FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, consideration should be given to referring the patient to a paediatric specialist (see section 5.1).
Danish: Det bør desuden overvejes at henvise patienten til pædiater (se pkt.
English: In adults and adolescents, the incidence of epistaxis was higher in longer-term use (more than 6 weeks) than in short-term use (up to 6 weeks).
Danish: Hos voksne og unge var forekomsten af epistaxis hyppigere ved længere tids anvendelse (over 6 uger) end ved kort tids anvendelse (max. 6 uger).
English: *Epistaxis was generally mild to moderate in intensity.
Danish: Intranasale ulcerationer *Epistaxis var generelt mild til moderat i intensitet.
English: Alisade is indicated for the treatment of: • the symptoms of allergic rhinitis
Danish: Alisade er indiceret til behandling af: • symptomer på allergisk rhinitis
English: Urinary excretion accounted for approximately 1 % and 2 % of the orally and intravenously administered dose, respectively.
Danish: Udskillelse via urinen omfattede ca. 1 % og 2 % af henholdsvis den perorale og intravenøse dosis.
English: Nasal spray, suspension 1 bottle - 30 sprays 1 bottle - 60 sprays 1 bottle - 120 sprays
Danish: Næsespray 1 flaske - 30 pust 1 flaske - 60 pust 1 flaske - 120 pust
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at lægemiddelovervågningssystemet, som er beskrevet i markedsføringstilladelsen (Modul 1.8.1), er på plads og fungerer, før produktet når markedet, og så længe produktet er markedsført.
English: Very common side effects (These can affect more than 1 person in 10) • Nosebleeds (generally minor), particularly if you use Alisade for more than 6 weeks continuously.
Danish: Meget almindelige bivirkninger (det sker hos flere end 1 ud af 10 patienter): • Næseblod (som regel let), især hvis du bruger Alisade i over 6 uger.
English: Data from large clinical trials were used to determine the frequency of adverse reactions.
Danish: Der er anvendt data fra store kliniske forsøg til bestemmelse af hyppigheden af bivirkninger.
English: Follow the guide carefully to get full benefit from using Alisade
Danish: Følg nøje vejledningen for at få fuldt udbytte af Alisade.
English: • Always keep the cap on the nasal spray when you are not using it.
Danish: • Sprayen skal altid have hætten på, når du ikke bruger den.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version GM2006/00247/05 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen forpligter sig til at udføre de studier og lægemiddelovervågningsaktiviteter, der er beskrevet i lægemiddelovervågningsplanen, som aftalt i version GM2006/00247/05 af risikostyringsplanen (RMP) beskrevet i modul 1.8.2. i ansøgningen om markedsføringstilladelsen, og i efterfølgende krav fra CHMP til opdateringer af RMP.
English: Do not use Alisade if you are pregnant, or planning to become pregnant, unless your doctor or pharmacist tells you to.
Danish: Du må ikke bruge Alisade, hvis du er gravid eller har planer om at blive det, medmindre lægen eller apoteket siger det.
English: Findings in general toxicology studies were similar to those observed with other glucocorticoids and are associated with exaggerated pharmacological activity.
Danish: Fund i generelle toksikologiske forsøg svarede til dem, der sås med andre glukokortikoider, og tilskrives overdrevet farmakologisk aktivitet.
English: 6 Take the nozzle out and breathe out through your mouth.
Danish: Fjern næsesprayen fra næsen, og pust ud gennem munden.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/474/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/474/01
English: The nasal spray comes in a brown 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 ligger i en brun glasflaske i en kappe af plastic - se billede a. Den indeholder enten 30, 60 eller 120 pust, alt efter hvilken pakningsstørrelse, der er blevet ordineret.
English: Important information about some of the ingredients of Alisade Alisade contains benzalkonium chloride.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Alisade Alisade indeholder benzalkoniumchlorid.
English: Pregnancy and breast-feeding Ask your doctor for advice before taking any medicine.
Danish: Graviditet og amning Spørg din læge eller apoteket til råds, før du bruger nogen form for medicin.
English: • before you use it for the first time
Danish: • Før næsesprayen anvendes første gang
English: In paediatric clinical studies of up to 12 weeks duration the incidence of epistaxis was similar between patients receiving fluticasone furoate and patients receiving placebo.
Danish: pædiatriske kliniske forsøg af op til 12 ugers varighed var forekomsten af epistaxis den samme hos patienter, der fik fluticasonfuroat, og hos patienter, der fik placebo.
English: Alisade contains benzalkonium chloride.
Danish: Alisade indeholder benzalkoniumchlorid.
English: Some people will not feel the full effects until several days after first using Alisade.
Danish: Nogle mennesker får først maksimal virkning efter flere dages brug.
English: • if you have left the cap off
Danish: • Hvis du har glemt at sætte hætten på
English: A study of a single 400 microgram dose of orally inhaled fluticasone furoate in patients with moderate hepatic impairment 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 forsøg med en enkelt dosis på 400 mikrogram inhaleret fluticasonfuroat hos patienter med moderat nedsat leverfunktion resulterede i øget Cmax (42 %) og AUC(0-∞) (172 %) og et beskedent (gennemsnitlig 23 %) fald i serumkortisol hos patienter sammenlignet med raske frivillige.
English: Therefore close monitoring is warranted in patients with a change in vision or with a history if increased pressure, glaucoma and/or cataracts.
Danish: Derfor tilrådes tæt monitorering hos patienter, hvor der sker synsændringer, eller hvor der tidligere er set øget intraokulært tryk, glaukom og/eller katarakt.
English: Follow these steps:
Danish: Følg vejledningen herunder:
English: If the level is very low there may not be enough left to work the nasal spray.
Danish: Hvis væsken står lavt, er der muligvis ikke nok tilbage til at få et pust ud.
English: Nasal and inhaled corticosteriods may result in the development of glaucoma and/or cataracts.
Danish: Intranasale og inhalerede kortikosteroider kan forårsage udvikling af glaukom og/eller katarakt.
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 Sfluorometylkarbotioatfunktionen for at danne 17β-karboxylsyremetabolitten.
English: This small increase in exposure did not result in a statistically significant difference in 24 hour serum cortisol levels between the two groups (see section
Danish: Denne lille forøgelse i påvirkningen var ikke statistisk signifikant i 24 timers serumkortisolkoncentrationer (se pkt.
English: Alisade nasal spray should be used within 2 months after first opening.
Danish: Alisade næsespray skal bruges senest to måneder efter flasken blev åbnet første gang.
English: Children under 6 years of age: The experience in children under the age of 6 years is limited (see section 5.1 and 5.2).
Danish: Børn under 6 år: Erfaring med behandling af børn under 6 år er begrænset (se pkt.
English: • ritonavir, used to treat HIV
Danish: • ritonavir, hiv-medicin
English: Metabolism: 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: Metabolisme: 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: 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 vejrtrækningsproblemer - Pludselig fornemmelse af svaghed eller svimmelhed (der kan føre til kollaps eller bevidstløshed) - Hævelse i ansigtet - Udslæt eller rødme
English: Do not use Alisade: If you are allergic (hypersensitive) to fluticasone furoate or any of the other ingredients of Alisade.
Danish: Brug ikke Alisade hvis du er overfølsom (allergisk) over for det aktive stof eller et af de øvrige indholdsstoffer.
English: If you forget to use AlisadeIf you miss a dose, take it when you remember.
Danish: Hvis du glemmer en dosis, skal du tage den, når du kommer i tanke om det.
English: In a bioavailability study, intranasal doses of up to 2640 micrograms per day were administered over three days with no adverse systemic effects 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: Your doctor may adjust your dose of Alisade.
Danish: Din læge vil muligvis ændre din dosis.
English: Therefore moderate hepatic impairment is not predicted to result in a clinically relevant effect for the normal adult dose.
Danish: Derfor forventes en moderat nedsat leverfunktion ikke at resultere i en klinisk relevant påvirkning med den anbefalede dosis for voksne.
English: SPECIAL STORAGE CONDITIONS Do not refrigerate or freeze
Danish: Må ikke opbevares i køleskab eller nedfryses
English: No studies on the effects on the ability to drive and use machines have been performed as fluticasone furoate is not expected to affect this ability.
Danish: Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene maskiner, idet der ikke forventes påvirkning fra fluticasonfuroat.
English: Adults, adolescents (12 years and over) and children (6 - 11 years)
Danish: Voksne og unge (fra 12 år) og børn (6-11 år)
English: • may cause eye conditions such as glaucoma (increase in pressure in the eye) or cataracts (clouding of the lens of the eye).
Danish: • kan være årsag til øget tryk i øjet (glaukom) eller sløret syn (katarakt).
English: Glucose anhydrous Dispersible cellulose Polysorbate 80
Danish: Vandfrit glukose Dispergibel cellulose Polysorbat 80
English: Therefore, no clinical studies have been conducted to investigate interactions of fluticasone furoate on other drugs.
Danish: Der er derfor ikke gennemført kliniske forsøg med det formål at undersøge interaktioner mellem fluticasonfuroat og andre lægemidler.
English: Hypersensitivity to the active substance or to any of the excipients of Alisade.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne.
English: Treatment with higher than recommended doses of nasal corticosteroids may result in clinically significant adrenal suppression.
Danish: Behandling med højere doser intranasale kortikosteroider end de anbefalede kan resultere i klinisk signifikant binyrebarksuppression.
English: • ketoconazole, used to treat fungal infections
Danish: • ketoconazol, medicin mod svampeinfektioner
English: • Try to reset it by following the instructions under ‘Preparing the nasal spray for use'.
Danish: Prøv at få den til at virke ved at følge vejledningen under ”Klargøring af næsesprayen”.
English: Elimination: 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: Elimination: Eliminationen skete primært via fæces efter peroral og intravenøs administration, hvilket tyder på udskillelse af fluticasonfuroat og dets metabolitter med galden.
English: Growth retardation has been reported in children receiving some nasal corticosteroids at licensed doses.
Danish: Væksthæmning er indberettet for børn, der har fået visse intranasale kortikosteroider i anbefalede doser.
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 CYP3A4-hæmmer ketoconazol, var koncentrationen af fluticasonpropionat målbar hos flere i gruppen, der fik ketoconazol (hos 6 ud af 20), i sammenligning med placebogruppen (hos 1 ud af 20).
English: Absorption: Fluticasone furoate undergoes incomplete absorption and extensive first-pass metabolism in the liver and gut resulting in negligible systemic exposure.
Danish: Absorption: Fluticasonfuroat absorberes ufuldstændigt, og omfattende first-pass metabolisme i lever og tarm resulterer i negligeabel systemisk påvirkning.
English: The cap keeps the dust out, seals in the pressure and stops the nozzle from blocking up.
Danish: Den holder støv ude, holder på trykket og forhindrer næsestudsen i at blive tilstoppet.
English: Always keep the cap on. Do not use Alisade after the expiry date which is stated on the label and carton.
Danish: Brug ikke Alisade efter den udløbsdato, der står på pakningen.
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 dt med til at sikre, at du får hele din dosis.
English: It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored.
Danish: Det anbefales, at højden måles jævnligt på børn i langtidsbehandling med intranasale kortikosteroider.
English: • If you think the nozzle may be blocked, do not use a pin or anything sharp to clear it.
Danish: Hvis næsestudsen kan være tilstoppet, må du ikke bruge en nål eller noget skarpt for at få hul igennem.
English: Hepatic Impaired Patients: No dose adjustment is required in mild to moderate hepatic impairment.
Danish: Patienter med nedsat leverfunktion: Der er ikke behov for dosisændringer til patienter med mild til moderat hepatisk insufficiens.
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 forsøg.
English: Based on data with another glucocorticoid (fluticasone propionate), that is metabolised by CYP3A4, co-administration 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: From this study the average predicted exposure of 110 micrograms of intranasal fluticasone furoate in patients with moderate hepatic impairment would not be expected to result in suppression of cortisol.
Danish: På baggrund af dette forsøg forventes en gennemsnitlig optagelse fra 110 mikrogram intranasalt fluticasonfuroat til patienter med moderat nedsat leverfunktion ikke at resultere i nedsat binyrebarkfunktion.
English: There are no data in patients with severe hepatic impairment.
Danish: Der findes ingen data fra patienter med svært nedsat leverfunktion.
English: Caution is recommended when co-administering fluticasone furoate with potent CYP3A4 inhibitors as an increase in systemic exposure cannot be ruled out.
Danish: Forsigtighed tilrådes ved samtidig behandling med potente CYP3A4-hæmmere, da øget systemisk påvirkning ikke kan udelukkes.
English: It is unknown whether nasal administered fluticasone furoate is excreted in human breast milk.
Danish: Det vides ikke, om intranasal fluticasonfuroat udskilles i modermælken.
English: Alisade is available in pack sizes 30, 60 and 120 sprays.
Danish: Alisade fås i pakninger med 30, 60 og 120 pust.
English: Greenford, Middlesex, UB6 0NN United Kingdom
Danish: Greenford, Middlesex, UB6 0NN Storbritannien
English: Alisade 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: Alisade næsespray anvendes til behandling af allergi (sæson- og helårsbetinget), herunder tilstoppet eller løbende næse, nysen og rindende, kløende og røde øjne hos voksne og børn fra 6 år.
English: 3 Never use a pin or anything sharp on the nozzle.
Danish: Brug aldrig en nål eller noget skarpt til næsestudsen.
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: Alisade belongs to a group of medicines called glucocorticoids.
Danish: Alisade tilhører den gruppe lægemidler, som hedder binyrebarkhormoner.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Glaxo Group Ltd
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Glaxo Group Ltd
English: It may then be possible for the dose to be reduced to 1 spray in each nostril once every day.
Danish: Dosis kan derefter måske nedsættes til 1 pust i hvert næsebor 1 gang daglig.
English: The PSUR cycle of Alisade will correspond to the one attributed to the cross-referred product, Avamys, until otherwise specified.
Danish: PSURs PSUR-cyklus for Alisade følger den for Avamys, indtil andet besluttes.
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 24hour serum cortisol profiles, compared with placebo.
Danish: Et 6 ugers forsøg, 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: The other ingredients are glucose anhydrous, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, purified water.
Danish: Øvrige indholdsstoffer: vandfrit glucose, dispergibel cellulose, polysorbat 80, benzalkoniumchlorid, dinatriumedetat, renset vand.
English: • Use once a day
Danish: • 1 gang daglig
English: Results from a placebo-controlled knemometry study of fluticasone furoate nasal spray 110 micrograms once daily revealed no clinically relevant effects on short-term lower leg growth rate in children (6 to 11 years).
Danish: Resultaterne fra et placebokontrolleret knemometriforsøg med fluticasonfuroat næsespray 110 mikrogram 1 gang daglig viste ingen klinisk relevant indvirkning over kortere tid på væksthastigheden på underbenet hos børn (6-11 år).
English: ATC code: R01AD12
Danish: Farmakoterapeutisk klassifikation: Kortikosteroider, ATC-kode: R01AD12
English: It will damage the nasal spray.
Danish: Det ødelægger næsesprayen.
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: These effects vary between patients and different corticosteroids (see section 5.2).
Danish: Det kan variere fra patient til patient og fra kortikosteroid til kortikosteroid (se pkt.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 30 pust
English: Alisade works to decrease inflammation caused by allergy (rhinitis).
Danish: Alisade har til formål at nedsætte inflammation (betændelsesagtig tilstand) i næsen og irritation i øjnene forårsaget af allergi (rhinitis).
English: Fluticasone furoate is rapidly cleared by extensive first pass metabolism mediated by the cytochrome P450 3A4.
Danish: Der sker en betragtelig first pass-metabolisme af fluticasonfuroat ved hjælp af cytokrom-P450 3A4.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING THE IMMEDIATE PACKAGING>
Danish: MÆRKNING, DER SKAL ANFØRES <PÅ DEN YDRE EMBALLAGE> <OG> <PÅ DEN INDRE EMBALLAGE>
English: How long Alisade takes to work
Danish: Hvor meget Alisade skal der bruges?
English: The window in the plastic casing lets you see how much Alisade is left in the bottle.
Danish: I vinduet på siden af næsesprayen kan du se, hvor meget medicin der er tilbage.
English: Common side effects (These can affect less than 1 person in 10 and more than 1 person in 100)
Danish: Almindelige bivirkninger (det sker hos mellem 1 og 10 ud af 100 patienter):
English: Elderly Patients: No dose adjustment is required in this population (see section 5.2).
Danish: Ældre patienter: Der er ikke behov for dosisændringer til denne patientgruppe (se pkt.
English: United Kingdom
Danish: UK
English: Seasonal Allergic Rhinitis in adults and adolescents 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 forsøg.
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 forsøg.
English: MARKETING AUTHORISATION HOLDER Glaxo Group Ltd
Danish: Indehaver af markedsføringstilladelsen Glaxo Group Ltd
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each spray actuation delivers 27.5 micrograms of fluticasone furoate.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Et pust afgiver 27,5 mikrogram fluticasonfuroat.
English: Do not use Alisade if you are breast feeding unless your doctor or pharmacist tells you to.
Danish: Hvis du ammer, må du ikke bruge Alisade, medmindre lægen eller apoteket siger det.
English: Adults and Adolescents (12 years and over)
Danish: Voksne og unge (fra 12 år)
English: No genotoxic effects of fluticasone furoate have been observed in conventional genotoxicity tests.
Danish: Ved observation i konventionelle genotoksicitetsforsøg sås ingen genotoksisk effekt af fluticasonfuroat.
English: EXPIRY DATE EXP {MM/YYYY] In-use shelf life: 2 months
Danish: EXP Efter anbrud: 2 måneder
English: Administration of fluticasone furoate to women who are breastfeeding 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.