FrancophonIA/ELRC3.0 huggingface dataset:
English: 4 Press the button firmly all the way in. Do this at least 6 times until it releases a fine mist of spray into the air - see picture f.
Danish: Gør det mindst 6 gange, til der kommer fint forstøvet væske ud i luften - se billede f.
English: 8 Repeat steps 4 to 7 to treat the other nostril.
Danish: Gentag punkt 4-7 i det andet næsebor.
English: It is recommended that the growth of children receiving prolonged treatment with nasal corticosteroids is regularly monitored.
Danish: Det anbefales, at væksten måles jævnligt på børn i langtidsbehandling med nasale kortikosteroider.
English: Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods (see section 4.4).
Danish: Systemiske bivirkninger af nasale kortikosteroider kan forekomme, specielt ved høje doser i længere perioder (se pkt.
English: Mechanism of action: Pharmacotherapeutic group: Nasal preparations, corticosteroids.
Danish: Virkningsmekanisme: Farmakoterapeutisk klassifikation: Nasale præparater, kortikosteroider, ATC-kode: R01AD12
English: Also contains: Glucose anhydrous, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, purified water.
Danish: Indeholder desuden: Vandfrit glukose, dispergibel cellulose, polysorbat 80, benzalkoniumchlorid, dinatriumedetat, renset vand
English: • medicines for asthma
Danish: • astmamedicin
English: Systemic effects of nasal corticosteroid may occur, particularly at high doses prescribed for prolonged periods.
Danish: Systemiske bivirkninger af nasale kortikosteroider kan forekomme, specielt ved høje doser i længere perioder.
English: Systemic effects
Danish: Systemiske bivirkninger
English: Quantifiable levels were observed in 15.1 % of paediatric patients following intranasal dosing of 110 micrograms once daily and only 6.8 % of paediatric patients following 55 micrograms once daily.
Danish: Målbare værdier sås hos < 15,1 % af patienterne efter intranasal administration af 110 mikrogram 1 gang daglig og hos kun < 6,8 % efter en dosis på 55 mikrogram 1 gang daglig.
English: The values are similar to those seen in adults (12+) where median concentrations in those subjects with quantifiable levels were 15.4 pg/ml and 21.8 pg/ml at 55 micrograms and 110 micrograms, respectively.
Danish: Det svarer til de koncentrationer, der ses hos voksne (fra 12 år), hvor middelkoncentrationer, hvor de er målbare, var 15, 4 pg/ml og 21,8 pg/ml ved administration af henholdsvis 55 mikrogram og 110 mikrogram.
English: • The usual starting dose is 1 spray in each nostril once a day.
Danish: • Den sædvanlige startdosis er 1 pust i hvert næsebor 1 gang daglig.
English: But you must be aware that they are potentially serious - so, if you notice any of these symptoms:
Danish: Men du skal være opmærksom på, at de muligvis kan blive alvorlige.
English: In vivo studies have revealed no evidence of cleavage of the furoate moiety to form fluticasone.
Danish: In vivo-forsøg har ikke vist tegn på fraspaltning af furoatdelen, så der dannes fluticason.
English: Always keep the cap on.
Danish: Opbevares altid med hætten på.
English: What you need to know before you use Avamys
Danish: Det skal du vide, før du begynder at bruge Avamys
English: The window in the plastic casing lets you see how much Avamys is left in the bottle.
Danish: I vinduet på siden af næsesprayen kan du se, hvor meget medicin der er tilbage.
English: Increases in posterior subscapsular opacity (0.3 from baseline) were more frequent in subjects treated with fluticasone furoate 110 micrograms [14 (4%)] versus placebo [4 (2%)] and were transient in nature for ten subjects in the fluticasone furoate group and two subjects in the placebo group.
Danish: Stigning i posterior subkapsulær opacitet ( 0,3 fra baseline) var hyppigere hos patienter behandlet med fluticasonfuroat 110 mikrogram [14 (4 %)] i forhold til placebo [4 (2 %)] og var forbigående hos ti i fluticasonfuroat-gruppen og to i placebogruppen.
English: The increase in fluticasone furoate systemic exposure in subjects with moderate hepatic impairment (fluticasone furoate/vilanterol 200/25 micrograms) was associated with an average 34% reduction in serum cortisol compared with healthy subjects.
Danish: Den øgede systemiske eksponering af fluticasonfuroat hos patienter med moderat leverinsufficiens (fluticasonfuroat/vilanterol 200/25 mikrogram) var forbundet med et serumcortisol-niveau, der i gennemsnit var 34 % lavere end hos raske personer.
English: Avamys nasal spray is used to treat symptoms of allergic rhinitis including stuffy, runny or itchy nose, sneezing and watery, itchy or red eyes, in adults and children aged 6 years and over.
Danish: Avamys næsespray anvendes til behandling af symptomer på allergi (sæson- og helårsbetinget), herunder tilstoppet, løbende eller kløende næse, nysen og rindende, kløende eller røde øjne hos voksne og børn fra 6 år.
English: Growth retardation has been reported in children receiving nasal corticosteroids.
Danish: Væksthæmning er indberettet for børn, der har fået nasale kortikosteroider.
English: Growth retardation has been reported in children receiving nasal corticosteroids at licensed doses.
Danish: Væksthæmning er indberettet for børn, der har fået nasale kortikosteroider i anbefalede doser.
English: The medicinal product is available in three pack sizes: 1 bottle of 30, 60 or 120 sprays.
Danish: Der er tre pakningsstørrelser: 1 flaske med 30, 60 eller 120 pust.
English: Do not use Avamys:
Danish: Brug ikke Avamys
English: At weeks 52 and 104, 95% of subjects in both treatment groups had posterior subcapsular opacity values within ± 0.1 of baseline values for each eye and, at week 104, ≤1% of subjects in both treatment groups had 0.3 increase from baseline in posterior subcapsular opacity.
Danish: Ved uge 52 og 104 havde 95 % af patienterne i begge behandlingsgrupper posterior subkapsulær opacitetværdier inden for ± 0,1 for hvert øje i forhold til baseline-værdier.
English: 2 Remove the cap by squeezing firmly on the sides of the cap with your thumb and forefinger- see picture e.
Danish: Fjern hætten ved at klemme hårdt om siderne på den med tommel- og pegefinger - se billede e.
English: There were over 2700 patients treated with fluticasone furoate in safety and efficacy studies for seasonal and perennial allergic rhinitis.
Danish: I sikkerheds- og virkningsstudier blev over 2.700 patienter behandlet med fluticasonfuroat for sæsonbetinget rhinitis og helårsrhinitis.
English: In perennial allergic rhinitis, fluticasone furoate nasal spray 55 micrograms once daily exhibited a more consistent efficacy profile than fluticasone furoate nasal spray 110 micrograms once daily over 4 weeks' treatment.
Danish: Ved allergisk helårsrhinitis viste fluticasonfuroat næsespray 55 mikrogram 1 gang daglig en mere konsistent effekt end fluticasonfuroat næsespray 110 mikrogram 1 gang daglig i en 4 ugers behandling.
English: Fluticasone furoate nasal spray 110 micrograms once daily significantly improved ocular symptoms as well as improving patients' disease-related quality of life (RQLQ) compared to placebo in one study.
Danish: Fluticasonfuroat næsespray 110 mikrogram 1 gang daglig forbedrede signifikant øjensymptomerne og patienternes sygdomsrelaterede livskvalitet (RQLQ) sammenlignet med placebo i et klinisk studie.
English: In seasonal allergic rhinitis, fluticasone furoate nasal spray 110 micrograms once daily was effective but no significant differences were observed between fluticasone furoate nasal spray 55 micrograms once daily and placebo on any endpoint.
Danish: Ved sæsonbetinget allergisk rhinitis var fluticasonfuroat næsespray 110 mikrogram 1 gang daglig virksomt, mens der ikke var signifikant forskel mellem fluticasonfuroat næsespray 55 mikrogram 1 gang daglig og placebo ved nogen af endepunkterne.
English: Some people will not feel the full effects until several days after first using Avamys.
Danish: Nogle mennesker får først maksimal virkning efter flere dages brug, men normalt begynder Avamys at virke i løbet af 8-24 timer.
English: The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Danish: Der bør titreres til laveste dosis, som holder symptomerne under kontrol.
English: The device is primed by pressing the mist release button for at least six spray actuations (until a fine mist is seen), whilst holding the device upright.
Danish: Sprayen klargøres ved, at der affyres mindst 6 pust ved tryk på dosisknappen, mens sprayen holdes lodret.
English: There is a step-by-step guide to using the nasal spray after Section 6 of this leaflet.
Danish: Der er en brugervejledning efter punkt 6 i denne indlægsseddel.
English: Musculoskeletal and connective tissue disorders (Children) Not known
Danish: Perforation af næseskillevæggen Knogler, led, muskler og bindevæv (børn) Ikke kendt
English: study of a single 400 microgram dose of orally inhaled fluticasone furoate in patients with moderate hepatic impairment (Child-Pugh B) resulted in increased Cmax (42 %) and AUC(0-∞) (172 %) and a modest (on average 23 %) decrease in cortisol levels in patients compared to healthy subjects.
Danish: Et studie med en enkelt dosis på 400 mikrogram inhaleret fluticasonfuroat resulterede i øget Cmax (42 %) og AUC(0-∞) (172 %) og et beskedent (gennemsnitlig 23 %) fald i serumcortisol hos patienter med moderat nedsat leverfunktion (Child-Pugh B) sammenlignet med raske frivillige.
English: Other medicines and Avamys
Danish: Brug af anden medicin sammen med Avamys
English: Patients not adequately responding to one spray actuation in each nostril once daily (total daily dose, 55 micrograms) may use two spray actuations in each nostril once daily (total daily dose, 110 micrograms).
Danish: Patienter, der ikke responderer tilstrækkeligt på 1 pust i hvert næsebor 1 gang daglig (døgndosis i alt 55 mikrogram), kan tage 2 pust i hvert næsebor 1 gang daglig (døgndosis i alt 110 mikrogram).
English: • The mist-release button must be pressed firmly all the way in, to release the mist through the nozzle - see picture c.
Danish: • Dosisknappen skal presses hårdt ind for at afgive et pust - se billede c.
English: Do not use Avamys if you are breast feeding unless your doctor or pharmacist tells you to.
Danish: Hvis du ammer, må du ikke bruge Avamys, medmindre lægen eller apoteket siger, at du må.
English: At 110 micrograms, median concentrations in those subjects with quantifiable levels were 14.3 pg/ml and 14.4 pg/ml for 2-5 yrs and 6-11 yrs, respectively.
Danish: Ved 110 mikrogram fluticasonfuroat var middelkoncentrationerne, hvor de var målbare, 14,3 pg/ml hos børn på 2-5 år og 14,4 pg/ml hos børn på 6-11 år.
English: However the dose of intranasal fluticasone furoate should be reduced to the lowest dose at which effective control of the symptoms of rhinitis is maintained.
Danish: Intranasal fluticasonfuroat skal dog altid reduceres til den mindste dosis, hvor symptomerne er under kontrol.
English: Onset of action has been observed as early as 8 hours after initial administration.
Danish: Virkningen kan indtræde allerede 8 timer efter første dosis.
English: If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid if possible, to the lowest dose at which effective control of symptoms is maintained.
Danish: Hvis væksten påvirkes, bør behandlingen revurderes for eventuelt at reduceres til laveste effektive dosis, hvor symptomerne stadig er under kontrol.
English: • Once symptoms are controlled you may be able to decrease your dose to 1 spray in each nostril,
Danish: • Når symptomerne er under kontrol, kan dosis muligvis nedsættes til 1 pust i hvert næsebor 1 gang daglig.
English: Administration of fluticasone furoate to women who are breast-feeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.
Danish: Fluticasonfuroat bør kun anvendes i ammeperioden, hvis fordelene for moderen opvejer de eventuelle risici for barnet.
English: No genotoxic effects of fluticasone furoate have been observed in conventional genotoxicity tests.
Danish: Ved observation i konventionelle genotoksicitetsstudier sås ingen genotoksisk effekt af fluticasonfuroat.
English: Hepatic Impairment No dose adjustment is required in patients with hepatic impairment (see section 5.2).
Danish: Nedsat leverfunktion Dosisjustering er ikke nødvendig til patienter med nedsat leverfunktion (se pkt.
English: Fluticasone furoate is rapidly cleared by extensive first pass metabolism mediated by the cytochrome P450 3A4.
Danish: Interaktion med CYP3A4-hæmmere Der sker en betragtelig first pass-metabolisme af fluticasonfuroat ved hjælp af cytokrom-P450 3A4.
English: • Check the nasal spray for damage
Danish: • Undersøg om næsesprayen er ødelagt.
English: Transient ocular changes (see Clinical experience), vision blurred (see also section 4.4) Respiratory, thoracic and mediastinal disorders Very common
Danish: Forbigående øjenforandringer (se Klinisk erfaring), sløret syn (se også pkt.
English: Median fluticasone furoate concentrations in those subjects with quantifiable levels at 55 micrograms were 18.4 pg/ml and 18.9 pg/ml for 2-5 yrs and 6-11 yrs, respectively.
Danish: Middelkoncentrationerne af fluticasonfuroat, hvor der var målbare koncentrationer ved administration af 55 mikrogram, var 18,4 pg/ml hos børn på 2-5 år og 18,9 pg/ml hos børn på 6-11 år.
English: Safety and efficacy studies were performed in a total of 271 patients from 2 to 5 years of age in both seasonal and perennial allergic rhinitis, of whom 176 were exposed to fluticasone furoate.
Danish: Allergisk sæsonbetinget rhinitis og helårsrhinitis hos børn (under 6 år) Der er lavet sikkerheds- og effektstudier, der omfatter 271 patienter på 2-5 år med både sæsonbetinget rhinitis og helårsrhinitis, hvoraf 176 patienter fik fluticasonfuroat.
English: - If you have any further questions, ask your doctor or pharmacist or nurse.
Danish: Er du i tvivl, så spørg lægen eller på apoteket.
English: Elderly Patients No dose adjustment is required in this population (see section 5.2).
Danish: Ældre patienter Dosisjustering er ikke nødvendig til denne patientgruppe (se pkt.
English: Rhinalgia, nasal discomfort (including nasal burning, nasal irritation, and nasal soreness), nasal dryness.
Danish: Rinalgi, nasalt ubehag (herunder en brændende fornemmelse, irritation og ømhed i næsen), tørhed i næsen
English: Contact a doctor as soon as possible.
Danish: Derfor hvis de opstår: Søg lægehjælp hurtigst muligt.
English: Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria.
Danish: anafylaktisk shock, angioødem, udslæt og urticaria
English: How long Avamys takes to work
Danish: Hvor meget Avamys skal der bruges
English: 3 Hold the nasal spray upright, then tilt and point the nozzle away from you.
Danish: Hold næsesprayen lodret; hæld den derefter let, så næsestudsen peger væk fra dig.
English: The recommended starting dose is two spray actuations (27.5 micrograms of fluticasone furoate per spray actuation) in each nostril once daily (total daily dose, 110 micrograms).
Danish: Den anbefalede initialdosis er 2 pust (27,5 mikrogram fluticasonfuroat/pust) i hvert næsebor 1 gang daglig (døgndosis i alt 110 mikrogram).
English: A reduction in growth velocity has been observed in children treated with fluticasone furoate 110 micrograms daily for one year (see section 4.8 and section 5.1).
Danish: Der er observeret nedsat væksthastighed hos børn behandlet med 110 mikrogram fluticasonfuroat daglig i et år (se pkt.
English: When the cap is in place the mistrelease button cannot be pressed accidentally.
Danish: Når hætten er på, kan der ikke udløses en dosis ved en fejltagelse.
English: Once adequate control of symptoms is achieved, dose reduction to one spray actuation in each nostril once daily (total daily dose, 55 micrograms) is recommended.
Danish: Når symptomerne er under kontrol, anbefales det at reducere vedligeholdelsesdosis til 1 pust i hvert næsebor 1 gang daglig (døgndosis i alt 55 mikrogram).
English: The recommended starting dose is one spray actuation (27.5 micrograms of fluticasone furoate per spray actuation) in each nostril once daily (total daily dose, 55 micrograms).
Danish: Den anbefalede initialdosis er 1 pust (27,5 mikrogram fluticasonfuroat/pust) i hvert næsebor 1 gang daglig (døgndosis i alt 55 mikrogram).
English: Compared with placebo, fluticasone furoate nasal spray 110 micrograms once daily significantly improved nasal symptoms (comprising rhinorrhoea, nasal congestion, sneezing and nasal itching) and ocular symptoms (comprising itching/burning, tearing/watering and redness of the eyes) in all 4 studies.
Danish: Sæsonbetinget allergisk rhinitis hos voksne og unge (fra 12 år) I sammenligning med placebo forbedrede fluticasonfuroat næsespray 110 mikrogram 1 gang daglig signifikant både symptomerne i næsen (rhinorrhoea, tilstoppet næse, nysen og kløe i næse) og i øjnene (kløe/brænden, tåreflåd, konjunktival rødme) i alle fire kliniske studier.
English: Allergy symptoms can occur at specific times of the year and be caused by allergy to pollen from grass or trees (hayfever), or they can occur all year round and be caused by allergy to animals, house-dust mites or moulds to name some of the most common.
Danish: De kan også opstå året rundt på grund af allergi over for dyr, husstøvmider eller skimmelsvamp, for at nævne nogle af de mest almindelige.
English: Repriming (approximately 6 sprays until a fine mist is seen) is only necessary if the cap is left off for 5 days or the intranasal device has not been used for 30 days or more.
Danish: Næsesprayen skal kun klargøres igen, hvis hætten ikke har været på i 5 dage, eller hvis næsesprayen ikke har været anvendt i over en måned.
English: Do not take a double dose to make up for a forgotten dose.
Danish: Hvis det er tæt på næste dosis, skal du vente og tage den. Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: If you use more Avamys than you should Talk to your doctor or pharmacist.
Danish: Hvis du har brugt for meget Avamys Kontakt lægen eller apoteket.
English: As with all intranasal corticosteroids, the total systemic burden of corticosteroids should be considered whenever other forms of corticosteroid treatment are prescribed concurrently.
Danish: Hos patienter, der får anden form for behandling med kortikosteroider, bør der, som med alle intranasale kortikosteroider, ses på den totale mængde af disse.
English: It will damage the nasal spray
Danish: Det ødelægger næsesprayen.
English: The cap keeps the dust out, seals in the pressure and stops the nozzle from blocking up.
Danish: • Næsesprayen skal altid have hætten på, når du ikke bruger den. Hætten holder støv ude, holder på trykket og forhindrer næsestudsen i at blive tilstoppet.
English: AVAMYS 27.5 micrograms/spray, nasal spray suspension
Danish: AVAMYS 27,5 mikrogram/pust, næsespray, suspension
English: Fluticasone furoate nasal spray 110 micrograms once daily significantly improved nasal symptoms as well as patients' perception of overall response to therapy compared to placebo in three studies.
Danish: Allergisk helårsrhinitis hos voksne og unge (fra 12 år) Fluticasonfuroat næsespray 110 mikrogram 1 gang daglig forbedrede signifikant nasalsymptomerne og patienternes opfattelse af det samlede behandlingsrespons sammenlignet med placebo i tre kliniske studier.
English: Headache.
Danish: Hovedpine
English: What the nasal spray looks like
Danish: Næsesprayens udseende
English: These findings are not likely to be relevant for humans given recommended nasal doses which results in minimal systemic exposure.
Danish: De anses ikke for klinisk relevante ved intranasal anvendelse af fluticasonfuroat i de anbefalede doser, hvor den systemiske påvirkning er minimal.
English: What Avamys is and what it is used for What you need to know before you use Avamys How to use Avamys
Danish: Det skal du vide, før du begynder at bruge Avamys Sådan skal du bruge Avamys Bivirkninger
English: How to use the nasal spray
Danish: Sådan skal du bruge næsesprayen
English: Following repeat dosing of orally inhaled fluticasone furoate/vilanterol for 7 days, there was an increase in fluticasone furoate systemic exposure (on average two-fold as measured by AUC(0-24)) in subjects with moderate or severe hepatic impairment (Child-Pugh B or C) compared with healthy subjects.
Danish: Hos patienter med moderat eller svær leverinsufficiens (Child-Pugh B eller C) blev der efter gentagen dosering med oral inhalation af fluticasonfuroat/vilanterol i 7 dage set en stigning i den systemiske eksponering af fluticasonfuroat (gennemsnitligt 2 gange større målt ved AUC(0-24)) sammenlignet med raske frivillige.
English: Each spray delivers 27.5 micrograms of fluticasone furoate.
Danish: Hvert pust afgiver 27,5 mikrogram fluticasonfuroat.
English: The most serious undesirable effects are rare reports of hypersensitivity reactions, including anaphylaxis (less than 1 case per 1000 patients).
Danish: anafylaktisk shock (færre end 1 tilfælde per 1.000 patienter).
English: Cleaning the nasal spray
Danish: Klargøring af næsesprayen
English: The paediatric posology is based on assessment of the efficacy data across the allergic rhinitis population in children.
Danish: Allergisk sæsonbetinget rhinitis og helårsrhinitis hos børn Den anbefalede dosis til børn er baseret på effektdata i studier hos børn med allergisk rhinitis.
English: In animal studies glucocorticoids have been shown to induce malformations including cleft palate and intra-uterine growth retardation.
Danish: I dyrestudier er der påvist abnormiteter som ganespalte og IUGR.
English: Avamys 27.5 micrograms/spray nasal spray suspension Fluticasone furoate
Danish: Avamys 27,5 mikrogram/pust næsespray, suspension Fluticasonfuroat
English: Once adequate control of symptoms is achieved, dose reduction to one spray actuation in each nostril (total daily dose 55 micrograms) may be effective for maintenance.
Danish: Når symptomerne er under kontrol, kan vedligeholdelsesdosis muligvis reduceres til 1 pust i hvert næsebor (døgndosis i alt 55 mikrogram).
English: Fluticasone furoate 110 micrograms once daily was not associated with hypothalamic-pituitary-adrenal (HPA) axis suppression in adult, adolescent or paediatric subjects.
Danish: Hverken hos voksne, unge eller børn førte 110 mikrogram fluticasonfuroat 1 gang daglig til suppression af hypothalamus-hypofyse-binyrebarkfunktionen (HPA).
English: Renal Impairment No dose adjustment is required in this population (see section 5.2).
Danish: Nedsat nyrefunktion Dosisjustering er ikke nødvendig til denne patientgruppe (se pkt.
English: The intranasal device should be shaken before use.
Danish: Næsesprayen omrystes før brug.
English: The device should be cleaned after each use and the cap replaced.
Danish: Næsesprayen skal tørres med en ren og tør klud og hætten sættes på igen efter brug.
English: 7 If your dose is 2 sprays in each nostril repeat steps 4 to 6.
Danish: Gentag punkt 4-6, hvis du skal have 2 pust i hvert næsebor.
English: When to use Avamys
Danish: Hvornår skal Avamys bruges
English: Follow these steps: 1 Shake the nasal spray vigorously with the cap on for about 10 seconds.
Danish: Ryst næsesprayen grundigt i ca. 10 sekunder med hætten på.
English: Check with your doctor or pharmacist if you're not sure.
Danish: - Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er mere, du vil vide.
English: 2 Remove the cap.
Danish: Tag hætten af.
English: How to use Avamys
Danish: Sådan skal du bruge Avamys
English: Manufacturer:
Danish: PRODUKTRESUME
English:  See Step-by-step guide to using the nasal spray, after Section 6.
Danish:  Se brugervejledningen efter punkt 6.
English: Each spray delivers 27.5 micrograms of fluticasone furoate
Danish: Et pust afgiver 27,5 mikrogram fluticasonfuroat
English: What Avamys contains The active substance is fluticasone furoate.
Danish: Aktivt stof: fluticasonfuroat.
English: Uncommon side effects (may affect up to 1 in 100 people) • Pain, burning, irritation, soreness or dryness in the inside of the nose.
Danish: • Smerte, en brændende fornemmelse, irritation, ømhed eller tørhed i næsen.