FrancophonIA/ELRC3.0 huggingface dataset:
English: A majority of the patients were tobramycin-experienced adults with chronic pulmonary P. aeruginosa infection.
Danish: Et flertal af patienterne var tobramycin-erfarne voksne med kronisk pulmonal P. aeruginosa-infektion.
English: Caregivers should provide assistance to children starting TOBI Podhaler treatment, particularly those aged 10 years or younger, and should continue to supervise them until they are able to use the Podhaler device properly without help.
Danish: De der tager vare på barnet bør yde hjælp til børn der starter behandling med TOBI Podhaler, især til dem i aldersgruppen 10 år eller yngre, og de bør fortsætte med at overvåge dem, indtil de er i stand til at bruge Podhaleren korrekt uden hjælp.
English: In addition, all patients were infected with P. aeruginosa as demonstrated by a positive sputum or throat culture (or bronchoalveolar lavage) within 6 months prior to screening, and also in a sputum culture taken at the screening visit.
Danish: Derudover havde alle patienterne en P. aeruginosa-infektion, som var påvist ved en positiv dyrkning af ekspektorat eller svælg podning (eller bronkoalveolær lavage) inden for 6 måneder før screeningen og desuden i enkultur i forbindelse med screeningsbesøget.
English: While the volume was shown to vary with body mass index (BMI) and lung function (as FEV1% predicted), model-based simulations showed that peak (Cmax) and trough (Ctrough) concentrations were not impacted markedly with changes in BMI or lung function.
Danish: Mens fordelingsvolumenet viste sig at variere med body mass index (BMI) og lungefunktion (som forventet FEV1%), viste modelbaserede simuleringer, at højeste (Cmax) og laveste (Ctrough) koncentrationer ikke var påvirket markant af ændringer i BMI eller lungefunktion.
English: However, subcutaneous administration of tobramycin during organogenesis was not teratogenic nor embryotoxic.
Danish: Subkutan indgivelse af tobramycin under organogenese var dog hverken teratogen eller embryotoksisk.
English: This antibiotic belongs to a class called aminoglycosides.
Danish: Dette antibiotikum tilhører en gruppe lægemidler kaldet aminoglykosider.
English: • Each capsule card contains 8 capsules (corresponding to a daily dose: content of 4 capsules to be inhaled in the morning and content of 4 capsules to be inhaled in the evening).
Danish: • Hvert kapselkort indeholder 8 kapsler (svarende til en dagsdosis: Indholdet af 4 kapsler inhaleres om morgenen, og indholdet af 4 kapsler inhaleres om aftenen).
English: Based upon in vitro data and/or clinical trial experience, the organisms associated with pulmonary infections in CF may be expected to respond to TOBI Podhaler therapy as follows:
Danish: Baseret på in vitro-data og/eller erfaring fra kliniske studier kan de organismer, der associeres med pulmonale infektioner ved CF forventes at respondere på behandling med TOBI Podhaler som følger:
English: • Vomiting, nausea
Danish: • Opkastninger, kvalme
English: Please read the following instructions carefully to learn how to use and care for your Podhaler device.
Danish: Læs følgende brugsanvisning omhyggeligt for at lære, hvordan du bruger og håndterer din TOBI Podhaler-inhalator.
English: • Amphotericin B, cefalotin, polymyxins (used to treat microbial infections), ciclosporin, tacrolimus (used to reduce the activity of immune system).
Danish: • Amphotericin B, cefalotin, polymyxiner (bruges til behandling af mikrobielle infektioner), ciclosporin, tacrolimus (bruges til at nedsætte immunsystemets aktivitet).
English: Immediately insert the capsule into the inhaler chamber.
Danish: Sæt straks kapslen i inhalatorens kammer.
English: The improvements in lung function achieved during the first treatment cycle were maintained during the two subsequent cycles of treatment with TOBI Podhaler.
Danish: De forbedringer af lungefunktionen, der blev opnået i løbet af den første behandlingscyklus, blev opretholdt i de to efterfølgende cyklusser med TOBI Podhaler behandling.
English: No interaction studies have been performed with TOBI Podhaler.
Danish: Der er ikke udført interaktionsstudier med TOBI Podhaler.
English: Common (may affect up to 1 in 10 people)
Danish: Almindelig (kan forekomme hos mellem 1 ud af 10 patienter)
English: These medicines may harm the kidneys.
Danish: Denne medicin kan være skadelig for nyrerne.
English: TOBI Podhaler has no or negligible influence on the ability to drive and use machines.
Danish: TOBI Podhaler påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: No reproduction toxicology studies have been conducted with tobramycin administered by inhalation.
Danish: Der er ikke foretaget reproduktionstoksikologiske forsøg med tobramycin administreret ved inhalation.
English: 2 x monthly multipack wrapped in foil
Danish: 2x multipakning til en måned i folieomslag
English: The clinical significance of changes in MICs of tobramycin for P. aeruginosa has not been clearly established in the treatment of cystic fibrosis patients.
Danish: Den kliniske betydning af ændringer i tobramycin-MIC'er for P. aeruginosa er ikke klart fastlagt i behandlingen af patienter med cystisk fibrose (CF).
English: TOBI Podhaler significantly improved lung function compared with placebo, as shown by the relative increase in percent predicted FEV1 of about 13% after 28 days of treatment.
Danish: TOBI Podhaler forbedrede lungefunktionen signifikant sammenlignet med placebo, hvilket viste sig ved en relativ stigning i procent af forventet FEV1 på omkring 13 % efter 28 dages behandling.
English: Do not overtighten.
Danish: Du må ikke skrue for stramt
English: These medicines may cause muscle weakness to appear or become worse..
Danish: Denne medicin kan forårsage eller forværre muskelsvaghed.
English: Tobramycin is eliminated from the systemic circulation primarily by glomerular filtration of the unchanged compound.
Danish: Tobramycin udskilles fra den systemiske cirkulation især ved glomerulær filtration af det uændrede stof.
English: If an allergic response is suspected, TOBI Podhaler should be discontinued.
Danish: Hvis der er mistanke om en allergisk reaktion, skal TOBI Podhaler seponeres.
English: Inhale the content of 4 capsules twice a day (4 capsules in the morning and 4 capsules in the evening), using the Podhaler device.
Danish: Inhaler indholdet af 4 kapsler to gange daglig (4 kapsler om morgenen og 4 kapsler om aftenen) ved brug af Podhaleren.
English: If clinical deterioration of pulmonary status is evident, additional or alternative anti-pseudomonal therapy should be considered.
Danish: Hvis det er tydeligt, at den pulmonale tilstand forringes, skal supplerende eller alternativ antipseudomonal terapi overvejes.
English: It must not be administered by any other route or using any other inhaler.
Danish: Præparatet må ikke indgives ad anden vej eller ved hjælp af en anden inhalator.
English: Children below the age of 13 years may be more likely to cough when treated with TOBI Podhaler compared with older subjects.
Danish: Børn under 13 år kan være mere tilbøjelige til at hoste, når de behandles med TOBI Podhaler, sammenlignet med ældre patienter.
English: In the active-controlled study, at least 89% of patients had P. aeruginosa isolates with MICs at least 15 times lower than mean post-dose sputum concentration, both at baseline and at the end of the third active treatment cycle.
Danish: I det aktiv-kontrollerede studie havde mindst 89 % af patienterne P. aeruginosa-isolater med MIC'er, som var mindst 15 gange lavere end middelkoncentrationen i ekspektorat efter dosering, både ved behandlingsstart og ved afslutningen af den tredje aktive behandlingscyklus.
English: Tobramycin serum concentrations may be helpful in monitoring overdosage.
Danish: Serumkoncentrationer af tobramycin kan være nyttige til monitorering af overdosering.
English: Briefly inspect the inhaler to make sure it is not damaged or dirty.
Danish: Efterse inhalatoren kort for at sikre, at den ikke er beskadiget eller snavset.
English: • Discoloration of the substance you cough up (sputum)
Danish: • Misfarvning af den substans, du hoster op (opspyttet)
English: If you are breast feeding, you should talk to your doctor before taking this medicine.
Danish: Hvis du ammer, skal du tale med din læge, før du tager dette lægemiddel.
English: TOBI Podhaler is supplied in monthly packs containing 4 weekly cartons and a reserve Podhaler device in its storage case.
Danish: TOBI Podhaler leveres i månedspakninger, som indeholder 4 ugekartoner og en reserve Podhaler i opbevaringshylster.
English: Adequate data do not exist for the use of TOBI Podhaler in patients after organ transplantation.
Danish: Der foreligger ikke tilstrækkelige data vedrørende anvendelse af TOBI Podhaler til organtransplanterede patienter.
English: After this if the capsule is still full and appears to be unpunctured, replace the inhaler with the reserve inhaler and try again.
Danish: Hvis kapslen herefter stadig er fuld og ikke ser ud til at være punkteret, udskiftes inhalatoren med reserveinhalatoren, og der forsøges igen.
English: In case of signs of acute toxicity, immediate withdrawal of TOBI Podhaler and testing of renal function are recommended.
Danish: I tilfælde af tegn på akut toksicitet anbefales øjeblikkeligt ophør med TOBI Podhaler og undersøgelse af nyrefunktionen.
English: Animal studies with tobramycin do not indicate a teratogenic effect (see section 5.3).
Danish: Dyreforsøg med tobramycin tyder ikke på nogen teratogen effekt (se pkt.
English: • Furosemide or ethacrynic acid, diuretics
Danish: • Furosemid eller etacrynsyre, diuretika
English: Observed benefits on lung function and P. aeruginosa suppression should be assessed in the context of the patient's tolerance of TOBI Podhaler.
Danish: Observerede fordele med hensyn til lungefunktion og P. aeruginosa-suppression skal vurderes i sammenhæng med patientens tolerance af TOBI Podhaler.
English: When the full dose (4 capsules) has been inhaled, wipe mouthpiece with a clean dry cloth.
Danish: Når den fulde dosis (4 kapsler) er inhaleret, tørres mundstykkes af med en ren, tør klud.
English: In the active controlled studies, all patients were aged >6years old (range 6-66 years) with an FEV1 % predicted at screening of between 24% and 76%.
Danish: I de aktiv-kontrollerede studier var alle patienterne >6 år gamle (mellem 6 og 66 år) og havde ved screeningen en FEV1% mellem 24 % og 70 % af det forventede.
English: Place your mouth over the mouthpiece - to make a tight seal.
Danish: Anbring munden over mundstykket, så der skabes en tæt forsegling.
English: When patients in the placebo treatment group were switched from placebo to TOBI Podhaler at the start of the second treatment cycle, they experienced a similar improvement from baseline in percent predicted FEV1.
Danish: Når patienter i placebo-gruppen blev skiftet fra placebo til TOBI Podhaler ved starten af den anden behandlingscyklus, oplevede de en lignende forbedring i procent af forventet FEV1 i forhold til baseline.
English: Other medicinal products that have been reported to increase the potential toxicity of parenterally administered aminoglycosides include: - amphotericin B, cefalotin, ciclosporin, tacrolimus, polymyxins (risk of increased nephrotoxicity); - platinum compounds (risk of increased nephrotoxicity and ototoxicity); - anticholinesterases, botulinum toxin (neuromuscular effects).
Danish: Andre lægemidler, om hvilke det er rapporteret, at de øger parenteralt indgivne aminoglykosiders potentielle toksicitet, omfatter: - amphotericin B, cefalotin, ciclosporin, tacrolimus, polymyxiner (risiko for øget nefrotoksicitet); - platinforbindelser (risiko for øget nefrotoksicitet og ototoksicitet); - anticholinesteraser, botulinumtoksiner (neuromuskulære virkninger).
English: Haemodialysis may be helpful in removing tobramycin from the body.
Danish: Hæmodialyse kan være nyttig til at fjerne tobramycin fra kroppen.
English: Concomitant use of TOBI Podhaler with diuretic compounds (such as ethacrynic acid, furosemide, urea or intravenous mannitol) is not recommended.
Danish: Samtidig brug af TOBI Podhaler og diuretiske stoffer (såsom etacrynsyre, furosemid, urea eller intravenøs mannitol) kan ikke anbefales.
English: Each Podhaler device is only used for 7 days.
Danish: Hver Podhaler må kun bruges i 7 dage.
English: If oto- or nephrotoxicity occurs in a patient receiving TOBI Podhaler, tobramycin therapy should be discontinued until serum concentration falls below 2 µg/ml.
Danish: Hvis oto- eller nefrotoksicitet opstår hos en patient, som modtager TOBI Podhaler, skal tobramycin seponeres, indtil serumkoncentrationen er faldet til under 2 µg/ml.
English: • Do not wash the inhaler with water.
Danish: • Rengør ikke inhalatoren med vand.
English: Over half of the patients in both the TOBI Podhaler and TOBI nebuliser solution treatment groups received new (additional) anti-pseudomonal antibiotics (64.9% and 54.5% respectively, the difference consisting mainly of oral ciprofloxacin use).
Danish: Over halvdelen af patienterne i både TOBI Podhaler og TOBI inhalationsvæske til nebulisator, opløsning, behandlingsgrupperne modtog ny (yderligere) anti-pseudomonal antibiotika (henholdsvis 64,9% og 54,4%, forskellen bestod hovedsagligt af oral ciprofloxacin).
English: Based on the interaction profile for tobramycin following intravenous and aerosolised administration, concurrent and/or sequential use of TOBI Podhaler is not recommended with other medicinal products with nephrotoxic or ototoxic potential.
Danish: Baseret på interaktionsprofilen for tobramycin efter intravenøs og nebuliseret administration kan sideløbende og/eller gentagen brug af TOBI Podhaler ikke anbefales sammen med andre lægemidler med nefrotoksisk eller ototoksisk potentiale.
English: In the active-controlled study, administration of a TOBI Podhaler dose was faster with a mean difference of approximately 14 minutes (6 minutes vs. 20 minutes with the nebuliser solution).
Danish: I det aktivt-kontrolleret studie var administration af en TOBI Podhaler dosis hurtigere med en gennemsnitlig forskel på ca. 14 minutter (6 minutter mod 20 minutter med inhalationsvæske til nebulisator, opløsning).
English: Patients who were randomised to the placebo treatment group received placebo during the first treatment cycle and TOBI Podhaler in the subsequent two cycles.
Danish: Patienter, som blev randomiseret til placebo-behandlingsgruppen, fik placebo i den første behandlingscyklus og TOBI Podhaler i de efterfølgende to cyklusser.
English: • So for each remaining capsule, repeat steps 5,6, 7, 8, 9,
Danish: • For hver af de resterende kapsler gentages altså trin 5, 6,
English: When you inhale TOBI Podhaler, the antibiotic can enter directly into your lungs to fight against the bacteria causing the infection and to improve your breathing.
Danish: Når TOBI Podhaler inhaleres, kommer det antibiotiske stof direkte ned i lungerne, hvor det bekæmper den bakterie, der er årsag til infektionen, så din vejrtrækning forbedres.
English: Patients receiving concomitant parenteral aminoglycoside therapy (or any medication affecting renal excretion, such as diuretics) should be monitored as clinically appropriate taking into account the risk of cumulative toxicity.
Danish: Patienter, som samtidig behandles med parenterale aminoglykosider (eller anden medicin, der påvirker udskillelsen gennem nyrerne, såsom diuretika), skal være under passende klinisk monitorering på grund af risikoen for kumulativ toksicitet.
English: Clear colourless capsules containing a white to almost white powder, with “NVR AVCI” printed in blue on one part of the capsule and Novartis logo printed in blue on the other part of the capsule.
Danish: Transparente, farveløse 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: Inspect the used capsule.
Danish: Undersøg den brugte kapsel.
English: • Platinum compounds such as carboplatin and cisplatin (used to treat some forms of cancer).
Danish: • Platinforbindelser, såsom carboplatin og cisplatin (bruges til behandling af nogle typer kræft).
English: • Chest discomfort, chest pain from muscles or skeletal origins
Danish: • Ubehag i brystet, brystsmerter, der udspringer fra muskler eller skelettet
English: In the absence of conventional susceptibility breakpoints for the inhaled route of administration, caution must be exercised in defining organisms as susceptible or insusceptible to inhaled tobramycin.
Danish: I mangel af konventionelle følsomhedsbreakpoints for administration via inhalation skal der udvises forsigtighed i forbindelse med at definere organismer som følsomme eller ufølsomme for inhaleret tobramycin.
English: If the capsule is punctured but still contains some powder, place it back into the inhaler and take another two inhalations from the capsule.
Danish: Hvis kapslen er punkteret, men stadig indeholder noget pulver, sættes den tilbage i inhalatoren, og der tages endnu to inhalationer fra kapslen.
English: Non-clinical data reveal that the main hazard for humans, based on studies of safety pharmacology, repeated dose toxicity, genotoxicity, or toxicity to reproduction, consists of renal toxicity and ototoxicity.
Danish: Prækliniske data viser, at den største risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet eller reproduktionstoksicitet består i nyretoksicitet og ototoksicitet.
English: Furthermore, an improvement of 6% in percent predicted FEV1 was obtained in about 30% versus 36% of the adult patients in the TOBI Podhaler and TOBI nebuliser solution group respectively.
Danish: Herudover blev en forbedring på 6% i procent forventet FEV1 opnået hos omkring 30% versus 36% af de voksne patienter i grupperne med henholdsvis TOBI Podhaler og TOBI inhalationsvæske til nebulisator, opløsning.
English: This should be taken into account before prescribing TOBI Podhaler, considering the inhalation powder TOBI Podhaler was associated with a higher rate of cough (see above).
Danish: Dette bør tages i betragtning før TOBI Podhaler ordineres, da TOBI Podhaler inhalationspulver var forbundet med en højere frekvens af hoste (se ovenfor).
English: In clinical studies, patients receiving TOBI Podhaler continued to take dornase alfa, bronchodilators, inhaled corticosteroids and macrolides, no evidence of drug interactions with these medicines was identified.
Danish: I kliniske studier, hvor patienter, som fik TOBI Podhaler, fortsatte med at tage dornase alfa, bronkodilatatorer, inhalerede kortikosteroider og makrolider, er der ikke fundet tegn på interaktioner med disse lægemidler.
English: Fully exhale away from the inhaler.
Danish: Ånd helt ud væk fra inhalatoren.
English: The proportions of patients requiring hospitalisation for respiratory events were 24.4% with TOBI Podhaler and 22.0% with TOBI nebuliser solution.
Danish: Den andel af patienter, der skulle hospitalsindlægges for respiratoriske episoder var 24,4% med TOBI Podhaler og 22,0% med TOBI inhalationsvæske til nebulisator, opløsning.
English: Established susceptibility breakpoints for parenteral administration of tobramycin are inappropriate in the aerosolised administration of the medicinal product.
Danish: Fastlagte følsomhedsgrænser (break-points) for parenteral administration af tobramycin er uhensigtsmæssige ved administration af lægemidlet som aerosolinhalation.
English: Adverse reactions specifically associated with overdose of TOBI Podhaler have not been identified.
Danish: Bivirkninger specifikt i forbindelse med overdosering af TOBI Podhaler er ikke konstateret.
English: Serum concentrations
Danish: Serumkoncentrationer
English: Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected neuromuscular disorders such as myasthenia gravis or Parkinson's disease.
Danish: Der skal udvises forsigtighed ved ordination af TOBI Podhaler til patienter med kendte eller mistænkte neuromuskulære lidelser såsom myasthenia gravis eller Parkinsons sygdom.
English: TOBI Podhaler is a powder for inhalation that is filled into capsules.
Danish: TOBI Podhaler er et inhalationspulver, der er fyldt i kapsler.
English: The following pack sizes are available:
Danish: Følgende pakningsstørrelser markedsføres:
English: You should not take the following medicines while you are taking TOBI Podhaler:
Danish: Du må ikke tage følgende medicin, mens du får TOBI Podhaler:
English: Tobramycin is excreted in human breast milk after systemic administration.
Danish: Tobramycin udskilles i human mælk efter systemisk indgivelse.
English: The TOBI Podhaler Phase III clinical development programme consisted of two studies and 612 treated patients with a clinical diagnosis of CF, confirmed by quantitative pilocarpine iontophoresis sweat chloride test or well-characterised disease causing mutations in each cystic fibrosis transmembrane regulator (CFTR) gene, or abnormal nasal transepithelial potential difference characteristic of CF.
Danish: Det kliniske TOBI Podhaler fase III-udviklingsprogram bestod af to studier og 612 behandlede patienter med klinisk diagnosticeret CF, bekræftet ved en kvantitativ pilocarpin-iontophoresisesvedkloridtest eller velkarakteriseret sygdom med mutationer i begge cystisk fibrose transmembran regulator (CFTR)-gener, eller unormal nasal transepitel potentialforskelle, som er karakteristisk for CF.
English: The use of TOBI Podhaler in patients with clinically significant haemoptysis should be undertaken or continued only if the benefits of treatment are considered to outweigh the risks of inducing further haemorrhage.
Danish: Brug af TOBI Podhaler til patienter med klinisk signifikant hæmoptyse bør kun finde sted eller fortsætte, hvis fordelene ved behandlingen anses for at opveje risiciene for at fremkalde yderligere blødning.
English: If a patient reports tinnitus or hearing loss during TOBI Podhaler therapy the physician should consider referring them for audiological assessment.
Danish: Hvis en patient rapporterer tinnitus eller nedsat hørelse under behandling med TOBI Podhaler, skal lægen overveje at henvise patienten til audiologisk vurdering.
English: Vestibular toxicity may be manifested by vertigo, ataxia or dizziness.
Danish: Vestibulær toksicitet kan manifestere sig ved ataksi eller svimmelhed.
English: TOBI Podhaler is taken in alternating cycles of 28 days on treatment followed by 28 days off treatment.
Danish: TOBI Podhaler skal tages i cyklusser, hvor 28 dages behandling alternerer med 28 behandlingsfri dage.
English: Ototoxicity, manifested as both auditory toxicity (hearing loss) and vestibular toxicity, has been reported with parenteral aminoglycosides.
Danish: Ototoksicitet, der kan manifestere sig som både auditiv toksicitet (nedsat hørelse) og vestibulær toksicitet er rapporteret i forbindelse med parenterale aminoglykosider.
English: If there is evidence of therapy-induced bronchospasm, the physician should carefully evaluate whether the benefits of continued use of TOBI Podhaler outweigh the risks to the patient.
Danish: Hvis der er tegn på behandlingsfremkaldt bronkospasme, skal lægen foretage en omhyggelig vurdering af, om fordelene ved fortsat brug af TOBI Podhaler opvejer risiciene for patienten.
English: The recommended dose is 112 mg tobramycin (4 x 28 mg capsules), administered twice daily for 28 days.
Danish: Den anbefalede dosis er 112 mg tobramycin (4 x 28 mg kapsler) to gange dagligt i 28 dage.
English: Set the mouthpiece aside on a clean, dry surface.
Danish: Læg mundstykket på en ren, tør overflade.
English: • Other medicines with diuretic properties such as urea or intravenous mannitol
Danish: • Anden medicin med diuretiske egenskaber, som fx urinstoffer eller intravenøs mannitol
English: If there is evidence of continued therapy-induced cough with TOBI Podhaler, the physician should consider whether an approved tobramycin nebuliser solution should be used as an alternative treatment.
Danish: Hvis der er tegn på fortsat terapifremkaldt hoste i forbindelse med TOBI Podhaler, skal lægen overveje, om en godkendt tobramycin opløsning til nebulisator skal anvendes som alternativ behandling.