FrancophonIA/ELRC3.0 huggingface dataset:
English: Glycopyrronium bromide is well established in the EU as a treatment for drooling, and published studies show that it is effective in treating severe drooling in children and adolescents with nervous system conditions which can affect their quality of life.
Danish: Glycopyrroniumbromid er velkendt i EU som behandling for savlen, og publicerede undersøgelser viser, at det virker ved behandling af kraftig savlen hos børn og unge med sygdomme i nervesystemet, der kan påvirke deres livskvalitet.
English: The most common side effects with Sialanar (which may affect more than 1 in 10 people) are irritability, flushing, blocked nose, reduced secretions in the airways, dry mouth, constipation, diarrhoea, vomiting and inability to completely empty the bladder (urinary retention).
Danish: De hyppigste bivirkninger ved Sialanar (der kan forekomme hos mere end 1 ud af 10 personer) er irritabilitet, rødme, tilstoppet næse, nedsat slimproduktion i luftvejene, mundtørhed, forstoppelse, diarré, opkastning og manglende evne til at tømme blæren helt (urinretention).
English: The active substance in Sialanar, glycopyrronium bromide, blocks receptors in the salivary glands known as muscarinic receptors.
Danish: Det aktive stof i Sialanar, glycopyrroniumbromid, blokerer receptorerne i de spytkirtler, der kaldes muskarine receptorer.
English: This study focused on the average final drooling scores after 8 weeks of treatment, which were 1.9 in patients on glycopyrronium bromide and 6.3 in patients on placebo.
Danish: I denne undersøgelse fokuserede forskerne på de gennemsnitlige endelige score for savlen efter 8 ugers behandling, som var 1,9 hos patienter behandlet med glycopyrroniumbromid, og 6,3 hos patienter behandlet med placebo.
English: The second study involved 27 children and adolescents with severe drooling who took either glycopyrronium bromide or placebo for 8 weeks and then had their treatment switched for another 8 weeks.
Danish: I den anden undersøgelse deltog 27 børn og unge med kraftig savlen, som tog enten glycopyrroniumbromid eller placebo i 8 uger, og som derefter skiftede behandling i yderligere 8 uger.
English: For more information about treatment with Sialanar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: De nærmere oplysninger om behandling med Sialanar fremgår af indlægssedlen (også en del af EPAR), eller du kan kontakte din læge eller dit apotek.
English: Two published studies showed that glycopyrronium bromide was effective at reducing drooling in children and adolescents with nervous system conditions, using a standard rating scale known as mTDS (where a score of 1 means no drooling and a score of 9 means profuse drooling).
Danish: To publicerede undersøgelser har vist, at glycopyrroniumbromid effektivt kan reducere savlen hos børn og unge med sygdomme i nervesystemet, ved hjælp af en standard scoreskala, der kaldes mTDS (hvor en score på 1 betyder ingen savlen og en score på 9 betyder kraftig savlen).
English: Sialanar is a medicine for treating severe drooling of saliva in children and adolescents (aged 3 years and above) with conditions affecting the nervous system, such as cerebral palsy, epilepsy and neurodegenerative diseases.
Danish: Sialanar er et lægemiddel til behandling af spytflåd (kraftig savlen) hos børn og unge i alderen 3 år og opefter med sygdomme, der rammer nervesystemet, som f.eks. cerebral parese, epilepsi og neurogenerative sygdomme.
English: Sialanar must not be used in patients with glaucoma (an eye condition), urinary retention, severe kidney impairment or a history of certain intestinal conditions or myasthenia gravis (a condition affecting muscles).
Danish: Sialanar må ikke anvendes til patienter med grøn stær (glaukom, en øjensygdom), urinretention, alvorligt nedsat nyrefunktion eller en sygehistorie med bestemte tarmsygdomme eller en tilstand, hvor musklerne er svækkede (myasthenia gravis).
English: In one of the studies in 38 children and adolescents with severe drooling, around 74% of those taking glycopyrronium bromide after 8 weeks had their scores reduced by 3 points or more compared with 18% of those taking placebo (a dummy treatment).
Danish: I en af undersøgelserne, hvor der deltog 38 børn og unge med kraftig savlen, oplevede 74 % af dem, der tog glycopyrroniumbromid, efter 8 ugers behandling, at deres score blev reduceret med 3 point eller mere i forhold til 18 % af dem, der tog placebo (ikke aktivt stof).
English: For practical information about using Sialanar, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Sialanar, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Sialanar used?
Danish: Hvordan anvendes Sialanar?
English: For the full list of restrictions with Sialanar, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger ved Sialanar fremgår af indlægssedlen.
English: What benefits of Sialanar have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Sialanar?
English: For the full list of all side effects reported with Sialanar, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Sialanar fremgår af indlægssedlen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sialanar have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Sialanar.
English: How does Sialanar work?
Danish: Hvordan virker Sialanar?
English: Elderly patients (≥65 years)
Danish: Ældre patienter (≥ 65 år)
English: • At the request of the European Medicines Agency;
Danish: • på anmodning af Det Europæiske Lægemiddelagentur
English: • Wash your hands thoroughly with soap and water.
Danish: • Vask dine hænder grundigt med vand og sæbe.
English: You then start another course after the break (as illustrated).
Danish: Derefter starter du efter pausen endnu et forløb (som illustreret).
English: Otherwise, wait for your next dose.
Danish: Ellers vent til din næste dosis.
English: Other side effects may include:
Danish: Andre bivirkninger kan omfatte:
English: Tell your doctor as soon as possible.
Danish: Kontakt din læge så snart som muligt.
English: FEV1 should be measured before and after nebulisation.
Danish: FEV1 bør måles før og efter nebulisering.
English: The respective controller can be prescribed by your physician or purchased separately.
Danish: Den respektive controller kan ordineres af din læge eller købes separat.
English: When all of the medicine has been delivered, you will hear the “treatment complete” tone.
Danish: Når al medicinen er blevet afleveret, vil du høre “behandling fuldført” tonen.
English: Duration of treatment
Danish: Varighed af behandlingen
English: Please check this order with your doctor as well.
Danish: Kontrollér også denne rækkefølge med din læge.
English: Warnings and precautions Talk to your doctor if you have ever had any of the following conditions:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, hvis du nogensinde har haft nogen af de følgende tilstande:
English: Some side effects can be serious
Danish: Nogle bivirkninger kan være alvorlige
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1350/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/18/1350/001
English: Patients after organ transplantation
Danish: Patienter efter organtransplantation
English: • The dose is the same for all persons aged 6 years and older.
Danish: • Dosis er den samme for alle personer fra 6 år og opefter.
English: Repeat cycle
Danish: Gentag cyklus
English: In addition, the corresponding frequency category is provided using the following convention: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare
Danish: Derudover gives den tilsvarende hyppighedskategori ved brug af følgende konvention: Meget almindelig (≥ 1/10); Almindelig (≥ 1/100 til < 1/10); Ikke almindelig (≥ 1/1.000 til < 1/100); Sjælden (≥ 1/10.000 til < 1/1.000); Meget sjælden (< 1/10.000).
English: Talk to your doctor if you are concerned about this.
Danish: Tal med din læge, hvis dette bekymrer dig.
English: Never store an opened ampoule.
Danish: Opbevar aldrig en åbnet ampul.
English: • Keep the rest of the medicine refrigerated in the original box.
Danish: • Opbevar resten af medicinen nedkølet i den originale æske.
English: If the product has been stored at room temperature for longer than 4 weeks, it has to be disposed according to local requirements.
Danish: Hvis produktet har været opbevaret ved stuetemperatur i længere end 4 uger, skal det bortskaffes i henhold til lokale krav.
English: Development of resistance
Danish: Udvikling af resistens
English: Hold the nebuliser handset horizontally and breath normally through your mouth.
Danish: Hold nebuliserhåndsættet horisontalt og træk vejret normalt gennem munden.
English: These may still occur while using Vantobra, but should not be as frequent or worse than before.
Danish: Disse kan stadigvæk forekomme under brugen af Vantobra, men skulle ikke være så hyppige eller værre end før.
English: If you don't have a refrigerator available (such as when you are transporting your medicine) you can store the box with the medicine (sachets opened or unopened) below 25°C for up to 4 weeks.
Danish: Hvis du ikke har adgang til et køleskab (såsom når du transporterer din medicin), kan du opbevare æsken med medicin (brevene åbnet eller uåbnet) ved under 25°C i op til 4 uger.
English: Inhalation should be performed by applying a normal breathing pattern without interruption.
Danish: Inhalation bør foretages ved at anvende et normalt åndedrætsmønster uden afbrydelse.
English: ATC code: J01GB01
Danish: ATC-kode: J01GB01
English: If you are taking several different treatments for cystic fibrosis, you should take them in the following order:
Danish: Hvis du tager flere forskellige behandlinger for cystisk fibrose, bør du tage dem i følgende rækkefølge:
English: • The patient should sit in an upright position during inhalation.
Danish: • Patienten bør sidde i en opret stilling under inhalation.
English: • It is best to have an interval as close as possible to 12 hours between doses, but this interval must be at least 6 hours.
Danish: • Det er bedst at have et interval så tæt som muligt på 12 timer mellem doserne, men dette interval skal være mindst 6 timer.
English: No evidence of drug interactions with these medicines was identified.
Danish: Der blev ikke identificeret nogen tegn på lægemiddelinteraktioner med disse lægemidler.
English: • diarrhoea, pain in and around the stomach
Danish: • diarré, smerter i og omkring maven
English: Stability after opening of the sachet: 4 weeks when stored below 25 °C
Danish: Stabilitet efter åbning af brevet: 4 uger ved opbevaring under 25 °C
English: The dose of Vantobra is the same for all patients within the approved age range, regardless of age or weight.
Danish: Dosis af Vantobra er den samme for alle patienter i den godkendte aldersgruppe, uanset alder eller vægt.
English: • generally feeling unwell
Danish: • generel følelse af ikke at have det godt
English: Make sure the nebuliser handset is on a flat, stable surface.
Danish: Kontrollér, at nebuliser-håndsættet er på en flad, stabil overflade.
English: This means that Vantobra may not work as well as it should over time.
Danish: Dette betyder, at Vantobra måske ikke vil fungere så godt som det burde med tiden.
English: Opened ampoule should never be stored for re-use.
Danish: En åbnet ampul må aldrig opbevares for genbrug.
English: Each additional 6 months of treatment resulted in incremental increases similar in magnitude to that observed in the 6 months of controlled studies.
Danish: Hver yderligere 6 måneders behandling resulterede i trinvise øgninger lig i størrelse til de, der blev observeret i de 6-måneders kontrollerede forsøg.
English: Vantobra is taken in alternating cycles of 28 days.
Danish: Vantobra tages i skiftende cyklusser på 28 dage.
English: Adverse drug reactions are listed according to system organ classes in MedDRA.
Danish: Bivirkningsreaktioner er angivet i henhold til systemorganklasser i MedDRA.
English: A package is sufficient for one treatment cycle of 28 days.
Danish: En pakning er tilstrækkelig til en behandlingscyklus på 28 dage.
English: This does not change how Vantobra works provided that the storage instructions have been followed.
Danish: Dette ændrer ikke, hvordan Vantobra fungerer under forudsætning af, at opbevaringsinstruktionerne er blevet fulgt.
English: It works by disrupting the production of proteins that the bacteria need to build their cell walls.
Danish: Det virker ved at afbryde produktionen af proteiner, som bakterierne har brug for til at opbygge deres cellevægge.
English: This damages the bacteria and eventually kills them.
Danish: Dette beskadiger bakterierne og vil med tiden dræbe dem.
English: 82319 Starnberg Germany
Danish: D-82319 Starnberg Tyskland
English: Bronchospasm should be treated as medically appropriate.
Danish: Bronkospasme bør behandles på passende medicinsk måde.
English: Children The medicine is not intended for use in children under 6 years of age.
Danish: Børn Denne medicin er ikke beregnet til brug hos børn under 6 år gamle.
English: If clinical deterioration of pulmonary status is evident, additional or alternative anti-pseudomonal therapy should be considered.
Danish: Hvis klinisk forværring af pulmonær status er tydelig, bør yderligere eller alternativ antipseudomonal behandling overvejes.
English: If the infection is not properly treated, it continues to damage the lungs, causing further problems with breathing.
Danish: Hvis infektionen ikke behandles korrekt, fortsætter den med at beskadige lungerne, hvilket medfører yderligere problemer med vejrtrækningen.
English: Fungal infection Oral candidiasis
Danish: Svampeinfektion Oral candidiasis
English: • Loss of voice
Danish: • tab af stemmen
English: Less than 10% of tobramycin is bound to plasma proteins.
Danish: Mindre end 10 % tobramycin er bundet til plasmaproteiner.
English: Do not use a double dose to make up for a forgotten dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: And this in turn may alter efficacy and safety of the product.
Danish: Og dette kan dermed ændre produktets effekt og sikkerhed.
English: • red pustules, papules on the skin
Danish: • røde blærer, papler på huden
English: • hyperventilating, low oxygen levels in your blood, sinusitis
Danish: • hyperventilering, lave iltniveauer i dit blod, sinusitis
English: Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
Danish: Inden for hver systemorganklasse er bivirkningsreaktionerne rangeret efter hyppighed med de hyppigste reaktioner først.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk -forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: • Begin your treatment sitting in an upright position, in a well ventilated room.
Danish: • Begynd din behandling ved at sidde i en opret position, i et velventileret rum.
English: • After you have used your medicine for 28 days, you then have a 28-day break, during which you do not inhale any Vantobra.
Danish: • Efter at du har brugt din medicin i 28 dage, skal du så have en 28-dages pause, under hvilken du ikke inhalerer noget Vantobra.
English: Continue using Vantobra on this cyclical basis for as long as your doctor tells you.
Danish: Fortsæt med at bruge Vantobra på denne cykliske måde lige så længe, som din læge giver dig besked på.
English: Do not use this medicine if you notice that it has become cloudy, or if there are particles in the solution.
Danish: Brug ikke lægemidlet, hvis du bemærker, at det er blevet uklart, eller hvis der er partikler i opløsningen.
English: Tell your doctor or a pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig, inklusive lægemidler uden recept.
English: People with cystic fibrosis have many symptoms of the disease.
Danish: Mennesker med cystisk fibrose kan have mange symptomer af sygdommen.
English: The recommended dose is two ampoules each day (one in the morning and one in the evening) for 28 days.
Danish: Den sædvanlige dosis er to ampuller hver dag (én om morgenen og én om aftenen) i 28 dage.
English: OFF Vantobra Use Vantobra twice a day for 28 days Do not use any Vantobra for the next 28 days
Danish: Uden Vantobra Brug Vantobra to gange daglig i 28 dage Brug ikke noget Vantobra i de næste 28 dage
English: The dose interval should be as close as possible to 12 hours and not less than 6 hours.
Danish: Doseringsintervallerne bør være så tæt som muligt på 12 timer og ikke under 6 timer.
English: PARI Pharma GmbH Lochhamer Schlag 21 82166 Graefelfing GERMANY
Danish: PARI Pharma GmbH Lochhamer Schlag 21 82166 Graefelfing TYSKLAND
English: The Tolero nebuliser handset can be operated either with an eBase controller or with the eFlow rapid control unit.
Danish: Tolero nebuliser-håndsættet kan betjenes enten med en eBase controller eller med eFlow rapid control unit.
English: If you inhale too much Vantobra you may get a very hoarse voice.
Danish: Hvis du inhalerer for meget Vantobra, kan du få en meget hæs stemme.
English: Do not stop using Vantobra unless your doctor tells you to do so, as your lung infection may not be controlled sufficiently and may become worse.
Danish: Lad være med at holde op med at bruge Vantobra, medmindre din læger siger, at du skal, da din lungeinfektion måske ikke bliver kontrolleret tilstrækkeligt og kan blive værre.
English: Teratogenicity could not be assessed at higher parenteral doses in rabbits as they induced maternal toxicity and abortion.
Danish: Teratogenicitet kunne ikke vurderes ved højere parenterale doser hos kaniner, da de inducerede maternel toksicitet og abort.
English: • furosemide, a diuretic (“water tablet”);
Danish: • Furosemid, et diuretikum (“vanddrivende tablet”)
English: No recommendation for or against dose adjustment can be made for patients after organ transplantation.
Danish: Der kan ikke gives nogen anbefaling for eller mod dosisjustering for patienter efter organtransplantation.
English: • Periodic safety update reports The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler
English: CFU reduction as an indicator for suppression of P. aeruginosa was comparable for Vantobra and the reference product.
Danish: CFU-reduktion som en indikator for suppression af P. aeruginosa var sammenlignelig for Vantobra og referenceproduktet.
English: If you forget to use Vantobra and there are at least 6 hours to your next dose, use your dose as soon as you can.
Danish: Hvis du glemmer at bruge Vantobra, og der er mindst 6 timer til din næste dosis, så tag din dosis så snart du kan.
English: It acts primarily by disrupting protein synthesis leading to altered cell membrane permeability, progressive disruption of the cell envelope and eventual cell death.
Danish: Det virker primært ved at forstyrre proteinsyntesen ledende til ændret permeabilitet af cellemembranen, progressiv forstyrrelse af cellekappen og eventuelt celledød.
English: • If you need to interrupt your treatment for any reason, press and hold the On/Off button for one full second.
Danish: • Hvis du er nødt til at afbryde din behandling af en eller anden grund, så tryk på On/Off knappen og hold den nede ét helt sekund.
English: UNIQUE IDENTIFIER _ HUMAN READABLE DATA PC:
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA PC:
English: It is not known whether inhaling this medicine while you are pregnant causes side effects.
Danish: Det vides ikke, om inhalation af dette lægemiddel under graviditet medfører bivirkninger.
English: • Nebulisation should take place in a well ventilated room.
Danish: • Nebulisering bør finde sted i et velventileret rum.
English: There was no difference in the safety profile between pediatric and adult patient population treated with Vantobra.
Danish: Der var ingen forskel i sikkerhedsprofilen mellem pædiatrisk og voksen patientpopulation behandlet med Vantobra.
English: A cycle of 28 days of active therapy (on-treatment period) and 28 days of rest from treatment (off-treatment period) should be maintained.
Danish: En 28-dages cyklus med aktiv behandling (on-treatment periode) og 28 dages hvile fra behandling (off-treatment periode) bør opretholdes.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products in the nebuliser.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler i nebuliseren.
English: • It is important that you keep using the medicine twice each day during your 28 days on treatment, and that you keep to the 28-day on / 28-day off cycle.
Danish: • Det er vigtigt, at du bliver ved med at bruge medicinen to gange hver dag under dine 28 dage i behandling, og at du overholder 28-dage ”med” / 28-dage ”uden” cyklussen.
English: Finger prick blood sampling is not recommended due to the risk of contamination of the sample.
Danish: Blodprøvetagning med finger-prik anbefales ikke på grund af risikoen for kontaminering af prøven.
English: If you have problems with your hearing or kidney function, your doctor may take blood samples to monitor the amount of Vantobra in your system.
Danish: Hvis du har problemer med din hørelse eller nyrefunktion, kan din læge tage blodprøver for at overvåge mængden af Vantobra i dit system.
English: Based on available data from animals a risk of toxicity (e.g. ototoxicity) at prenatal exposure levels cannot be excluded.
Danish: Baseret på tilgængelige data fra dyr kan en risiko for toksicitet (f.eks. ototoksicitet) ved prænatale eksponeringsniveauer ikke udelukkes.
English: According to current clinical practice baseline renal function should be assessed.
Danish: I henhold til nuværende klinisk praksis bør baseline nyrefunktion vurderes.
English: • other medicines with diuretic potential such as urea or mannitol;
Danish: • Andre lægemidler med diuretisk potentiale, såsom urea eller mannitol
English: Vantobra is a clear to slightly yellow solution, but some variability in colour may be observed, which does not indicate loss of activity if the product is stored as recommended.
Danish: Vantobra er en klar til let gul opløsning, men der kan ses nogen variation i farven, hvilket ikke betyder tab af aktivitet, hvis produktet er opbevaret som anbefalet.
English: You should not take the following medicines while you are using Vantobra:
Danish: Du bør ikke tage følgende lægemidler, mens du bruger Vantobra:
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: Officiel vejledning i korrekt anvendelse af antibakterielle midler bør tages i betragtning.