FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose of nebuliser suspension may need to be diluted in order to obtain a final volume suitable for the particular nebuliser being used, to aid administration of small volumes or if a prolonged delivery time is desirable.
Danish: Det kan være nødvendigt at fortynde dosen af inhalationsvæske til nebulisatoren for at få et endeligt volumen, der er egnet til den bestemte nebulisator, der anvendes, for at gøre det muligt at anvende små volumener eller hvis en længere leveringstid er ønskelig.
English: If growth impairment occurs, the treatment should be assessed with the aim of reducing the dose of inhaled corticosteroid.
Danish: Hvis der er væksthæmning, skal behandlingen vurderes med henblik på at reducere dosis af inhalerede kortikosteroider.
English: Carefully separate a new ampoule from the strip, firstly from the top, then in the middle (Figure B), leaving the rest in the pouch.
Danish: Adskil forsigtigt en ny ampul fra strippen, først fra toppen og derefter i midten (fig. B), idet resten efterlades i posen.
English: It is important, therefore, that the patient is reviewed regularly and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of disease is maintained.
Danish: Det er derfor vigtigt, at patienten revurderes jævnligt, og at dosen af inhaleret kortikosteroid reduceres til den laveste dosis, hvor effektiv kontrol af astma opretholdes.
English: Your doctor will decide if you need a course of corticosteroid tablets or possibly a corticosteroid injection and will also advise you as to how long you need to take the course of corticosteroid tablets and how you should reduce these as you get better.
Danish: Din læge vil beslutte, om du har brug for en kur med steroidtabletter eller muligvis en steroidindsprøjtning og vil også rådgive dig om, hvor længe du skal tage det pågældende antal steroidtabletter og hvordan du kan nedsætte antallet, efterhånden som du får det bedre.
English: Measures to minimize the occurrence of candidiasis, hoarseness and paradoxical bronchospasm are described in section 4.4.
Danish: Foranstaltninger til minimering af forekomsten af candidiasis, hæshed og paradoks bronkospasme er beskrevet i pkt.
English: The absolute bioavailability following inhalation is approximately 2% and 62% of the nominal dose for BDP and B17MP respectively.
Danish: Den absolutte biotilgængelighed efter inhalationen er ca. 2 % og 62 % af den nominelle dosis for henholdsvis BDP og B17MP.
English: Your doctor may decide that your dose should be diluted.
Danish: Din læge kan beslutte, at din dosis skal fortyndes.
English: {INVENTED NAME} should not be injected or administered orally.
Danish: {SÆRNAVN} bør ikke injiceres eller administreres peroralt.
English: The bioavailability of orally administered BDP is negligible but pre-systemic conversion to B17MP results in absorption of approximately 40% of the swallowed portion as B17MP.
Danish: Biotilgængeligheden af oralt administreret BDP er ubetydelig, men præsystemisk konvertering til B17MP resulterer i absorption af ca. 40 % af den slugte del som B17MP.
English: Do not stop treatment with {INVENTED NAME} unless your doctor tells you to.
Danish: Du må ikke ophøre med {SÆRNAVN}, medmindre din læge siger, at du skal.
English: Because growth retardation and damage to the unborn child cannot be excluded upon prolonged treatment with corticosteroids (such as beclometasone dipropionate contained in {INVENTED NAME}) during pregnancy, your doctor will decide whether your disease requires treatment with {INVENTED NAME}.
Danish: Da man ikke kan udelukke væksthæmning og skade på det ufødte barn ved længerevarende behandling med glukokortikoider (såsom beclometasondipropionat, der findes i {SÆRNAVN}) under graviditet, vil din læge beslutte, om din sygdom kræver behandling med {SÆRNAVN}.
English: This affection generally responds to a suitable topical antimycotic therapy, without discontinuing the treatment with beclometasone dipropionate.
Danish: Denne infektionlidelse responderer generelt på en passende topikal antimykotisk behandling, uden at seponere behandlingen med beclometasondipropionat.
English: If no treatment benefit is observed within 2-3 months or if a diagnosis of asthma is not likely, {INVENTED NAME} should be discontinued to avoid unnecessary long-term exposure to inhaled corticosteroids and associated risks in children including growth retardation (see section 4.8).
Danish: Hvis der ikke kan observeres behandlingsfordele inden for 2-3 måneder, eller hvis en diagnose af astma ikke er sandsynlig, bør {SÆRNAVN} seponeres for at undgå unødvendig langvarig eksponering for inhalerede kortikosteroider og associerede risici hos børn, herunder væksthæmning (se afsnit 4.8).
English: Use of {INVENTED NAME} with ultrasonic nebulisers is not recommended because it doesn't allow a correct administration of the medicinal product.
Danish: Det anbefales ikke at anvende {SÆRNAVN} med ultralydsnebulisatorer, fordi de ikke muliggør korrekt administration af lægemidlet.
English: After nebulisation
Danish: Efter nebulisering
English: Beclometasone was teratogenic and embryolethal in animals after, subcutaneous and oral administration.
Danish: Beclometason var teratogent og embryoletalt hos dyr efter subkutan og peroral administration.
English: Growth retardation and behavioural disorders may be more prevalent in children than in adults, particularly at high doses administered for prolonged periods of time.
Danish: Retardering i vækst og adfærdsforstyrrelser kan være hyppigere hos børn end hos voksne, især i høje doser ordineret for lange perioder.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For inhalation use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til inhalation.
English: If your child is below 5 years of age and is receiving prolonged treatment of recurrent wheezing with {INVENTED NAME}, your doctor will regularly monitor his/her height to evaluate if growth impairment occurs and whether to stop the treatment.
Danish: Hvis dit barn er under 5 år, og er i langtidsbehandling med {SÆRNAVN}, vil din læge kontrollere barnets højde regelmæssigt for at vurdere, om dets vækst er hæmmet.
English: Severe exacerbations of asthma must be treated in the normal way, e.g. by increasing the dose of inhaled beclometasone dipropionate and, if necessary, by giving a systemic steroid, and/or an antibiotic if appropriate, and by use of beta 2-agonist therapy.
Danish: Svære forværringer af astmatilstanden skal behandles på normal måde, f.eks. ved at øge dosen af inhaleret beclometasondipropionat og om nødvendigt ved at give en systemisk steroid og/eller et antibiotikum, hvis det er relevant, eller ved at anvende beta2-agonistbehandling.
English: The most common adverse reactions observed during clinical trials using inhaled beclometasone in the treatment of asthma and wheezing were laryngitis, pharyngitis and oral candidiasis.
Danish: De mest almindelige bivirkninger, der er observeret under kliniske forsøg med inhaleret beclometasone i behandling af astma og hvæsende vejrtrækning, er laryngitis, faryngitis og oral candidiasis.
English: However if you experience side effects such as dizziness and/or trembling, your ability to drive or operate machines may be affected.
Danish: Hvis du oplever bivirkninger som f.eks. svimmelhed og/eller rysten, kan din evne til at føre motorkøretøj eller betjene maskiner dog være påvirket.
English: There is insufficient data available regarding the possible growth-inhibiting effect of inhaled corticosteroids in infants and toddlers less than 2 years.
Danish: Der foreligger ikke tilstrækkelige data vedrørende den mulige væksthæmmende virkning hos spædbørn og småbørn under 2 år.
English: As BDP or its metabolites were not traced in urine, an increase in systemic exposure is not envisaged in patients with renal impairment.
Danish: Da der ikke fandtes spor af BDP eller dets metabolitter i urin, regner man ikke med, at der vil forekomme en stigning i systemisk eksponering hos patienter med nedsat nyrefunktion.
English: In case of asthma disease, {INVENTED NAME} must be used regularly on a daily basis.
Danish: I tilfælde af astmasygdom skal {SÆRNAVN} anvendes regelmæssigt på daglig basis.
English: The management of asthma should normally follow a stepwise programme and patient response should be monitored clinically and by lung function tests.
Danish: Behandlingen af astma bør normalt følge et trinvist program, og patientens respons bør overvåges klinisk og ved lungefunktionsprøver.
English: The main product of metabolism is the active metabolite (B17MP).
Danish: Metabolismens hovedprodukt er den aktive metabolit (B17MP).
English: How to use {INVENTED NAME} 4.
Danish: Sådan skal du bruge {SÆRNAVN} 4.
English: Turn on the nebuliser.
Danish: Tænd for nebulisatoren.
English: If you have been taking corticosteroid tablets at high doses or for a long time, your dose may be gradually reduced, approximately one week after you started treatment with {INVENTED NAME}.
Danish: Hvis du i længere tid har taget steroidtabletter i høje doser, kan din dosis reduceres gradvist, ca. én uge efter du begynder behandlingen med {SÆRNAVN}.
English: Increasing use of bronchodilators, in particular short-acting inhaled beta 2-agonists to relieve symptoms indicates deterioration of asthma control.
Danish: Stigende brug af bronkodilatorer, især korttidsvirkende, inhalerede beta2-agonister, til at lindre symptomer, angiver forringet astmakontrol.
English: Other medicines and {INVENTED NAME} Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med {SÆRNAVN} Fortæl lægen eller apotekspersonalet, hvis du tager eller måske vil tage anden medicin eller har gjort det for nylig.
English: In repeat-dose toxicity studies, administration of beclometasone dipropionate by nebulisation to rats (for 180 days) and dogs (for 90 days) had no effect on body weight and blood cells or on trophism of the airways mucosa.
Danish: I toksicitetsstudier med gentagne doser havde administration af beclometasondipropionat ved nebulisering til rotter (i 180 dage) og hunde (i 90 dage) ingen virkning på kropsvægt og blodceller eller på luftvejsslimhindernes tropisme.
English: Damage to the infant is not reported to date.
Danish: Der er dags dato ikke indberettet skader på spædbørn.
English: 4.7 Effects on ability to drive and use machines {INVENTED NAME} has no or negligible influence on the ability to drive or use machines.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner {SÆRNAVN} påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Hypersensitivity reactions with the following manifestations: angioedema, rash, urticaria, pruritus,
Danish: Overfølsomhedsreaktioner med følgende tegn: angioødem, udslæt, urticaria, pruritus
English: In healthy males a single dose of 1600 µg beclometasone dipropionate by nebulisation had no effect on 24-h urinary cortisol excretion, while a single dose of 3200 µg produced a urinary cortisol excretion reduction of about 10% without any significant differences between the two dosage treatments.
Danish: Det er påvist, at hos raske mænd havde en 1600 µg dosis af beclometasondipropionat ved nebulisering ingen virkning på 24-timers kortisoludskillelse i urinen, mens en enkelt dosis på 3200 µg gav en reduktion af ca. 10 % uden nogen signifikant forskel mellem de to dosisbehandlinger.
English: • an allergic reaction (swelling of the eyes, face, lips and throat leading to severe difficulty in breathing, skin rashes, hives, itching or redness)
Danish: • en allergisk reaktion (hævelse af øjne, ansigt, læber og hals, som medfører store vanskeligheder med at ånde, hududslæt, nældefeber, kløe eller rødmen)
English: The 800 micrograms ampoule has a graduation mark to indicate half the content (corresponding to 400 micrograms).
Danish: 800 mikrogram-ampullen har et gradueringsmærke, der angiver halvdelen af indholdet (svarende til 400 mikrogram).
English: Preclinical toxic effects of beclometasone dipropionate were confined to those associated with overstimulation of the recognised pharmacological action.
Danish: Beclometasondiproprionats prækliniske toksiske virkninger er begrænset til dem, der er forbundet med overstimulering af den kendte farmakologiske virkning.
English: BDP is cleared very rapidly from the systemic circulation, by metabolism mediated via esterase enzymes that are found in most tissues.
Danish: BDP's clearance foregår hurtigt fra den systemiske cirkulation ved hjælp af metabolisme medieret via esterase enzymer, som findes i de fleste væv.
English: Store the ampoules in the upright position in the original package (carton box) in order to protect from light.
Danish: Opbevar ampullerne i oprejst position i den oprindelige pakke (papæske) for at beskytte mod lys.
English: What you need to know before you use {INVENTED NAME} 3.
Danish: Det skal du vide, før du begynder at bruge {SÆRNAVN} 3.
English: It is important that you use your dose as advised by your doctor.
Danish: Det er vigtigt, at du bruger den dosis, som lægen har ordineret til dig.
English: Immediately after inhalation the mouth should be rinsed with water to reduce the frequency of fungal infections in the mouth.
Danish: Umiddelbart efter inhalation bør munden skylles med vand for at reducere hyppigheden af svampeinfektioner i munden.
English: During nebulisation
Danish: Under nebulisering
English: If you have been treated for a long time with high doses of inhaled corticosteroid, you may require an extra corticosteroid treatment in times of stress.
Danish: Hvis du i længere tid er blevet behandlet med høje doser af inhaleret steroid, kan du få behov for ekstra steroidbehandling i stressperioder.
English: There is an approximately linear increase in systemic exposure of the active metabolite B17MP with increasing inhaled dose.
Danish: Der er en omtrent lineær stigning i systemisk eksponering af den aktive metabolit B17MP med stigende inhaleret dosis.
English: Infants and neonates born to mothers receiving substantial doses of beclometasone dipropionate during pregnancy should be observed for adrenal suppression.
Danish: Spædbørn og nyfødte, der er født af mødre, som under graviditeten har fået betydelige doser beclometasondipropionat, skal observeres for binyresuppression.
English: In this situation patients should be reassessed and consideration given to the need for increased anti-inflammatory therapy (e.g. higher doses of inhaled corticosteroids or a course of oral corticosteroids).
Danish: I denne situation bør patienter revurderes, og det bør overvejes, om det er nødvendigt at give øget antiinflammatorisk behandling (f.eks. højere doser af inhalerede kortikosteroider eller et behandlingsforløb med orale kortikosteroider).
English: Following inhalation, systemic absorption of unchanged BDP occurs mainly through the lungs with negligible oral absorption of the swallowed dose.
Danish: Efter inhalationen sker den systemiske absorption af uomdannet BDP hovedsagelig gennem lungerne med ubetydelig oral absorption af den slugte dosis.
English: Beclometasone dipropionate demonstrated to be non-genotoxic.
Danish: Det er påvist, at beclometasondipropionat ikke er genotoksisk.
English: {INVENTED NAME} 800 micrograms
Danish: {SÆRNAVN} 800 mikrogram
English: Beclometasone dipropionate undergoes a very rapid pre-systemic metabolism via esterase enzymes without involvement of cytochrome P450 system.
Danish: Beclometasondipropionat gennemgår en meget hurtig præsystemisk metabolisme via esterase enzymer, uden at cytokrom P450-systemet involveres.
English: • throat irritation, hoarse voice
Danish: • irritation i halsen, hæs stemme
English: {INVENTED NAME} 400 micrograms
Danish: {SÆRNAVN} 400 mikrogram
English: For instruction on preparation and dilution of the medicinal product, see section 6.6.
Danish: For instruktioner om tilberedning og fortynding af lægemidlet, se pkt.
English: No evidence of teratogenic effects in pregnant women using inhaled beclometasone was observed according to published data.
Danish: Der er ikke observeret tegn på teratogen effekt hos gravide kvinder, der anvender inhaleret beclometason, i publicerede data.
English: Do not throw away any medicines via wastewater <or household waste>.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet <eller skraldespanden>.
English: What {INVENTED NAME} contains
Danish: {SÆRNAVN} indeholder
English: 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: 4.3 Kontraindikationer Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Throat irritation, hoarseness, dysphonia, paradoxical bronchospasm, wheezing
Danish: Irritation i svælget, dyspnø, paradoksal bronkospasme, hvæsende vejrtrækning
English: Tell your doctor as soon as possible if you suffer from any of these side effects but do not stop treatment unless told to do so.
Danish: Følgende bivirkninger er blevet indberettet: Kontakt din læge hurtigst muligt, hvis du oplever nogen af disse bivirkninger, men du må ikke holde op med behandlingen, medmindre lægen siger, at du skal.
English: Urinary cortisol and the time course of height and weight were unaffected by both treatments and of nebulised beclometasone dipropionate confirmed to have a neutral effect on bone metabolism (Delacourt et al., 2003).
Danish: Urin-kortisol og tidsforløbet for højde og vægt blev ikke påvirket af nogen af behandlingerne, og det blev bekræftet, at nebuliseret beclometasondipropionat har en neutral indvirkning på knoglemetabolismen (Delacourt et al., 2003).
English: The possible benefits of inhaled beclometasone dipropionate for the mother must be weighed against the possible risk for the fetus or neonate.
Danish: De mulige fordele for moderen ved inhaleret beclometasondipropionat skal opvejes mod de mulige risici for fosteret eller den nyfødte.
English: Method of administration {INVENTED NAME} is for inhalation use only.
Danish: Administrationsmetode {SÆRNAVN} er kun beregnet til inhalation.
English: No harmful effects on the suckling infants have been reported for glucocorticoids.
Danish: Der er ikke indberettet skadelig påvirkning af ammede spædbørn for glukokortikoider.
English: Regular nebulised beclometasone dipropionate plus rescue salbutamol significantly increased the percentage of symptom-free days (primary endpoint, defined as a lack of wheezing, coughing, shortness of breath and patients/parents nocturnal awakenings in 24 h) (69.6 ± 20.89 [SD]; P = 0.034) vs placebo/rescue salbutamol (61.0 ± 24.83 [SD]) but not vs combination nebulised beclometasone dipropionate /rescue salbutamol (64.9 ± 24.74 [SD]) regardless of the presence of risk factors for developing asthma.
Danish: Regelmæssig anvendelse af nebuliseret beclometasondipropionat plus anvendelsen af salbutamol som behovsmedicin øgede procentandelen af symptomfrie dage (primært endpoint, defineret som manglende hvæsen, hoste, åndenød og patienters/forældres natlige opvågninger i 24 timer) (69,6 ± 20,89 [SD]; P = 0,034) vs placebo/salbutamol som behovsmedicin (61,0 ± 24,83 [SD]), men ikke vs kombinationen af nebuliseet beclometasondipropionat/salbutamol som behovsmedicin (64,9 ± 24,74 [SD]), uanset tilstedeværelsen af risikofaktorer for udvikling af astma.
English: Such patients should be encouraged to continue treatment with beclometasone dipropionate by inhalation and withdrawal of the systemic corticosteroid, unless objective clinical signs of adrenal impairment are present.
Danish: Sådanne patienter bør opmuntres til at fortsætte behandlingen med beclometasondipropionat ved inhalation og at seponere de systemiske kortikosteroider, medmindre der er objektive, kliniske tegn på binyreinsufficiens.
English: Corticosteroids pass into breast milk at low amounts.
Danish: Kortikosteroider udskilles i modermælk i små mængder.
English: 20 ampoules
Danish: 20 ampuller
English: • maintenance treatment of asthma, when the use of pressurised metered dose or dry powder inhalers is unsatisfactory or inappropriate, in adults and children up to 18 years of age;
Danish: • er indiceret til vedligeholdelsesbehandling af astma, hvor anvendelse af tryk- eller pulverinhalatorer er utilstrækkelig eller uhensigtsmæssig hos voksne og børn op til 18 år;
English: If treatment during pregnancy is necessary, the lowest effective dose of beclometasone dipropionate should be used.
Danish: Hvis behandling undergraviditet er nødvendig, bør den laveste effektive dosis beclometasondipropionat anvendes.
English: • nausea (feeling sick) and stomach pains.
Danish: • kvalme (opkastningsfornemmelser) og mavepine
English: The potency of B17MP is approximately 30-fold higher than the parent compound.
Danish: B17MP er ca. 30 gange stærkere end modersubstansen.
English: In this case, empty the contents of the ampoule into the nebuliser bowl then add the quantity of sterile sodium chloride 9 mg/ml (0.9%) solution that your doctor has told you to use.
Danish: I så fald tømmes enkeltdosisampullens indhold ned i nebulisatorskålen, hvorefter der tilsættes den mængde steril 9 mg/ml (0,9 %) natriumchloridopløsning, som din læge har fortalt dig, at du skal anvende.
English: Minor inactive metabolites, beclometasone-21-monopropionate (B21MP) and beclometasone (BOH), are also formed but these contribute little to the systemic exposure.
Danish: Der dannes også mindre inaktive metabolitter, beclometason-21-monopropionat (B21MP) og beclometason (BOH), men disse bidrager kun lidt til den systemiske eksponering.
English: Reduction or withdrawal of oral corticosteroid therapy may unmask clinical features of Churg-Strauss syndrome and hyper eosinophilic state.
Danish: Reduktion eller seponering af behandling med orale kortikosteroider kan afsløre kliniske symptomer på Churg-Strauss syndrom og hypereosinofil tilstand.
English: The following effects may also occur more likely in children • Sleeping problems, depression or feeling worried, restless, nervous, over-excited or irritable
Danish: Følgende bivirkninger kan også forekomme, men det er mere sandsynligt, at de forekommer hos børn • Søvnproblemer, depression eller angst, rastløshed, nervøsitet, eksaltation eller irritabilitet
English: You can used {INVENTED NAME} 800 micrograms ampoule to get 400 micrograms (half the content) using the graduation mark as described below.
Danish: Du kan bruge {SÆRNAVN} 800 mikrogram for at få 400 mikrogram (halvdelen af indholdet) ved hjælp af målemærket som beskrevet nedenfor.
English: After first opening the pouch, write the date in the box provided on the pouch.
Danish: Første gang folieposen åbnes, skrives datoen på posen i det pågældende felt.
English: {INVENTED NAME} should be administered preferably via jet nebuliser and the compressor equipped with the mouthpiece or suitable face mask.
Danish: {SÆRNAVN} skal helst administreres med en jetnebulisator og kompressor udstyret med mundstykke eller egnet ansigtsmaske.
English: The terminal elimination half-lives are 0.5 h and 2.7 h for BDP and B17MP respectively.
Danish: De terminale eliminationshalveringstider er 0,5 t og 2,7 t for henholdsvis BDP og B17MP.
English: With high doses for a very short period of time, suppression of HPA-axis may occur.
Danish: Anvendelsen af meget højre doser i en meget kort periode kan medføre suppression HPA-aksens funktion.
English: Nebuliser suspension 10 ampoules
Danish: Inhalationsvæske til nebulisator, suspension 10 ampuller
English: {INVENTED NAME} is indicated to treat asthma in adults and children up to 18 years of age when the use of pressurised or dry powder inhalers is unsatisfactory or inappropriate.
Danish: {SÆRNAVN} er indiceret til behandling af astma hos voksne og børn op til 18 år, når brugen af trykregulerede eller pulverinhalatorer er utilfredsstillende eller uhensigtsmæssig.
English: At high doses over a long period of time, {INVENTED NAME} may affect the normal production of corticosteroids in the body.
Danish: Ved langtidsbehandling med høje doser kan {SÆRNAVN} påvirke den normale dannelse af steroider i kroppen.