FrancophonIA/ELRC3.0 huggingface dataset:
English: • Nasal ulceration - which may cause irritation or discomfort in your nose.
Danish: • Sår i næsen - hvilket kan give irritation og ubehag i næsen.
English: Children 6 to 11 years
Danish: Børn 6-11 år
English: Glucose anhydrous Dispersible cellulose Polysorbate 80
Danish: Vandfrit glucose Dispergibel cellulose Polysorbat 80
English: Avamys (fluticasone furoate) belongs to a group of medicines called glucocorticoids.
Danish: Avamys (fluticasonfuroat) tilhører en gruppe af lægemidler, som hedder binyrebarkhormoner.
English: The most commonly reported adverse reactions during treatment with fluticasone furoate are epistaxis, nasal ulceration and headache.
Danish: De hyppigst indberettede bivirkninger ved behandling med fluticasonfuroat er epistaxis, nasale ulcerationer og hovedpine.
English: If there is any reason to believe that adrenal function is impaired, care must be taken when transferring patients from systemic steroid treatment to fluticasone furoate.
Danish: Hvis der er grund til at tro, at binyrebarkfunktionen er nedsat, skal der udvises forsigtighed ved behandlingsskift fra systemiske steroider til fluticasonfuroat.
English: The mean treatment difference was -0.27 cm per year [95% CI -0.48 to -0.06].
Danish: Den gennemsnitlige forskel var -0,27 cm/år (95 % konfidensinterval -0,48 til -0,06).
English: Increases in posterior subcapsular opacity or IOP were not accompanied by any adverse events of cataracts or glaucoma.
Danish: Stigning i posterior subkapsulær opacitet eller IOP var ikke ledsaget af bivirkninger som grå stær eller glaukom.
English: Fluticasone furoate is a synthetic trifluorinated corticosteroid that possesses a very high affinity for the glucocorticoid receptor and has a potent anti-inflammatory action.
Danish: Fluticasonfuroat er et syntetisk trifluorineret kortikosteroid med meget høj affinitet for kortikosteroidreceptoren og potent antiinflammatorisk virkning.
English: If you need to check how much is left hold the nasal spray upright against a bright light.
Danish: Hvis du har brug for at vide, hvor meget der er tilbage, hold da flasken lodret op imod lyset.
English: There was no evidence for higher quantifiable levels of fluticasone furoate in younger children (less than 6 years of age).
Danish: Der var ingen tegn på en større forekomst af målbare værdier af fluticasonfuroat hos mindre børn (under 6 år).
English: The nasal spray comes in an amber glass bottle inside a plastic casing - see picture a. It will contain either 30, 60 or 120 sprays, depending on the pack size that has been prescribed for you.
Danish: Medicinen er i en brun glasflaske i en kappe af plastik - se billede a. Den indeholder enten 30, 60 eller 120 pust, alt efter hvilken pakningsstørrelse der er blevet ordineret.
English: Avamys nasal spray should be used within 2 months after first opening.
Danish: Avamys næsespray skal bruges senest to måneder efter flasken blev åbnet første gang.
English: The duration of treatment should be restricted to the period that corresponds to allergenic exposure.
Danish: Behandlingen bør kun finde sted i den periode, patienten udsættes for allergeneksposition.
English: The intranasal dosing of 110 micrograms once daily does not typically result in measurable plasma concentrations (<10 pg/ml).
Danish: Intranasal administration af 110 mikrogram om dagen resulterer ikke typisk i målbare plasmakoncentrationer (< 10 pg/ml).
English: Elimination was primarily via the faecal route following oral and intravenous administration indicative of excretion of fluticasone furoate and its metabolites via the bile.
Danish: Eliminationen skete primært via fæces efter oral og intravenøs administration, hvilket tyder på udskillelse af fluticasonfuroat og dets metabolitter med galden.
English: Breast-feeding It is unknown whether nasal administered fluticasone furoate is excreted in human breast milk.
Danish: Det vides ikke, om nasalt administreret fluticasonfuroat udskilles i human mælk.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Mean growth velocity over the 52-week treatment period was lower in the patients receiving fluticasone furoate (5.19 cm/year) compared to placebo (5.46 cm/year).
Danish: Den gennemsnitlige væksthastighed i løbet af en behandlingsperiode på 52 uger var lavere hos patienter, der fik fluticasonfuroat (5,19 cm/år), sammenlignet med placebo (5,46 cm/år).
English: If there is evidence for higher than recommended doses being used, then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Danish: Hvis der anvendes højere doser end de anbefalede, skal det overvejes at give supplerende, systemiske kortikosteroider i stressperioder eller ved kirurgi.
English: Treatment with higher than recommended doses of nasal corticosteroids may result in clinically significant adrenal suppression.
Danish: Behandling med højere doser nasale kortikosteroider end de anbefalede kan resultere i klinisk signifikant binyrebarksuppression.
English: 30 sprays 60 sprays 120 sprays
Danish: 30 pust 60 pust 120 pust
English: Potential systemic effects may include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
Danish: Eventuel systemisk virkning kan omfatte Cushings syndrom, cushingoide træk, binyrebarksuppression, væksthæmning hos børn og unge, katarakt, glaukom og sjældnere en række psykiske og adfærdsrelaterede virkninger, inklusive psykomotorisk hyperaktivitet, søvnforstyrrelser, angst, depression eller aggression (specielt hos børn).
English: Therefore, no clinical studies have been conducted to investigate interactions of fluticasone furoate on other drugs.
Danish: Der er derfor ikke gennemført kliniske studier med det formål at undersøge interaktioner mellem fluticasonfuroat og andre lægemidler.
English: • If symptoms are very bad your doctor may increase the dose to 2 sprays in each nostril once every day until the symptoms are under control.
Danish: • Hvis symptomerne er meget voldsomme, kan lægen øge dosis til 2 pust i hvert næsebor 1 gang daglig, indtil symptomerne igen er under kontrol.
English: You will then be able to see the level through the window.
Danish: Man kan se indholdet gennem et vindue.
English: Only a small number of elderly patients (≥ 65 years, n=23/872; 2.6 %) provided pharmacokinetic data.
Danish: Der findes kun farmakokinetiske data for et mindre antal ældre (≥ 65 år, n = 23/872; 2,6 %).
English: Fluticasone furoate is rapidly cleared (total plasma clearance of 58.7 l/h) from systemic circulation principally by hepatic metabolism to an inactive 17β-carboxylic metabolite (GW694301X), by the cytochrome P450 enzyme CYP3A4.
Danish: Fluticasonfuroat udskilles hurtigt (samlet plasma-clearance på 58,7 l/t) fra det systemiske kredsløb hovedsageligt via leveren til en inaktiv 17β-karboxylmetabolit (GW694301X) ved hjælp af cytokrom P450-enzym CYP3A4.
English: Nasal corticosteroids can affect the normal production of hormones in your body, particularly if you use high doses for a long time.
Danish: Brug af binyrebarkhormoner i næsen kan påvirke den naturlige hormonproduktion i kroppen, især hvis du bruger høje doser i lang tid.
English: Avamys is available in pack sizes 30, 60 and 120 sprays.
Danish: Avamys fås i pakninger med 30, 60 og 120 pust.
English: • steroid tablets or injected steroids
Danish: • steroider (som tabletter eller injektioner)
English: The principal route of metabolism was hydrolysis of the Sfluoromethyl carbothioate function to form the 17β-carboxylic acid metabolite.
Danish: Primært foregår metabolismen ved hydrolyse af S-fluorometylkarbotioatfunktionen for at danne 17β-karboxylsyremetabolitten.
English: Adults and adolescents (12 years and over)
Danish: Voksne og unge (fra 12 år)
English: Do not use Avamys if you are pregnant, or planning to become pregnant, unless your doctor or pharmacist tells you to.
Danish: Du må ikke bruge Avamys, hvis du er gravid eller har planer om at blive det, medmindre lægen eller apoteket siger, at du må.
English: The enzyme induction and inhibition data suggest that there is no theoretical basis for anticipating metabolic interactions between fluticasone furoate and the cytochrome P450 mediated metabolism of other compounds at clinically relevant intranasal doses.
Danish: Ud fra data om enzyminduktion og -inhibition er der ikke teoretisk grundlag for at forvente metaboliske interaktioner mellem fluticasonfuroat og cytokrom-P450-medieret metabolisme af andre stoffer ved klinisk relevante intranasale doser.
English: In a bioavailability study, intranasal doses of up to 2640 micrograms per day were administered over three days with no adverse systemic reactions observed (see section 5.2).
Danish: I et biotilgængelighedsforsøg blev der givet intranasale doser på op til 2640 mikrogram om dagen i 3 dage uden systemiske bivirkninger (se pkt.
English: • When you first use the nasal spray you will need to shake it vigorously with the cap on for about 10 seconds.
Danish: • Første gang du bruger næsesprayen, skal den rystes omhyggeligt i ca. 10 sekunder med hætten på.
English: Children (6 to 11 years of age)
Danish: Børn (6-11 år)
English: A randomised, double-blind, parallel-group, multicenter, one-year placebo-controlled clinical growth study evaluated the effect of fluticasone furoate nasal spray 110 micrograms daily on growth velocity in 474 prepubescent children (5 to 7.5 years of age for girls and 5 to 8.5 years of age for boys) with stadiometry.
Danish: Et randomiseret, dobbeltblindet, parallelgruppe, multicenter, etårigt placebokontrolleret klinisk studie af vækst evaluerede virkningen af fluticasonfuroat-næsespray 110 mikrogram daglig på væksthastigheden hos 474 præpubertale børn (5-7,5 år for piger og 5-8,5 år for drenge) med stadiometer.
English: This helps to get the medicine to the correct part of your nose.
Danish: På den måde fordeles medicinen bedst i næsen.
English: 1 Wipe the nozzle and inside of the cap with a clean, dry tissue - see pictures i and j.
Danish: Tør næsestudsen og indersiden af hætten med en tør, ren klud - se billede i og j.
English: Paediatric exposure to fluticasone furoate in safety and efficacy studies in seasonal and perennial allergic rhinitis included 243 patients 12 to <18 years, 790 patients 6 to <12 years and 241 patients 2 to <6 years.
Danish: Pædiatrisk eksponering for fluticasonfuroat i sikkerheds- og virkningsstudier af sæsonbetinget rhinitis og helårsrhinitis omfattede 243 patienter i alderen 12 til <18 år, 790 patienter i alderen 6 til <12 år og 241 patienter i alderen 2 til <6 år.
English: • ketoconazole, used to treat fungal infections
Danish: • ketoconazol (medicin mod svampeinfektioner)
English: • If it is still not working, or if it produces a jet of liquid, take the nasal spray back to the pharmacy to get advice.
Danish: • Hvis den stadig ikke virker, eller hvis væsken kommer ud som en stråle, så tal med apoteket om det.
English: Based on these findings the average predicted exposure of 110 micrograms of intranasal fluticasone furoate in this patient population would not be expected to result in suppression of cortisol.
Danish: På baggrund af disse fund forventes en gennemsnitlig optagelse fra 110 mikrogram intranasalt fluticasonfuroat til denne patientpopulation ikke at resultere i suppression af binyrebarkfunktionen.
English: If you forget to use Avamys If you miss a dose, take it when you remember.
Danish: Hvis du har glemt en dosis, skal du tage den, når du kommer i tanke om det.
English: The medicine is a white nasal spray suspension contained in an amber glass bottle, fitted with a pump.
Danish: Medicinen er en hvid suspension i brun glasflaske med pumpefunktion.
English: 5 Press the button firmly all the way in, while you breathe in through your nose - see picture h.
Danish: Tryk dosisknappen hårdt ind, mens du trækker vejret ind gennem næsen - se billede h.
English: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations) Harmire Road
Danish: Glaxo Operations UK Ltd (Glaxo Wellcome Operations) Harmire Road
English: Preparing the nasal spray helps to make sure you always get the full dose of medicine.
Danish: Når du klargør næsesprayen før brug, er det med til at sikre, at du får en fuld dosis hver gang.
English: Fluticasone furoate is not detectable in urine from healthy volunteers after intranasal dosing.
Danish: Fluticasonfuroat kan ikke spores i urin fra raske frivillige efter intranasal administration.
English: There was no effect on serum cortisol in subjects with severe hepatic impairment (fluticasone furoate/vilanterol 100/12.5 micrograms).
Danish: Der var ingen påvirkning af serumkortisol hos personer med svær leverinsufficiens (fluticasonfuroat/vilanterol 100/12,5 mikrogram).
English: Very rare side effects (may affect up to 1 in 10,000 people) • Small holes (perforations) in the ridge inside the nose that separates the nostrils.
Danish: Meget sjældne bivirkninger (kan forekomme hos op til 1 ud af 10.000 personer) • Små huller (perforeringer) i næsens skillevæg.
English: You must prepare the nasal spray:
Danish: Du skal klargøre næsesprayen:
English: 3 Blow your nose to clear your nostrils, then tilt your head forward a little bit.
Danish: Puds næse, så der er fri passage i næsen, og bøj hovedet lidt forover.
English: EXPIn-use shelf life: 2 months
Danish: EXP Efter anbrud: 2 måneder
English: These events were transient in nature for six subjects in the fluticasone furoate group and one placebo subject.
Danish: Denne bivirkning var forbigående hos seks personer i fluticasonfuroat-gruppen og hos en person i placebogruppen.
English: Avamys works to decrease inflammation caused by allergy (rhinitis) and therefore reduce symptoms of allergy.
Danish: Avamys virker ved at nedsætte inflammation (en betændelsesagtig tilstand) i næsen og irritation i øjnene forårsaget af allergi (rhinitis) og reducerer derfor symptomerne på allergi.
English: DL12 8DT
Danish: County Durham DL12 8DT
English: • may when taken for a long time cause children to grow more slowly.
Danish: • kan være årsag til langsommere vækst hos børn, hvis de får det i lang tid.
English: Growth retardation **In a one-year clinical study assessing growth in pre-pubescent children receiving 110 micrograms of fluticasone furoate once daily, an average treatment difference of -0.27 cm per year in growth velocity was observed compared to placebo (see Clinical efficacy and safety).
Danish: Væksthæmning ** I et 1 års klinisk studie, der undersøgte væksten hos præpubertale børn, der fik 110 mikrogram fluticasonfuroat 1 gang daglig, blev der observeret en gennemsnitlig forskel på -0,27 cm om året i væksthastigheden ved behandling sammenlignet med placebo (se Klinisk virkning og sikkerhed).
English: • before you use it for the first time • if you have left the cap off for 5 days or the intranasal device has not been used for 30 days or more.
Danish: • Hvis hætten ikke har været på i 5 dage, eller hvis næsesprayen ikke har været anvendt i 30 dage eller mere.
English: 14.2 ml Type I or Type III amber bottle (glass) fitted with a metering spray pump.
Danish: 14,2 ml brun glasflaske (type I eller type III) med doseringspumpe.
English: 3 Never use a pin or anything sharp on the nozzle.
Danish: Brug aldrig en nål eller noget skarpt i næsestudsen.
English: Increases in IOP (7 mmHg from baseline) were more frequent in subjects treated with fluticasone furoate 110 micrograms: 7 (2%) for fluticasone furoate 110 micrograms once daily and 1 (<1%) for placebo.
Danish: Stigning i IOP ( 7 mmHg fra baseline) var hyppigere hos patienter behandlet med fluticasonfuroat 110 mikrogram: 7 (2 %) for fluticasonfuroat 110 mikrogram 1 gang daglig og 1(< 1 %) for placebo.
English: Symptoms include: - becoming very wheezy, coughing or having difficulty with breathing - suddenly feeling weak or light-headed (which may lead to collapse or loss of consciousness) - swelling around the face - skin rashes or redness.
Danish: Symptomerne kan være: - meget hvæsende vejrtrækning, hoste eller vejrtrækningsbesvær - pludselig fornemmelse af svaghed eller svimmelhed (der kan føre til kollaps eller bevidstløshed) - hævelse i ansigtet - udslæt eller rødme
English: Fluticasone furoate undergoes incomplete absorption and extensive first-pass metabolism in the liver and gut resulting in negligible systemic exposure.
Danish: Fluticasonfuroat absorberes ufuldstændigt, og omfattende first-pass metabolisme i lever og tarm resulterer i negligeabel systemisk påvirkning.
English: Fluticasone furoate nasal spray significantly improved the patients' perception of overall response to therapy, and the patients' disease-related quality of life (Rhinoconjunctivitis Quality of Life Questionnaire - RQLQ), in all 4 studies.
Danish: Fluticasonfuroat næsespray forbedrede signifikant både patienternes opfattelse af det samlede behandlingsrespons og deres sygdomsrelaterede livskvalitet (”Rhinoconjunctivitis Quality of Life Questionnaire - RQLQ") i alle fire kliniske studier.
English: Based on data with another glucocorticoid (fluticasone propionate), that is metabolised by CYP3A4, coadministration with ritonavir is not recommended because of the risk of increased systemic exposure of fluticasone furoate.
Danish: På baggrund af data fra et andet kortikosteroid (fluticasonpropionat), som metaboliseres af CYP3A4, bør ritonavir ikke gives samtidig på grund af risikoen for øget systemisk påvirkning af fluticasonfuroat.
English: Avamys nasal spray is for administration by the intranasal route only.
Danish: Avamys næsespray er kun til intranasal anvendelse.
English: Therefore, children should be maintained on the lowest possible efficacious dose which delivers adequate symptom control (see section 4.2).
Danish: Vedligeholdelsesdosis til børn skal derfor være den lavest mulige dosis, som giver tilstrækkelig symptomkontrol (se pkt.
English: Data are available following inhaled administration of fluticasone furoate (as fluticasone furoate or fluticasone furoate/vilanterol) to subjects with hepatic impairment that are also applicable for intranasal dosing.
Danish: Der foreligger data efter inhalation af fluticasonfuroat (som fluticasonfuroat eller fluticasonfuroat/vilanterol) hos patienter med nedsat leverfunktion, som også er anvendelige ved intranasal administration.
English: This is not likely to be relevant for humans given recommended nasal doses which results in minimal systemic exposure (see section 5.2).
Danish: Dette er ikke sandsynligt hos mennesker ved de anbefalede doser, der kun fører til minimal systemisk påvirkning (se pkt.
English: The other ingredients are glucose anhydrous, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, purified water (see section 2).
Danish: Øvrige indholdsstoffer: vandfrit glucose, dispergibel cellulose, polysorbat 80, benzalkoniumchlorid, dinatriumedetat, renset vand (se punkt 2).
English: In a drug interaction study of intranasal fluticasone furoate with the potent CYP3A4 inhibitor ketoconazole there were more subjects with measurable fluticasone furoate concentrations in the ketoconazole group (6 of the 20 subjects) compared to placebo (1 out of 20 subjects).
Danish: I en interaktionsundersøgelse, hvor fluticasonfuroat blev givet samtidig med den potente CYP3A4hæmmer ketoconazol, var koncentrationen af fluticasonpropionat målbar hos flere i gruppen, der fik ketoconazol (hos 6 ud af 20), sammenlignet med placebogruppen (hos 1 ud af 20).
English: Concomitant administration with ritonavir is not recommended because of the risk of increased systemic exposure of fluticasone furoate (see section 4.5).
Danish: Samtidig brug af ritonavir bør ikke finde sted på grund af risiko for øget systemisk påvirkning af fluticasonfuroat (se pkt.
English: In a two-year study designed to assess the ocular safety of fluticasone furoate (110 micrograms once daily intranasal spray), adults and adolescents with perennial allergic rhinitis received either fluticasone furoate (n=367) or placebo (n=181).
Danish: I et to-årigt studie, designet til at vurdere den okulære sikkerhed af fluticasonfuroat (110 mikrogram 1 gang daglig som næsespray), fik voksne og unge med allergisk helårsrhinitis enten fluticasonfuroat (n = 367) eller placebo (n = 181).
English: Never pass it on to others.
Danish: Lad derfor være med at give medicinen til andre.
English: In the majority of patients fluticasone furoate is not quantifiable (< 10 pg/ml) following intranasal dosing of 110 micrograms once daily.
Danish: Hos hovedparten af de pædiatriske patienter kan fluticasonfuroat ikke måles (< 10 pg/ml) efter intranasal administration af 110 mikrogram 1 gang daglig.
English: • Never use a pin or anything sharp to clear the nozzle.
Danish: • Brug aldrig en nål eller et skarpt instrument til at forsøge at få hul igennem næsestudsen.
English: For full therapeutic benefit regular, scheduled usage is recommended.
Danish: Regelmæssig fast behandling anbefales for at opnå fuld effekt.
English: Taking Avamys:
Danish: Avamys indeholder:
English: The absolute bioavailability for intranasal fluticasone furoate is 0.50 %, such that less than 1 microgram of fluticasone furoate would be systemically available after administration of 110 micrograms (see section 4.9).
Danish: Den absolutte biotilgængelighed af intranasal fluticasonfuorat er 0,50 %, dvs. at den systemiske tilgængelighed er mindre end 1 mikrogram fluticasonfuroat efter administration af 110 mikrogram (se pkt.
English: Efficacy was maintained over the full 24-hours dosing period with once daily administration.
Danish: Effekten varede hele døgnet med administration 1 gang daglig.
English: The safety and efficacy of Avamys in children under the age of 6 years has not been established.
Danish: Avamys's sikkerhed og virkning hos børn under 6 år er ikke klarlagt.
English: A 6-week study that assessed the effect of fluticasone furoate nasal spray 110 micrograms once daily on adrenal function in children aged 2 to 11 years showed that there was no significant effect on 24-hour serum cortisol profiles, compared with placebo.
Danish: Et 6 ugers studie, hvor man vurderede virkningen af fluticasonfuroat næsespray 110 mikrogram 1 gang daglig på binyrebarkfunktionen hos børn i alderen 2-11 år, viste ingen signifikant forskel på 24 timers serumkortisolniveauet sammenlignet med placebo.
English: 4 Place the nozzle in one of your nostrils - see picture g. Point the end of the nozzle slightly outwards, away from the centre ridge of your nose.
Danish: Før næsestudsen ind i det ene næsebor - se billede g. Hold næsestudsen, så den peger lidt ud mod næsens yderside, væk fra næseskillevæggen.
English: There are no data with intranasal fluticasone furoate in patients with hepatic impairment.
Danish: Der findes ingen oplysninger om intranasal fluticasonfuroat hos patienter med nedsat leverfunktion.
English: Caution is recommended when co-administering fluticasone furoate with potent CYP3A inhibitors including cobicistat-containing products as an increase in the risk of systemic side effects is expected.
Danish: Forsigtighed tilrådes ved samtidig behandling med potente CYP3A4-hæmmere, herunder produkter der indeholder cobicistat, da en øget risiko for systemiske bivirkninger forventes.
English: Be careful not to get any spray into your eyes.
Danish: Undgå at få medicinen i øjnene.
English: Benzalkonium chloride Disodium edetate Purified water
Danish: Benzalkoniumchlorid Dinatriumedetat Renset vand
English: There was no evidence for a higher incidence of patients with quantifiable fluticasone furoate concentrations in the elderly, when compared with the younger patients.
Danish: Der var ikke tegn på større forekomst med målbare koncentrationer af fluticasonfuroat hos ældre end hos yngre.
English: The bottle is in an off-white plastic casing with a light blue cap and side-actuated lever.
Danish: Flasken er i en råhvid plastickappe med lyseblå hætte og dosisknap på siden.