FrancophonIA/ELRC3.0 huggingface dataset:
English: The first dose of Vantobra should be used under supervision of a physician, after taking a bronchodilator if this is part of the current regimen for the patient.
Danish: Den første dosis Vantobra bør anvendes under overvågning af en læge, efter at der er taget en bronkodilatator, hvis dette er en del af det nuværende regimen for patienten.
English: Do not use the Tolero nebuliser handset for any other medicine.
Danish: Lad være at bruge Tolero nebuliser-håndsættet til nogen anden medicin.
English: • Lay out all the pieces of your Tolero nebuliser handset on a clean, dry paper or cloth towel.
Danish: • Læg alle stykkerne fra dit Tolero nebuliser-håndsæt ud på et rent, tørt håndklæde af papir eller stof.
English: Long-term safety data are not available for Vantobra (see also section 5.1).
Danish: Længerevarende sikkerhedsdata forefindes ikke for Vantobra (se også pkt.
English: There are insufficient data in this population to support a recommendation for or against dose adjustment.
Danish: Der er utilstrækkelige data om denne population til at understøtte en anbefaling for eller imod dosisjustering.
English: Geometric Standard Deviation ±SD 1.5 ± 0.0 Nebulisation Time [min]
Danish: Geometrisk standardafvigelse ±SD 1,5 ± 0,0 Nebulisationstid [min]
English: Safety and efficacy have not been studied in patients colonised with Burkholderia cepacia.
Danish: Sikkerheds- og effektdata er ikke blevet genereret hos patienter koloniseret med Burkholderia cepacia.
English: In the case of any overdose, the possibility of drug interactions with alterations in the elimination of Vantobra or other medicinal products should be considered.
Danish: I tilfælde af enhver overdosering bør muligheden for lægemiddelinteraktioner med ændring i eliminationen af Vantobra eller andre lægemidler overvejes.
English: No effect on male or female fertility was observed in animal studies after subcutaneous administration (see section 5.3).
Danish: Der blev ikke observeret nogen effekt på mandlig eller kvindelig fertilitet i dyreforsøg efter subkutan administration (se pkt.
English: • if you are allergic (hypersensitive) to tobramycin, to any type of aminoglycoside antibiotics, or to any of the other ingredients of Vantobra (listed in section 6).
Danish: • Hvis du er allergisk (overfølsom) over for tobramycin, over for nogen type af aminoglycosid antibiotika eller over for nogen af de øvrige indholdsstoffer i Vantobra (angivet i punkt 6).
English: Your doctor may ask you to use other appropriate medicines to widen the airways before using Vantobra.
Danish: Din læge vil måske bede dig om at anvende andre passende lægemidler til at udvide luftvejene inden brugen af Vantobra.
English: Limited data from one controlled clinical study over one treatment cycle indicate that the improvement in lung function was maintained above baseline during the 28-day off-treatment period.
Danish: Begrænsede data fra ét kontrolleret klinisk forsøg over én behandlingscyklus indikerer, at forbedringen i lungefunktion blev opretholdt over baseline under 28-dages perioden uden behandling.
English: • blood in your sputum (the substance you cough up);
Danish: • Blod i dit spyt (substansen, du hoster op)
English: If less than 6 hours remain to the next planned dose, the patient should wait for the next dose and not inhale more to make up for the missed dose.
Danish: Hvis der er mindre end 6 timer tilbage til den næste planlagte dosis, bør patienten vente til den næste dosis og ikke inhalere mere for at kompensere for den oversprungne dosis.
English: To re-start the treatment, press and hold the On/Off button again for one full second to resume treatment.
Danish: For at genstarte behandlingen trykkes On/Off knappen igen ned og holdes nede ét fuldt sekund for at genoptage behandlingen.
English: Subcutaneous administration at doses of 100 mg/kg/day in rats and the maximum tolerated dose of 20 mg/kg/day in rabbits during organogenesis was not teratogenic.
Danish: Subkutan administration med doser på 100 mg/kg/dag hos rotter og den maksimalt tolererede dosis på 20 mg/kg/dag hos kaniner under organogenese var ikke teratogene.
English: • coughing up blood, producing more sputum than normally, chest discomfort, asthma, fever
Danish: • hosten blod op, producerende mere spyt end normalt, ubehag i brystet, astma, feber
English: Strains of Pseudomonas can become resistant to treatment with an antibiotic over time.
Danish: Stammer af Pseudomonas kan blive resistente over for behandling med et antibiotikum med tiden.
English: As a result of study 12012.101, lung function improvement FEV1% predicted relative to baseline increased by 8.2 ± 9.4% under Vantobra and by 4.8 ± 9.6% under the reference therapy in the first treatment cycle showing non-inferior (p=0.0005) efficacy.
Danish: Som et resultat af forsøg 12012.101, øgedes forbedring i lungefunktion FEV1 % forudsagt relativt til baseline med 8,2 ± 9,4 % under Vantobra og med 4,8 ± 9,6 % under referencebehandlingen i den første behandlingscyklus visende non-inferior (p=0.0005) effekt.
English: • voice alteration (hoarseness)
Danish: • ændring af stemmen (hæshed)
English: These medicines may cause muscle weakness to appear or become worse.
Danish: Disse lægemidler kan medføre fremkaldelse af muskelsvækkelse eller gøre den værre.
English: Do not use an alternative untested nebuliser system because it may alter the amount of medicine reaching the lungs.
Danish: Brug ikke et alternativt, utestet nebuliser-system, da det kan ændre mængden af lægemiddel, der når frem til lungerne.
English: Vantobra should not be used during pregnancy unless the benefits to the mother outweigh the risks to the foetus or baby.
Danish: Vantobra bør ikke anvendes under graviditet, medmindre fordelene for moderen opvejer risici for føtus eller det lille barn.
English: Continue to inhale and exhale comfortably until the treatment is finished.
Danish: Fortsæt med bekvemt at ånde ind og ånde ud, indtil behandlingen er afsluttet.
English: Any unused medicinal product or waste material should be disposed off in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: • The nebuliser handset must be kept horizontally during operation.
Danish: • Nebuliser-håndsættet skal holdes horisontalt under betjeningen.
English: The development of antibiotic-resistant P. aeruginosa and superinfection with other pathogens represent potential risks associated with antibiotic therapy.
Danish: Udviklingen af antibiotika-resistent P. aeruginosa og superinfektion med andre patogener repræsenterer potentielle risici forbundet med antibiotisk behandling.
English: • Make sure you have an eFlowrapid or eBase controller to connect the Tolero nebuliser handset.
Danish: • Vær sikker på, at du har en eFlowrapid eller eBase controller at tilslutte til Tolero nebuliserhåndsættet.
English: Hearing loss Tinnitus
Danish: Høretab Tinnitus
English: The elimination half-life of tobramycin from serum is approximately 2 hours.
Danish: Eliminationshalveringstiden for tobramycin fra serum er cirka 2 timer.
English: There is no evidence that patients treated with up to 18 months with tobramycin nebuliser solution were at a greater risk for acquiring B. cepacia, S. maltophilia or A. xylosoxidans, than would be expected in untreated patients.
Danish: Der er intet bevis for, at patienter behandlet op til 18 måneder med tobramycin nebuliser-opløsning var udsat for større risiko for at pådrage sig B. cepacia, S. maltophilia eller A. xylosoxidans, end det kunne forventes hos ubehandlede patienter.
English: If an allergic response is suspected, Vantobra should be discontinued.
Danish: Hvis der er mistanke om et allergisk respons, bør Vantobra seponeres.
English: • laryngitis (inflammation of the voice box that can cause voice alteration, sore throat and difficulty swallowing)
Danish: • laryngitis (inflammation af stemmebåndene, der kan medføre ændring af stemmen, ondt i halsen og synkebesvær)
English: The following medicines can increase the risks of harmful effects occurring if they are given to you while you also take tobramycin or another aminoglycoside antibiotic given by injection:
Danish: Følgende lægemidler kan øge risikoen for skadelige virkninger, der kan forekomme, hvis de bliver givet til dig, mens du også tager tobramycin eller andre aminoglycosid antibiotika som injektion:
English: These medicines may harm the kidneys or hearing.
Danish: Disse lægemidler kan beskadige nyrerne eller hørelsen.
English: • hearing problems (including noises in your ears and dizziness);
Danish: • Høreproblemer (inklusive støj i ørene og svimmelhed)
English: • muscle weakness that lasts or becomes worse over time, a symptom mostly related to conditions such as myasthenia (muscle weakness) or Parkinson's disease.
Danish: • Muskelsvaghed, der varer ved eller bliver værre med tiden, et symptom oftest relateret til tilstande såsom myastheni (muskelsvækkelse) eller Parkinson's disease.
English: Symptoms of aerosol overdose may include severe hoarseness.
Danish: Symptomer på aerosol overdosering kan omfatte kraftig hæshed.
English: However, aminoglycosides can cause foetal harm (e.g., congenital deafness and nephrotoxicity) when high systemic concentrations are achieved in a pregnant woman.
Danish: Aminoglycosider kan imidlertid medføre føtal skade (f.eks. kongenital døvhed og nefrotoksicitet), når der opnås høje, systemiske koncentrationer hos en gravid kvinde.
English: Treatment should be continued on a cyclical basis for as long as the physician considers the patient is gaining clinical benefit from the treatment taking into account that long-term safety data are not available for Vantobra.
Danish: Behandlingen bør fortsættes på en cyklisk basis lige så længe, som lægen skønner, at patienten drager klinisk fordel af behandlingen, idet det tages i betragtning, at sikkerhedsdata på længere sigt ikke er tilgængelige for Vantobra.
English: Aerosol characteristics
Danish: Aerosol karakteristika
English: Patients with known or suspected auditory or renal dysfunction should be monitored for serum tobramycin concentrations.
Danish: Patienter med kendt eller mistanke om auditorisk eller renal dysfunktion bør monitoreres for serumtobramycinkoncentrationer.
English: Diarrhoea Abdominal pain
Danish: Diarré Abdominalsmerter
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 Vantobra therapy as follows:
Danish: Baseret på in-vitro data og/eller erfaring fra kliniske afprøvninger, kan organismerne forbundet med lungeinfektioner i CF forventes at respondere på behandling med Vantobra som følger:
English: • Inhale by mouth the full content of one ampoule in the morning, and one ampoule in the evening using the Tolero nebuliser handset.
Danish: • Inhalér gennem munden hele indholdet af én ampul om morgenen, og én ampul om aftenen ved brug af Tolero nebuliser-håndsættet.
English: In general, toxicity is seen at higher systemic tobramycin levels than are achievable by inhalation of the recommended clinical dose.
Danish: Generelt ses toksicitet ved højere systemiske tobramycinniveauer, end der forefindes ved inhalation af den anbefalede kliniske dosis.
English: Vantobra must not be administered by any other route or using any other device than the one provided in the pack.
Danish: Vantobra må ikke administreres ad nogen anden vej eller ved brug af nogen anden anordning end den, der leveres i pakningen.
English: Insusceptible Burkholderia cepacia Stenotrophomonas maltophilia Alcaligenes xylosoxidans
Danish: Burkholderia cepacia Stenotrophomonas maltophilia Alcaligenes xylosoxidans
English: Serum concentrations greater than 12 µg/ml are associated with tobramycin toxicity and treatment should be discontinued if concentrations exceed this level.
Danish: Serum-koncentrationer højere end 12 µg/ml er forbundet med tobramycintoksicitet og behandlingen bør seponeres, hvis koncentrationerne overskrider dette niveau.
English: As it is preservative-free, the contents of the whole ampoule should be used immediately after opening and any unused solution should be discarded.
Danish: Da det er fri for konserveringsmidler, skal hele ampullens indhold bruges med det samme efter åbning, og al ubrugt opløsning bør kasseres.
English: This in turn may alter how well the medicine works and its safety.
Danish: Dette kan igen ændre, hvorledes lægemidlet virker og dets sikkerhed.
English: • headache, weakness
Danish: • hovedpine, svaghed
English: When you inhale Vantobra, the antibiotic can enter directly into your lungs to fight the bacteria causing the infection.
Danish: Når du inhalerer Vantobra, kan antibiotikummet gå direkte ned i dine lunger for at bekæmpe de bakterier, der medfører infektionen.
English: • worsening of lung function test results
Danish: • forværring af testresultater for lungefunktion
English: If Vantobra is used during pregnancy, or if the patient becomes pregnant while taking Vantobra, she should be informed of the potential hazard to the foetus.
Danish: Hvis Vantobra anvendes under graviditet, eller hvis patienten bliver gravid, mens hun tager Vantobra, bør hun oplyses om de potentielle farer for føtus.
English: The recommended dose is one ampoule (170 mg/1.7 ml) administered twice daily (i.e. total daily dose is 2 ampoules) for 28 days.
Danish: Den anbefalede dosis er én ampul (170 mg/1,7 ml) administreret to gange daglig (dvs. den totale daglige dosis er 2 ampuller) i 28 dage.
English: Tobramycin is excreted in human breast milk after systemic administration.
Danish: Tobramycin udskilles i human modermælk efter systemisk administration.
English: Treatment with the 28-days on and 28-days off dose regimen in clinical studies showed a small but clear increase in tobramycin, amikacin and gentamicin MICs for P. aeruginosa isolates tested.
Danish: Behandling med 28 dage med og 28 dage uden dosisregime i kliniske forsøg viste, at en lille, men tydelig øgning i tobramycin, amikacin og gentamicin MIC'er for P. aeruginosa isolater testet.
English: It is bactericidal at concentrations equal to or slightly greater than inhibitory concentrations.
Danish: Det er baktericidt ved koncentrationer lig med eller en anelse større end hæmningskoncentrationer.
English: • Hold the ampoule upright and tap lightly before twisting off the head part to avoid spilling.
Danish: • Hold ampullen opret og bank let på den inden topdelen drejes af, for at undgå at spilde.
English: Do not use Vantobra:
Danish: Brug ikke Vantobra:
English: Established susceptibility breakpoints for parenteral administration of tobramycin are inappropriate in the aerosolised administration of the medicinal product.
Danish: Fastlagte breakpoints for følsomhed ved parenteral administration af tobramycin er uhensigtsmæssige ved den aerosolbaserede administration af lægemidlet.
English: If you have questions about how long to use Vantobra, talk to your doctor or pharmacist.
Danish: Hvis du har spørgsmål om, hvor længe du skal bruge Vantobra, så tal med din læge eller apotekspersonalet.
English: Outer box contains:
Danish: Ydre æske indeholder:
English: The contents of a single-dose ampoule should be used immediately after opening (see section 6.6).
Danish: Indholdet af en enkelt-dosis ampul bør anvendes straks efter åbning (se pkt.
English: • Read the Instructions for Use provided with the handset device before use.
Danish: • Læs brugsanvisningen, der kommer med håndsættet, inden brugen.
English: In repeated dose toxicity studies it has been shown that target organs of toxicity are the kidneys and vestibular/cochlear functions.
Danish: I toksicitetsstudier efter gentagne doser er det blevet påvist, at målorganer for toksicitet er funktionen af nyrerne og vestibular/cochlear funktioner.
English: Administration by inhalation results in low systemic bioavailability of tobramycin.
Danish: Administration ved inhalation resulterer i lav systemisk biotilgængelighed af tobramycin.
English: Preparing Vantobra for inhalation
Danish: Klargøring af Vantobra til inhalation
English: Bronchospasm can occur with inhalation of medicinal products and has been reported with the use of nebulised tobramycin.
Danish: Bronkospasme kan forekomme ved inhalation af lægemidler og er blevet rapporteret ved brugen af nebuliseret tobramycin.
English: Pseudomonas aeruginosa is a bacterium that frequently infects the lungs of cystic fibrosis patients at some time during their lives.
Danish: Pseudomonas aeruginosa er en bakterie, der hyppigt inficerer lungerne hos patienter med cystisk fibrose på nogle tidspunkter i deres liv.
English: Vantobra should be used with great caution in patients with neuromuscular disorders such as Parkinsonism or other conditions characterized by myasthenia, including myasthenia gravis, as aminoglycosides may aggravate muscle weakness due to a potential curare-like effect on neuromuscular function.
Danish: Vantobra bør anvendes med stor forsigtighed hos patienter med neuromuskulære lidelser, såsom Parkinsonisme eller andre tilstande karakteriseret ved myastheni, inklusive myasthenia gravis, da aminoglycosider kan forværre muskelsvaghed grundet en potentiel curare-lignende virkning på den neuromuskulære funktion.
English: Other information
Danish: Andre oplysninger
English: There are limited data from the parenteral use of tobramycin in pregnant women.
Danish: Der er begrænsede data fra den parenterale anvendelse af tobramycin hos gravide kvinder.
English: In case of a missed dose with at least 6 hours remaining until the next dose, the patient should inhale the dose as soon as possible.
Danish: I tilfælde af en oversprungen dosis med mindst 6 timer tilbage indtil den næste dosis, bør patienten inhalere dosen så snart som muligt.
English: Vantobra is a clear to slightly yellow coloured solution which can vary to a darker yellow.
Danish: Vantobra er en klar til let gulfarvet opløsning, der kan variere til en mørkere gul.
English: Acute toxicity should be treated with immediate withdrawal of Vantobra and baseline tests of renal function should be undertaken.
Danish: Akut toksicitet bør behandles med øjeblikkelig seponering af Vantobra og baseline tests for nyrefunktion bør foretages.
English: PHARMACEUTICAL FORM AND CONTENTS Contains 8 ampoules.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Indeholder 8 ampuller.
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: Mængden af tobramycin udskilt i human modermælk efter administration som inhalation kendes ikke, selvom den skønnes at være meget lav, når man tager den lave systemiske eksponering i betragtning.
English: Urea and creatinine levels should be reassessed after every 6 complete cycles of Vantobra therapy (180 days of nebulised aminoglycoside therapy).
Danish: Urea- og kreatininniveauer bør genvurderes efter hver 6. fuldførte cyklus Vantobra terapi (180 dage med behandling med nebuliseret aminoglycosid).
English: • Risk Management Plan (RMP) The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: There are no data in this population to support a recommendation for or against dose adjustment with Vantobra.
Danish: Der er ingen data om denne population til at understøtte en anbefaling for eller imod dosisjustering af Vantobra.
English: Non-clinical data reveal that the main hazard for humans, based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and development, consists of renal toxicity and ototoxicity.
Danish: Prækliniske data viser, at hovedfaren for mennesker, baseret på konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktionsog udviklingstoksicitet, består af renal toksicitet og ototoksicitet.
English: You should not mix or dilute Vantobra with any other medicine in your Tolero nebuliser handset which is provided together with Vantobra.
Danish: Du bør ikke blande eller fortynde Vantobra med noget andet lægemiddel i dit Tolero nebuliser-håndsæt, som du får sammen med Vantobra.
English: The serum concentration of tobramycin should only be monitored using validated methods.
Danish: Serum-koncentrationen af tobramycin bør kun monitoreres ved brug af validerede metoder.
English: Systemic exposure following inhalation of Vantobra is very low (see section 5.2).
Danish: Systemisk eksponering efter inhalation af Vantobra er meget lav (se pkt.
English: In the absence of conventional susceptibility breakpoints for the nebulised route of administration, caution must be exercised in defining organisms as susceptible or insusceptible to nebulised tobramycin.
Danish: I fravær af breakpoints for konventionel følsomhed for den nebuliserede administrationsvej, skal der udvises forsigtighed ved definering af organismer som følsomme eller ikke-følsomme over for nebuliseret tobramycin.
English: Tobramycin is not metabolised and is primarily excreted unchanged in the urine.
Danish: Tobramycin metaboliseres ikke og udskilles primært uændret i urinen.
English: Tobramycin is an aminoglycoside antibiotic produced by Streptomyces tenebrarius.
Danish: Tobramycin er et aminoglycosid antibiotikum fremstillet af Streptomyces tenebrarius.
English: Ampoules are packed in sachets, one sachet contains 8 ampoules which correspond with 4 days of treatment.
Danish: Ampuller er pakket i breve, hvor ét brev indeholder 8 ampuller, hvilket svarer til 4 dages behandling.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 4.9 Overdose
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: Adequate data do not exist for the use of inhaled tobramycin in patients after organ transplantation.
Danish: Der eksisterer ikke tilstrækkelige data for brugen af inhaleret tobramycin hos patienter efter organtransplantation.
English: P. aeruginosa isolated from CF patients has also been shown to exhibit adaptive aminoglycoside resistance that is characterised by a reversion to susceptibility when the antibiotic is removed.
Danish: P. aeruginosa isoleret fra CF-patienter har også vist sig at udvise adaptiv aminoglycosidresistens, der karakteriseres ved en tilbagevenden til følsomhed, når antibiotikummet fjernes.
English: If there is evidence of therapy-induced bronchospasm, the physician should carefully evaluate whether the benefits of continued use of Vantobra outweighs the risks to the patient.
Danish: Hvis der er tegn på terapi-induceret bronkospasme, bør lægen omhyggeligt evaluere, om fordelene ved fortsat brug af Vantobra opvejer risici for patienten.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppering vises bivirkningsreaktionerne i rækkefølge af faldende alvorlighed.
English: If your underlying lung disease seems to become worse while you are using Vantobra, tell your doctor straight away.
Danish: Hvis din underliggende lungesygdom synes at blive værre, mens du bruger Vantobra, så kontakt straks din læge.
English: PHARMACEUTICAL FORM AND CONTENTS Package contains
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pakningen indeholder
English: Adverse drug reactions reported for tobramycin nebuliser solution are listed in Table 1.
Danish: Bivirkningsreaktioner rapporteret for tobramycin nebuliser-opløsning er angivet i tabel 1.