FrancophonIA/ELRC3.0 huggingface dataset:
English: • Use Vantobra only with the Tolero nebuliser handset shown in the picture below to make sure you inhale the correct dose.
Danish: • Brug kun Vantobra sammen med Tolero nebuliser-håndsættet vist på billedet nedenfor for at sikre, at du inhalerer den korrekte dosis.
English: Patients receiving concomitant parenteral aminoglycoside therapy (or any medicine affecting renal excretion, such as diuretics) should be monitored as clinically appropriate taking into account the risk of cumulative toxicity.
Danish: Patienter, der får samtidig parenteral aminoglycosidbehandling (eller nogen medicin, der påvirker renal udskillelse, såsom diuretika), bør passende monitoreres klinisk, idet der tages højde for risikoen for kumulativ toksicitet.
English: Tinnitus may be a sentinel symptom of ototoxicity, and therefore the onset of this symptom warrants caution.
Danish: Tinnitus kan være et varslende symptom på ototoksicitet, og fremkomst af dette symptom bør derfor berettige til forsigtighed.
English: Concurrent use of Vantobra with diuretic compounds (such as ethacrynic acid, furosemide, urea or mannitol) is not recommended.
Danish: Samtidig anvendelse af Vantobra med diuretiske forbindelser (såsom ethacrynsyre, furosemid, urea eller mannitol) anbefales ikke.
English: Where patients are receiving several inhaled medicinal products and chest physiotherapy, it is recommended that Vantobra is used last.
Danish: Hvor patienter får adskillige inhalerede lægemidler og lungefysioterapi, anbefales det at Vantobra anvendes til sidst.
English: If oto- or nephrotoxicity occurs in a patient receiving Vantobra, tobramycin therapy should be discontinued until serum concentration falls below 2 µg/ml.
Danish: Hvis oto- eller nefrotoksicitet forekommer hos en patient, der får Vantobra, bør behandling med tobramycin seponeres, indtil serum-koncentrationen falder til under 2 µg/ml.
English: Assessment of tobramycin serum concentrations may be helpful in monitoring overdose.
Danish: Vurdering af tobramycin serum-koncentrationer kan være en hjælp ved monitorering af overdosering.
English: • Remove one ampoule of Vantobra from the aluminium foil sachet just before inhalation.
Danish: • Fjern én ampul med Vantobra fra brevet af aluminiumsfolie lige inden inhalationen.
English: Patients with a P. aeruginosa isolate with MIC 128 µg/ml at baseline are less likely to show a clinical response.
Danish: Patienter med en P. aeruginosa isolat med MIC 128 µg/ml ved baseline har mindre sandsynlighed for at vise et klinisk respons.
English: If you are also taking tobramycin or another aminoglycoside antibiotic by injection, it may increase the risk of side effects and your doctor will monitor for these as appropriate.
Danish: Hvis du også tager tobramycin eller andre aminoglycosid antibiotika som injektion, kan det øge risikoen for bivirkninger, og din læge vil om nødvendigt holde øje med disse.
English: • allergic reactions including hives and itching (very rare, affecting up to 1 in 10,000 people).
Danish: • allergiske reaktioner, inklusive nældefeber og kløe (meget sjælden, påvirker op til 1 ud af 10.000
English: Caution should be exercised when prescribing Vantobra to patients with known or suspected renal dysfunction.
Danish: Der bør udvises forsigtighed ved ordination af Vantobra til patienter med kendt eller mistanke om renal dysfunktion.
English: If you experience any of these, stop using Vantobra and tell your doctor straight away.
Danish: Hvis du oplever nogen af disse, så hold op med at bruge Vantobra og kontakt din læge med det samme.
English: The contents of one ampoule should be emptied into the medication reservoir of the Tolero nebuliser handset and administered by inhalation until no medicine is left in the reservoir.
Danish: Indholdet af én ampul skal tømmes ned i medicinreservoiret på Tolero nebuliser-håndsættet og administreres ved inhalation, indtil der ikke er medicin tilbage i reservoiret.
English: The use of an alternative untested nebuliser system may alter the pulmonary deposition of the active substance.
Danish: Brugen af et alternativt, ikke-testet nebuliser-system kan ændre det aktive stofs pulmonære aflejring.
English: In the event of inadvertent administration of Vantobra by the intravenous route, signs and symptoms of parenteral tobramycin overdose may occur, including dizziness, tinnitus, vertigo, loss of hearing acuity, respiratory distress and/or neuromuscular blockage and renal impairment.
Danish: I tilfælde af utilsigtet administration af Vantobra intravenøst, kan tegn og symptomer på parenteral tobramycin overdosering forekomme, inklusive svimmelhed, tinnitus, vertigo, tab af hørelse, åndedrætsbesvær og/eller neuromuskulær blokering og nedsat nyrefunktion.
English: Vestibular toxicity may be manifested by vertigo, ataxia or dizziness.
Danish: Vestibulær toksicitet kan manifestere sig som vertigo, ataxi eller svimmelhed.
English: Such compounds can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue (see section 4.4).
Danish: Sådanne forbindelser kan forstærke aminoglycosid toksicitet ved ændring af antibiotiske koncentrationer i serum og væv (se pkt.
English: Animal studies do not indicate a teratogenic effect of tobramycin (see section 5.3).
Danish: Dyreforsøg indikerer ikke en teratogen effekt af tobramycin (se pkt.
English: It belongs to a class of antibiotic medicines called aminoglycosides.
Danish: Det hører til en klasse af antibiotiske lægemidler, der kaldes aminoglycosider.
English: • other medicines which may harm your kidneys or hearing: o amphotericin B, cefalotin, polymyxins (used to treat microbial infections), ciclosporin, tacrolimus (used to reduce the activity of immune system).
Danish: • Andre lægemidler, som kan gøre skade på dine nyrer eller hørelse: o Amphotericin B, cefalotin, polymyxiner (bruges til at behandle mikrobielle infektioner), ciclosporin, tacrolimus (bruges til at nedsætte immunsystemets aktivitet).
English: The episodes of tinnitus were transient and resolved without discontinuation of tobramycin therapy.
Danish: Episoderne med tinnitus var forbigående og forsvandt uden seponering af behandling med tobramycin.
English: Tobramycin did not impair fertility in male or female rats at subcutaneous doses up to 100 mg/kg/day.
Danish: Tobramycin nedsatte ikke fertilitet hos han- eller hunrotter ved subkutaner doser på op til 100 mg/kg/dag.
English: Following intravenous administration, systemically absorbed tobramycin is eliminated by glomerular filtration.
Danish: Efter intravenøs administration, elimineres systemisk absorberet tobramycin ved glomerulær filtration.
English: UNIQUE IDENTIFIER _ HUMAN READABLE DATA
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA
English: NAME OF THE MARKETING AUTHORISATION HOLDER PARI Pharma GmbH
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN PARI Pharma GmbH
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 Vantobra, taking into account the importance of the treatment to the mother.
Danish: På grund af potentialet for ototoksicitet og nefrotoksicitet hos spædbørn, bør der træffes en beslutning om enten at stoppe amning eller fortsætte behandling med Vantobra, idet vigtigheden af behandlingen af moderen tages i betragning.
English: Inhaling medicines can cause chest tightness due to narrowing of the airways, and this can happen with Vantobra.
Danish: Inhalation af lægemidler kan medføre en stram fornemmelse over brystet på grund af tilsnævring af luftvejene, og dette kan forekomme med Vantobra.
English: One ampoule contains 170 mg of tobramycin as a single dose.
Danish: Én ampul indeholder 170 mg tobramycin som en enkelt dosis.
English: Anorexia
Danish: Anorexi
English: In clinical studies patients using inhaled tobramycin continued to take dornase alfa, bronchodilators, inhaled corticosteroids and macrolides.
Danish: I kliniske forsøg fortsatte patienter, der brugte inhaleret tobramycin, med at tage dornase alfa, bronkodilatatorer, inhalerede kortikosteroider og makrolider.
English: This necessitates sputum concentrations following treatment with aerosolised tobramycin to be ten to twentyfive-fold above the Minimum Inhibitory Concentration (MIC) for both P. aeruginosa growth suppression and control of bactericidal activity.
Danish: Det nødvendiggør spytkoncentrationer efter behandling med aerosoliseret tobramycin at være ti til femogtyve gange over den mindst hæmmende koncentration (MIC) for både P. aeruginosa vækstsuppression og kontrol af baktericid aktivitet.
English: If a patient reports tinnitus or hearing loss during aminoglycoside therapy, the physician should consider referring them for audiological assessment.
Danish: Hvis en patient rapporterer tinnitus eller høretab under behandling med aminoglycosid, bør lægen overveje at henvise dem til audiologisk vurdering.
English: Monitoring of serum tobramycin concentrations
Danish: Monitoring af serum-tobramycinkoncentrationer
English: Vantobra solution is a sterile, aqueous preparation for single use only.
Danish: Vantobra opløsning er et sterilt, vandigt præparat kun til engangsbrug.
English: • ringing in the ears (normally transient), hearing loss, dizziness
Danish: • ringen for ørene (normalt forbigående), høretab, svimmelhed
English: • taste disturbances, feeling sick (nausea), mouth ulcers, being sick (vomiting), loss of appetite
Danish: • smagsforstyrrelser, følen sig syg (kvalme), mundsår, værende syg (opkastning), appetitløshed
English: When they are given by injection, tobramycin and other aminoglycoside antibiotics can cause harm to an unborn child, such as deafness and kidney problems.
Danish: Når de gives som injektion, kan tobramycin og andre aminoglycosid antibiotika medføre skade på det ufødte barn, såsom døvhed og nyreproblemer.
English: If Vantobra is swallowed, it is unlikely to cause severe problems as tobramycin is poorly absorbed from the stomach, but you should still tell your doctor as soon as possible.
Danish: Hvis Vantobra bliver sunket, vil det sandsynligvis ikke medføre større problemer, da tobramycin absorberes dårligt fra maven, men du bør stadigvæk kontakte din læge så snart som muligt.
English: There was no evidence of nephrotoxicity during clinical trials with inhaled tobramycin and Vantobra.
Danish: Der var intet bevis for nefrotoksicitet under klinisk afprøvning med inhaleret tobramycin og Vantobra.
English: Vantobra is supplied in polyethylene (PE) ampoules that are packed in sealed aluminium foil sachets (8 ampoules per sachet).
Danish: Vantobra leveres i polyethylene (PE) ampuller, der er pakket i breve (8 ampuller pr. brev).
English: Vantobra has no or negligible influence on the ability to drive and use machines.
Danish: Vantobra påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: For comparative aerosol data please refer to Table 2 in section 5.1
Danish: For sammenlignelige aerosoldata henvises der til Tabel 2 i pkt.
English: • The Tolero nebuliser handset must be cleaned and disinfected as described in the instructions for use of the device.
Danish: • Tolero nebuliser-håndsættet skal rengøres og desinficeres som beskrevet i anordningens brugsanvisning.
English: If you are breast feeding, you should talk to your doctor before using this medicine.
Danish: Hvis du ammer, bør du tale med din læge, inden du bruger dette lægemiddel.
English: The treatment with Vantobra in patients with active, severe haemoptysis should be initiated only if the benefits of treatment are considered to outweigh the risks of inducing further haemorrhage.
Danish: Behandlingen med Vantobra hos patienter med aktiv, kraftig hæmoptyse bør kun startes op, hvis fordelene ved behandlingen menes at opveje risici for at inducere yderligere blødning.
English: Auditory toxicity, as measured by complaints of hearing loss or by audiometric evaluations, was observed with parenteral aminoglycosides and may be considered also for the inhalation route of administration.
Danish: Auditorisk toksicitet, målt ved klager over høretab eller ved audiometriske evalueringer, blev observeret med parenterale aminoglycosider og skal også tages i betragtning ved inhalation som administrationsmåde.
English: Pharmacotherapeutic group: Antibacterials for systemic use, Aminoglycoside antibacterials.
Danish: Farmakoterapeutisk klassifikation: Antibakterielle midler til systemisk brug, aminoglycosid antibakterielle midler.
English: Unabsorbed tobramycin following administration by inhalation is probably eliminated primarily in expectorated sputum.
Danish: Uabsorberet tobramycin efter administration ved inhalation er sandsynligvis elimineret primært i det ekspektorerede spyt.
English: However, seven of 13 patients (54%) in the placebo-controlled trials who acquired isolates with MICs of 128 µg/ml while using TOBI had improvement in pulmonary function.
Danish: Imidlertid havde syv ud af 13 patienter (54 %) i de placebo-kontrollerede afprøvninger, som opnåede isolater med MIC'er på 128 µg/ml under brug af TOBI, forbedring af lungefunktionen.
English: In patients with a predisposing risk due to previous prolonged systemic aminoglycoside therapy it may be necessary to consider audiological assessment before initiating Vantobra therapy.
Danish: Hos patienter med en prædisponerende risiko grundet tidligere længerevarende behandling med systemisk aminoglycosid, kan det være nødvendigt at overveje audiologisk vurdering inden indledning af behandling med Vantobra.
English: This includes monitoring of serum concentrations of tobramycin.
Danish: Dette omfatter monitorering af serum-koncentrationer af tobramycin.
English: Once opened an ampoule should be used immediately, and any remaining product should be discarded.
Danish: Når den først er åbnet, skal ampullen anvendes med det samme, og tiloversblevet produkt bør kasseres.
English: The most prevalent aminoglycoside resistance mechanism seen in P. aeruginosa isolated from chronically infected CF patients is impermeability, defined by a general lack of susceptibility to all aminoglycosides.
Danish: Den mest fremtrædende aminoglycosid resistensmekanisme set hos P. aeruginosa isoleret fra kronisk inficerede CF-patienter, er impermeabilitet, defineret ved en generel mangel på følsomhed over for alle aminoglycosider.
English: No studies have been performed on patients with hepatic impairment.
Danish: Der er ikke udført nogen forsøg hos patienter med nedsat leverfunktion.
English: • chest pain or general pain
Danish: • brystsmerter eller almene smerter
English: Ototoxicity, manifested as both auditory toxicity (hearing loss) and vestibular toxicity, has been reported with parenteral aminoglycosides.
Danish: Ototoksicitet, manifesteret som både auditorisk toksicitet (høretab) og vestibulær toksicitet, er blevet rapporteret med parenterale aminoglycosider.
English: A clear to slightly yellow solution.
Danish: En klar til let gul opløsning.
English: In controlled clinical trials, 97% of patients receiving tobramycin nebuliser solution achieved sputum concentrations 10-fold of the highest P. aeruginosa MIC cultured from the patient and 95% of patients receiving tobramycin nebuliser solution achieved 25-fold of the highest MIC.
Danish: I kontrollerede kliniske afprøvninger opnåede 97 % af patienterne, der fik tobramycin nebuliseropløsning spytkoncentrationer 10 gange den højeste P. aeruginosa MIC dyrket fra patienten, og 95 % af patienterne, der fik tobramycin nebuliser-opløsning, opnåede 25 gange den højeste MIC.
English: Clinical experience with tobramycin nebuliser solutions reports dysphonia and tinnitus in patients treated with tobramycin.
Danish: Klinisk erfaring med tobramycin nebuliser-opløsninger rapporterer dysfoni og tinnitus hos patienter behandlet med tobramycin.
English: Vantobra contains an antibiotic medicine called tobramycin.
Danish: Vantobra indeholder et antibiotisk lægemiddel, der hedder tobramycin.
English: The performance parameters from in vitro aerosol characterisation studies are identical for the two controllers and are shown in section 5.1, Table 2.
Danish: Parametrene for ydeevne fra in vitro aerosol karakteriseringsstudier er identiske for de to controllere og er vist i pkt.
English: • fungal infections of the mouth or throat, such as thrush
Danish: • svampeinfektioner i munden eller svælget, såsom trøske
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULE
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER AMPUL
English: It is supplied in a box that contains two inner boxes, one with the medicine (56 ampoules with nebuliser solution in 7 sachets), and one with the nebuliser handset.
Danish: Det leveres i en æske, der indeholder to indre æsker, den ene med medicinen (56 ampuller med nebuliser-opløsning i 7 breve), og en med nebuliser håndsættet.
English: The systemic exposure to tobramycin after inhalation of Vantobra is expected to emerge 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 over for tobramycin efter inhalation af Vantobra forventes at fremkomme primært fra den inhalerede del af lægemidlet, da tobramycin ikke absorberes i nogen videre udstrækning, når det gives via den orale vej.
English: Inhalation of nebulised tobramycin produces high sputum concentrations and low plasma levels.
Danish: Inhalation af nebuliseret tobramycin frembringer høje spytkoncentrationer og lave plasmaniveauer.
English: Do not use this medicine after the expiry date which is stated on the ampoule or the sachet or box after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på ampullen, brevet eller æsken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: PHARMACEUTICAL FORM Nebuliser solution.
Danish: LÆGEMIDDELFORM Nebuliser-opløsning.
English: Table 1 Adverse reactions
Danish: Tabel 1 Bivirkningsreaktioner
English: Physicians should consider the potential for aminoglycosides to cause vestibular and cochlear toxicity and carry out appropriate assessments of auditory function during Vantobra therapy.
Danish: Lægerne bør tage potentialet for aminoglycosider til at medføre vestibulær og cochleær toksicitet i betragtning og foretage passende vurderinger af auditorisk funktion under behandling med Vantobra.
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Ototoksicitet
English: Paediatric population There is no relevant use of Vantobra in children below 6 years of age.
Danish: Det er ikke relevant at anvende VANTOBRA hos børn under 6 år.
English: Sputum of cystic fibrosis patients exhibits an inhibitory action on the local biological activity of nebulised aminoglycosides.
Danish: Sputum fra patienter med cystisk fibrose udviser en hæmmende virkning på den lokale, biologiske aktivitet af nebuliserede aminoglycosider.
English: Vantobra is used in patients with cystic fibrosis aged 6 years and older to treat lung infections caused by bacteria named Pseudomonas aeruginosa.
Danish: Vantobra bruges til patienter med cystisk fibrose i alderen fra 6 år og opefter til at behandle lungeinfektioner, der skyldes bakterier, der hedder Pseudomonas aeruginosa.
English: 1 connected with an eBase controller or eFlow rapid controller 2 connected with a PARI Boy SX compressor
Danish: Resultater fra respirationssimulation og kaskadeimpaktormålinger 1 tilsluttet en eBase eller eFlow rapid controller tilsluttet en PARI Boy SX kompressor
English: Empty the contents of one ampoule into the medication reservoir of the nebuliser handset.
Danish: Tøm indholdet af én ampul over i medicinreservoiret på nebuliser-håndsættet.
English: As tobramycin is not metabolised, an effect of hepatic impairment on the exposure to tobramycin is not expected.
Danish: Da tobramycin ikke metaboliseres, forventes der ikke en virkning på nedsat leverfunktion ved eksponering for tobramycin.
English: Vantobra is administered by inhalation using the Tolero nebuliser handset provided in the pack.
Danish: Vantobra administreres som inhalation ved brug af Tolero nebuliser-håndsættet, der leveres i pakningen.
English: Driving and using machines Vantobra is not expected to affect your ability to drive or use machines.
Danish: Vantobra forventes ikke at påvirke evnen til at køre eller bruge maskiner.
English: Lung disorder Chest discomfort Productive cough Rhinitis
Danish: Lungelidelse Ubehag i brystet Produktiv hoste Rhinitis
English: The elimination of tobramycin administered by the inhalation route has not been studied.
Danish: Eliminationen af tobramycin administreret ad inhalationsvejen er ikke blevet undersøgt.
English: In controlled clinical trials with Vantobra the most frequent adverse reactions in cystic fibrosis patients with P. aeruginosa infection were cough and dysphonia.
Danish: I kontrollerede kliniske afprøvninger med Vantobra var de hyppigste bivirkningsreaktioner hos patienter med cystisk fibrose med P. aeruginosa infektion hoste og dysfoni.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each single-dose ampoule of 1.7 ml contains 170 mg tobramycin.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver enkeltdosis ampul med 1,7 ml indeholder 170 mg tobramycin.
English: • ear pain, ear problems
Danish: • øresmerter, øreproblemer
English: At the end of a 4-weeks dosing cycle of Vantobra (170 mg/1.7 ml twice daily) in cystic fibrosis patients, maximum tobramycin plasma concentrations (Cmax) of 1.27 ± 0.81 µg/ml were reached at approximately one hour after inhalation.
Danish: Ved slutningen af en 4-ugers doseringscyklis med Vantobra (170 mg/1,7 ml to gange daglig) hos patienter med cystisk fibrose, nåedes maksimum tobramycin plasmakoncentrationer (Cmaks.)
English: In open label studies and post-marketing experience, some patients with a history of prolonged previous or concomitant use of intravenous aminoglycosides have experienced hearing loss.
Danish: I ublindede forsøg og erfaring efter markedsføring, har nogle patienter med en anamnese for længerevarende tidligere eller samtidig brug af intravenøse aminoglycosider oplevet høretab.
English: The drug delivery rate of Vantobra with the Tolero nebuliser is independent of the breathing pattern applied i.e. adult or child in contrast to the PARI LC PLUS nebuliser.
Danish: Leveringshastigheden for lægemiddel af Vantobra er uafhængig af det anvendte åndedrætsmønster, dvs. voksen eller barn som kontrast til PARI LC PLUS jet nebuliseren.
English: INFORMATION IN BRAILLE Vantobra 170 mg
Danish: INFORMATION I BRAILLESKRIFT Vantobra 170 mg
English: Vantobra is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF).
Danish: Vantobra er indiceret til behandlingen af kronisk lungeinfektion, der skyldes Pseudomonas aeruginosa hos patienter i alderen 6 år og opefter med cystisk fibrose (CF).
English: • Use a new Tolero nebuliser handset for each treatment cycle (28 days on-treatment) as provided with the medicine.
Danish: • Brug et nyt Tolero nebuliser-håndsæt til hver behandlingscyklus (28 dagemed behandling) som medfølger med medicinen.
English: Use a new Tolero nebuliser handset for each treatment cycle (28 days on-treatment) as provided with the medicine.
Danish: Anvend et nyt Tolero nebuliser-håndsæt til hver behandlingscyklus (28 dage med behandling) som leveres sammen med medicinen.
English: Parenteral aminoglycosides have been associated with hypersensitivity, ototoxicity and nephrotoxicity (see section 4.4).
Danish: Parenterale aminoglycosider er blevet sat i forbindelse med overfølsomhed, ototoksicitet og nefrotoksicitet (se pkt.
English: In clinical studies with TOBI, most patients with P. aeruginosa isolates with tobramycin MICs < 128 µg/ml at baseline showed improved lung function following treatment with TOBI.
Danish: I kliniske forsøg med TOBI viste de fleste patienter med P. aeruginosa isolater med tobramycin MIC'er < 128 µg/ml ved baseline forbedret lungefunktion efter behandling med TOBI.