI, inhalationsvæske til nebulisator, opløsning.
English: In the event of accidental oral ingestion of TOBI Podhaler capsules, toxicity is unlikely as tobramycin is poorly absorbed from an intact gastrointestinal tract.
Danish: I tilfælde af oral indtagelse af TOBI Podhaler kapsler ved et uheld er toksicitet usandsynlig, da tobramycin absorberes dårligt fra en intakt mavetarmkanal.
English: Only TOBI Podhaler capsules are to be used in the Podhaler device.
Danish: Kun TOBI Podhaler kapsler må anvendes i Podhaleren.
English: Where patients are receiving several different inhaled medicinal products and chest physiotherapy, it is recommended that TOBI Podhaler is taken last.
Danish: Hvis patienten modtager flere forskellige medicinske inhalationsprodukter og lungefysioterapi, anbefales det, at TOBI Podhaler tages til sidst.
English: Treatment with TOBI Podhaler for 28 days resulted in a statistically significant reduction in P. aeruginosa sputum density (mean difference with placebo about 2.70 log10 in colony forming units/CFUs).
Danish: Behandling med TOBI Podhaler i 28 dage resulterede i en statistisk signifikant reduktion i desiteten af P. aeruginosa ekspektorat (gennemsnitlig forskel i forhold til placebo var omkring 2,70 log10 i kolonidannende enheder (CFUs)).
English: Subcutaneous administration of tobramycin did not affect mating behaviour or cause impairment of fertility in male or female rats.
Danish: Subkutan administration af tobramycin påvirkede ikke parringsadfærden og forårsagede ikke nedsættelse af fertiliteten hos han- eller hunrotter.
English: Tell your doctor or a pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Development of resistance during inhaled tobramycin therapy could limit treatment options during acute exacerbations; this should be monitored.
Danish: Udvikling af resistens under behandling med inhaleret tobramycin kan begrænse mulighederne for behandling under akutte forværringer.
English: Monitoring of serum tobramycin concentrations
Danish: Monitorering af serumkoncentrationer af tobramycin
English: • Replace the mouthpiece and repeat Steps 7, 8 and 9.
Danish: • Sæt mundstykket på igen, og gentag trin 7, 8 og 9.
English: Please check the order of medications with your doctor.
Danish: Tal med din læge om rækkefølgen.
English: TOBI Podhaler capsules must not be swallowed.
Danish: TOBI Podhaler kapsler må ikke synkes.
English: The most commonly reported adverse reactions in the main safety, active-controlled clinical study with TOBI Podhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.
Danish: De hyppigst indberettede bivirkninger fra det aktiv-kontrollerede kliniske hovedstudie om sikkerheden af TOBI Podhaler versus tobramycin inhalationsvæske til nebulisator, opløsning, hos patienter med cystisk fibrose med P. aeruginosa-infektion er hoste, produktiv hoste, feber, dyspnø, orofaryngeale smerter, dysfoni og hæmoptyse.
English: How to inhale your medicine with the Podhaler device • Only use Podhaler device contained in this pack.
Danish: Sådan inhaleres medicinen ved hjælp af Podhaleren • Brug kun den Podhaler, der ligger i pakningen.
English: Musculoskeletal chest pain
Danish: Muskuloskeletale brystsmerter
English: Each weekly carton contains 56 x 28 mg capsules (7 blisters with 8 capsules per blister), and a Podhaler device in its storage case.
Danish: Hver ugekarton indeholder 56 x 28 mg kapsler (7 blistere med 8 kapsler pr. blister) og en Podhaler i opbevaringshylster.
English: Place inhaler back in storage case and close tightly.
Danish: Læg inhalatoren i opbevaringshylstret igen, og luk det tæt til.
English: • Never wash the Podhaler device with water.
Danish: • Rengør aldrig Podhaleren med vand.
English: In patients with any evidence of auditory dysfunction, or those with a predisposing risk, it may be necessary to consider audiological assessment before initiating TOBI Podhaler therapy.
Danish: Hos patienter med et eller flere tegn på auditiv dysfunktion eller patienter med risiko for prædisponering kan det være nødvendigt at overveje en audiologisk vurdering, før behandling med TOBI Podhaler initieres.
English: Treatment with TOBI Podhaler for 28 days resulted in a statistically significant reduction in P. aeruginosa sputum density (-1.61 log10 CFUs), as did the nebuliser solution (-0.77 log10 CFUs).
Danish: Behandling med TOBI Podhaler i 28 dage resulterede i en statistisk signifikant reduktion i densiteten af P. aeruginosa ekspektorat (-1,61 log10 CFUs), hvilket også blev set for inhalationsvæske til nebulisator, opløsning (-0,77 log10 CFUs).
English: If you forget to take TOBI Podhaler
Danish: Hvis du har glemt at tage TOBI Podhaler
English: Do not use TOBI Podhaler capsules with any other device, and do not use the Podhaler device to take any other medicine.
Danish: TOBI Podhaler kapsler må ikke bruges sammen med andre inhalatorer, og Podhaleren må ikke bruges til at tage anden medicin.
English: TOBI Podhaler capsules must always be stored in the blister to protect from moisture and only removed immediately before use.
Danish: TOBI Podhaler kapsler skal altid opbevares i blisterpakningen for at beskytte mod fugt og må først tages ud umiddelbart før brug.
English: • 4 capsules in the evening to be inhaled using the Podhaler device.
Danish: • 4 kapsler om aftenen, inhaleret ved brug af Podhaleren.
English: Unscrew mouthpiece and remove the capsule from the chamber.
Danish: Skru mundstykket af, og tag kapslen ud af kammeret.
English: Inhale the capsule - 2nd breath:
Danish: Inhaler kapslen - 2. åndedrag
English: Patientreported convenience and overall treatment satisfaction (as collected through a patient-reported outcomes questionnaire) were consistently higher with TOBI Podhaler compared with tobramycin nebuliser solution in each cycle.
Danish: Patienterne gav i deres rapportering om brugervenlighed og generel tilfredshed med behandlingen (indsamlet via et spørgeskema med patientrapporterede resultater), konsekvent udtryk for større tilfredshed med TOBI Podhaler sammenlignet med tobramycin, inhalationsvæske til nebulisator, opløsning, i hver cyklus.
English: The safety and efficacy of TOBI Podhaler in children aged under 6 years have not been established.
Danish: Pædiatriske patienter TOBI Podhalers sikkerhed og virkning hos børn under 6 år er ikke klarlagt.
English: Package leaflet: Information for the user TOBI Podhaler 28 mg inhalation powder, hard capsules tobramycin
Danish: Indlægsseddel: Information til brugeren TOBI Podhaler 28 mg inhalationspulver, hårde kapsler tobramycin
English: Hypersensitivity to the active substance and any aminoglycoside, or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller andre aminoglykosider, eller over for et eller flere af hjælpestofferne anført i pkt.
English: • 4 capsules in the morning to be inhaled using the Podhaler device.
Danish: • 4 kapsler om morgenen, inhaleret ved brug af Podhaleren.