FrancophonIA/ELRC3.0 huggingface dataset:
English: If your symptoms are well controlled using Viani Evohaler twice daily, your doctor may decide to reduce your dose to once daily.
Danish: Hvis dine symptomer er velkontrollerede på Viani Evohaler to gange daglig, kan din læge forsøge at nedsætte dosis til en gang daglig.
English: Note: This Annex III (Summary of Product Characteristics, Labelling and Package Leaflet) is the one that was Annexed to the Commission Decision on this Article 6(13) referral for Viani Evohaler and associated names.
Danish: Bemærk: Dette bilag III (Produktresumé, Etikettering og Indlægsseddel) var bilag til Europa-Kommissionens beslutning angående denne artikel 6(13) arbitreringssag vedrørende Viani Evohaler og tilknyttede navne.
English: Take care not to drop the inhaler as this may cause the counter to count down.
Danish: Pas på ikke at tabe sprayen, det kan få dosistælleren til at tælle ned.
English: The disposition of fluticasone propionate is characterised by high plasma clearance (1150ml/min), a large volume of distribution at steady-state (approximately 300l) and a terminal half-life of approximately 8 hours.
Danish: Udskillelsen af fluticasonpropionat er karakteriseret ved høj clearance (1150 ml/minut), stort fordelingsvolumen i steady-state (ca. 300 l) og en terminal halveringstid på ca. 8 timer.
English: Children and adolescents <16years taking high doses of fluticasone (typically ≥ 1000mcg/day) may be at particular risk.
Danish: Børn og unge under 16 år, der får høje doser fluticasonpropionat (typisk > 1000 mikg/dag), er specielt i risikogruppen.
English: If your asthma gets worse or is not well controlled (you will feel wheezy and need more of your fast acting ‘rescue' medicine), do not increase the number of puffs of Viani you take.
Danish: Hvis din astma forværres eller er ikke er velkontrolleret (hvis din vejrtrækning er hvæsende, og du har brug for mere anfaldsmedicin), skal du ikke øge antallet af inhalationer af Viani.
English: Adults and adolescents 12 years and over
Danish: Voksne og unge fra 12 år
English: Instructions for proper use Your doctor, nurse or pharmacist should instruct you in the proper use of your inhaler.
Danish: Brugsanvisning Få lægen, sygeplejersken eller apoteket til at vise dig, hvordan du skal bruge din spray.
English: In addition there are only limited data available on the pharmacokinetics of salmeterol because of the technical difficulty of assaying the drug in plasma due to the low plasma concentrations at therapeutic doses (approximately 200 picogram/ml or less) achieved after inhaled dosing.
Danish: Derudover er der kun begrænsede oplysninger om salmeterols farmakokinetik, da det er teknisk vanskeligt at måle stoffet i plasma på grund af de lave plasmakoncentrationer (ca. 200 pikogram/ml eller mindre) ved inhalation i terapeutiske doser.
English: There are no data available for use of Viani inhaler in children aged under 4 years.
Danish: Der er ikke lavet undersøgelser med Viani inhalationsspray til børn under 4 år.
English: In several EU Member States Viani Evohaler and associated names (see Annex I) are approved through the Mutual Recognition Procedure (MRP).
Danish: Viani Evohaler og tilknyttede navne (se bilag I) er godkendt i en række EU-medlemsstater gennem proceduren for gensidig anerkendelse.
English: There is no need to adjust the dose in elderly patients or in those with renal impairment.
Danish: Dosisjustering er ikke nødvendig hos ældre eller hos patienter med nedsat nyrefunktion.
English: 10 X 120 puffs (hospital or pharmacy use only)
Danish: 10 x 120 pust (kun til hospitals- og apoteksbrug)
English: Do not stop taking Viani suddenly as this could make your asthma worse and could cause problems with the body's hormones.
Danish: Du må ikke stoppe behandlingen med Viani pludseligt, da dette kan forværre dine symptomer og give problemer med kroppens hormoner.
English: Viani Evohaler is for inhalation use only.
Danish: Viani Evohaler må kun anvendes til inhalation.
English: Well-Controlled asthma was achieved more rapidly with Viani than with ICS alone.
Danish: Velkontrolleret astma blev opnået hurtigere med Viani end med inhalationssteroid alene.
English: United Kingdom Glaxo Wellcome UK Limited Stockley Park West, Uxbridge Middlesex UB11 1BT
Danish: Glaxo Wellcome UK Limited, trading as Allen & Hanburys Stockley Park West, Uxbridge, Middlesex UB11 1BT, Det Forenede Kongerige
English: Important, do not rush steps 4 to 7: 4.
Danish: Det er vigtigt, at du er særlig omhyggelig med punkt 4-7:
English: The suspension is contained in an internally lacquered, 8ml aluminium alloy pressurised container sealed with a metering valve.
Danish: Suspensionen er i en indvendigt lakeret, 8 ml trykbeholder i aluminium, forseglet med doseringsventil.
English: Salmeterol is one of a group of medicines called long-acting bronchodilators (effect lasting for at least 12 hours).
Danish: Salmeterol tilhører gruppen af lægemidler med langtidsvirkende bronkieudvidende effekt (virkningen holder sig i mindst 12 timer).
English: If they see "mist" coming from the top of their inhaler or the sides of their mouth they should start again from stage 2.
Danish: Hvis de ser ”røg” komme op af sprayen eller ud ved mundvigene, skal de gøre det om igen fra pkt.
English: Sudden and progressive deterioration in control of asthma is potentially life-threatening and the patient should undergo urgent medical assessment.
Danish: Pludselig og tiltagende forværring af astmasymptomer er potentielt livstruende og patienten skal snarest tilses af en læge.
English: The pressurised can contains a white to off white suspension for inhalation.
Danish: Spraybeholderen indeholder en hvid til hvidlig suspension til inhalation.
English: 6.2 Incompatibilities
Danish: 6.2 Uforligeligheder Ikke relevant
English: Monitoring of adrenal reserve may be necessary.
Danish: Det kan være nødvendigt at monitorere binyrebarkfunktionen.
English: The container should not be punctured, broken or burnt even when apparently empty.
Danish: Beholderen må ikke punkteres eller brændes, heller ikke når den er tømt.
English: Place the mouthpiece in your mouth between your teeth and close your lips around it. Do not bite it.
Danish: Sæt mundstykket mellem tænderne og lad læberne slutte tæt omkring det uden at bide i det.
English: Two puffs twice a day This medicine if not recommended for use in children below 4 years of age.
Danish: Dette lægemiddel anbefales ikke til børn under 4 år.
English: Potentially serious hypokalaemia may result from systemic beta-2-agonist therapy, but following inhalation at therapeutic doses plasma levels of salmeterol are very low.
Danish: Systemisk behandling med ß2-agonister kan resultere i potentielt alvorlig hypokaliæmi, men efter inhalation i terapeutiske doser er der meget lave plasmakoncentrationer af salmeterol.
English: Do not remove the canister from the plastic casing.
Danish: - Fjern aldrig metalbeholderen fra plastichylstret.
English: This combination of salmeterol and fluticasone propionate when used regularly prevents asthma attacks occurring.
Danish: Kombinationen af salmeterol og fluticasonpropionat forebygger astmaanfald ved regelmæssig brug.
English: 3 X 120 puffs
Danish: 3 x 120 doser
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE Trykbeholder.
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C
Danish: Må ikke opbevares ved over 25°C.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Fortegnelse over hjælpestoffer Norfluran
English: PHARMACEUTICAL FORM AND CONTENTS Pressurised inhalation, suspension 1 X 120 puffs
Danish: Inhalationsspray, suspension 1 x 120 pust
English: The medicine is contained in a pressurised can in a plastic casing with a mouthpiece.
Danish: Medicinen er i en trykbeholder i plastichylster med mundstykke.
English: The maximum licensed dose of fluticasone propionate delivered by Viani inhaler in children is 100mcg twice daily.
Danish: Den maksimale godkendte dosis fluticasonpropionat i Viani spray til børn er 100 mikrogram to gange dagligt.
English: Zone Industrielle No.2, 23 Rue Lavoisier, la madeleine, 27000 Evreux, France.
Danish: Glaxo Wellcome Production Zone Industrielle No 2, 23 rue Lavoisier, La Madeleine 27000 Evreux, Frankrig
English: Symptomatic candidiasis can be treated with topical antifungal therapy whilst still continuing with the Viani Evohaler.
Danish: Symptomatisk candidiasis kan behandles med topikale midler mod svamp samtidig med anvendelse af Viani.
English: Note: Viani 25/50 microgram strength is not appropriate in adults and children with severe asthma.
Danish: Viani 50/100 mikrogram er uegnet til voksne og børn med alvorlig astma.
English: Patients should consider getting a replacement when the counter shows the number 020.
Danish: Patienterne bør anskaffe en ny spray, når dosistælleren viser 20.
English: One pressurised container delivers 120 actuations.
Danish: En inhalationsspray indeholder 120 doser.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS EVOHALER LABEL
Danish: MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: Fluticasone propionate given by inhalation at recommended doses has a glucocorticoid antiinflammatory action within the lungs, resulting in reduced symptoms and exacerbations of asthma, with less adverse effects than when corticosteroids are administered systemically.
Danish: Fluticasonpropionat givet som inhalation i de anbefalede doser giver en glukokortikoid antiinflammatorisk effekt i lungerne, som formindsker symptomer på og forværring af astmaen uden de bivirkninger, der ses ved systemisk steroidbehandling.
English: A short term trial of Viani may be considered as initial maintenance therapy in adults or adolescents with moderate persistent asthma (defined as patients with daily symptoms, daily rescue use and moderate to severe airflow limitation) for whom rapid control of asthma is essential.
Danish: Det kan overvejes at forsøge kortvarigt med Viani som første vedligeholdelsesbehandling hos voksne og unge med moderat astma (defineret som patienter med daglige symptomer, daglig brug for behovsmedicin og moderat til alvorlig begrænset peakflow), hvor der er brug for hurtig indsættende astmakontrol.
English: Patients should never try to alter the numbers on the counter or detach the counter from the metal canister.
Danish: Patienterne bør aldrig prøve at ændre på dosistælleren eller på anden måde at øve vold på den.
English: A spacer device may be used to improve treatment with Viani particularly with young children, if you or your child has difficultly co-ordinating breathing in through your mouth and pressing the can to release a puff at the same time.
Danish: Til små børn kan Viani inhalationsspray bruges i en såkaldt spacer, det kan især være gavnligt, hvis du eller dit barn har svært ved at koordinere inhalationen med samtidig at skulle afgive et pust fra sprayen.
English: To prevent your inhaler blocking up, it is important to clean it at least once a week.
Danish: Rengøring af sprayen Sørg for rengøring af din spray mindst 1 gang om ugen for at undgå tilstopning.
English: It is very important that you take your Viani every day as directed, until you are advised to stop by your doctor.
Danish: Det er meget vigtigt, at du bruger Viani hver dag som anvist, indtil din læge fortæller dig andet.
English: Viani Evohaler and associated names (see Annex I of Opinion) contain salmeterol and fluticasone propionate, a fixed dose combination of the long acting β-agonist (LABA) salmeterol and the inhaled corticosteroid (ICS) fluticasone propionate (FP) indicated in the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate:patients not adequately controlled with inhaled corticosteroids and ‘as needed' inhaled short acting beta-2-agonist or - patients already adequately controlled on both inhaled corticosteroid and longacting beta-2-agonist.
Danish: Viani Evohaler og tilknyttede navne (se bilag I til udtalelsen) indeholder salmeterol og fluticasonpropionat, som er en fastdosiskombination af den langtidsvirkende beta-agonist salmeterol og det inhalerede corticosteroid fluticasonpropionat, der er indiceret til standardbehandling af astma, når det er hensigtsmæssigt at anvende et kombinationsprodukt (langtidsvirkende beta-2-agonist og inhaleret corticosteroid): - hos patienter, som ikke kan kontrolleres tilstrækkeligt med inhalerede corticosteroider og inhaleret korttidsvirkende beta-2-agonist givet efter behov, eller - hos patienter, der allerede kontrolleres tilstrækkeligt med både inhaleret corticosteroid og langtidsvirkende beta-2agonist.
English: In patients with asthma a lesser degree of systemic exposure to inhaled fluticasone propionate has been observed.
Danish: Astmapatienter er i mindre grad udsat for systemisk påvirkning efter inhalation af fluticasonpropionat.
English: The main part of the dose is excreted as faeces as metabolites and unchanged drug.
Danish: Hovedparten udskilles i fæces som metabolitter eller uomdannet.
English: Do not put the metal container in water.
Danish: Metalbeholderen må ikke komme i vand.
English: The recommendation included in section 4.2 allows a short term trial of Viani Evohaler in adults and adolescents with moderate persistent asthma for whom rapid control of asthma is essential.
Danish: Den i afsnit 4.2 indføjede anbefaling giver mulighed for kortvarig forsøgsvis brug af Viani Evohaler hos voksne patienter med moderat persisterende astma og tvingende behov for hurtig astmakontrol.
English: Patients should breathe out as far as is comfortable and then place the mouthpiece in your mouth between their teeth and close their lips around it, Patients should be instructed not to bite the mouth piece.
Danish: Patienten skal puste helt ud og derefter placere mundstykket mellem tænderne og lad læberne slutte tæt omkring det uden at bide i det.
English: Pressurised inhalation, suspension.
Danish: Inhalationsspray, suspension.
English: You should be standing or sitting whilst using the inhaler.
Danish: Du skal helst sidde eller stå op, når du bruger din spray.
English: Your doctor will supervise your treatment more closely if you have medical conditions such as heart disease including an irregular or fast heart beat, overactive thyroid gland, high blood pressure, diabetes mellitus (Viani may increase your blood sugar), low potassium in your blood or if you are being, or have been treated for have tuberculosis (TB).
Danish: Du bør ikke anvende Viani - hvis du lider af hjertesygdomme, herunder uregelmæssig eller hurtig hjertebanken, eller forøget hormonproduktion fra skjoldbruskkirtlen, forhøjet blodtryk, sukkersyge (Viani kan forhøje dit blodsukker), lavt indhold af kalium i blodet, eller hvis du er eller har været i behandling for tuberkulose (tb).
English: The canister has a counter attached to it, which shows how many actuations of medicine are left.
Danish: Beholderen er forsynet med en dosistæller, som viser, hvor mange doser, der er tilbage.
English: Prescribers should be aware that, in patients with asthma, fluticasone propionate is as effective as other inhaled steroids at approximately half the microgram daily dose.
Danish: Lægen skal være opmærksom på, at hos astmapatienter er fluticasonpropionat dobbelt så effektivt som andre steroider til inhalation.
English: Viani Evohaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Danish: I så fald skal Viani straks seponeres, patienten undersøges, og om nødvendigt gives anden behandling.
English: Increasing use of short-acting bronchodilators to relieve asthma symptoms indicates deterioration of asthma control and patients should be reviewed by a physician.
Danish: Øget brug af korttidsvirkende bronkodilatatorer betyder forværring, og patientens tilstand bør revurderes af en læge.
English: GlaxoSmithKline SA Parque Tecnologico de Madrid, Calle Severo Ochoa 2, 28760 Tres Cantos, Madrid Spain
Danish: GlaxoSmithKline SA Parque Tecnologico de Madrid, Calle Severo Ochoa 2, 28760, Tres Cantos, Madrid, Spanien
English: The use of a spacer device with the inhaler in order to derive greater therapeutic benefit is recommended for patients (in particular young children) who have difficulty co-ordinating inhalation with actuation (see section 4.4 Special Warnings and Precautions for use)
Danish: Brugen af spacer sammen med inhalationssprayen for større terapeutisk effekt anbefales til patienter (især små børn), som har svært ved samtidig at inhalere og aktivere sprayen (se pkt.
English: The doctor will prescribe the lowest strength of Viani Evohaler that will best control your symptoms.
Danish: Din læge vil bestræbe sig på at ordinere den laveste dosis Viani Evohaler, som kan holde dine symptomer under kontrol.
English: Hold the inhaler upright with your thumb on the base, below the mouthpiece.
Danish: Hold sprayen lodret med tommelfingeren på basis under mundstykket.
English: Rinse your mouth with water and spit it out as this may help prevent the occurrence of thrush and hoarseness.
Danish: Skyl munden med vand og spyt ud - eller børst tænder - for at modvirke svamp og hæshed.
English: Viani Evohaler United Kingdom Viani Evohaler
Danish: Viani Evohaler Det Forenede Kongerige Viani Evohaler
English: - Wipe the inside and outside of the mouthpiece and the plastic casing with a dry cloth or tissue.
Danish: - Tør mundstykket indvendigt og udvendigt og tør plastichylstret med en tør klud.
English: Inhalation use
Danish: Brug af inhalationsspray
English: If patients are going to take a second puff they should keep the inhaler upright and wait about half a minute before repeating steps 2 to 6.
Danish: Hvis patienten får ordineret endnu et pust, skal sprayen holdes lodret, og der skal gå ½ minut, før pkt.
English: The non-CFC propellant, Norflurane, has been shown to have no toxic effect at very high vapour concentrations, far in excess of those likely to be experienced by patients, in a wide range of animal species exposed daily for periods of two years.
Danish: Det er blevet påvist ved daglig anvendelse igennem to år på en lang række forskellige dyrearter, at det tilsatte CFC-frie drivmiddel, norfluran, ikke har nogen toksisk effekt selv ved langt højere forstøvningskoncentrationer, end patienter sandsynligvis nogensinde vil få det.
English: The number will show through a window in the back of the plastic actuator.
Danish: Antal doser ses i et vindue i plastichylstret (dosistæller).
English: Do not store Viani Evohaler in a cold place, as your medicine may not work as well.
Danish: Viani må ikke opbevares koldt, da det kan forringe virkningen af medicinen.
English: Each puff provides 25 micrograms of salmeterol (as xinafoate) together with either 50, 125 or 250 micrograms of fluticasone propionate.
Danish: Hvert pust indeholder 25 mikrogram salmeterol som salmeterolxinafoat sammen med 50, 125 eller 250 mikrogram fluticasonpropionat.
English: Shake the inhaler before use.
Danish: Læs indlægssedlen inden brug.
English: Instructions for Use:
Danish: Afprøvningsresultater:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each single actuation of Viani provides:
Danish: Hver dosis Viani indeholder:
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Udfyldes nationalt] [Se bilag I - Udfyldes nationalt]
English: Both non-selective and selective beta-blockers should be avoided in patients with asthma, unless there are compelling reasons for their use.
Danish: Både selektive og ikke-selektive ß-blokkere skal så vidt muligt undgås.
English: Pooled results across the 3 treatment levels *Well controlled asthma; occasional symptoms or SABA use or less than 80% predicted lung function plus no night-time awakenings, no exacerbations and no side effects enforcing a change in therapy **Total control of asthma; no symptoms, no SABA use, greater than or equal to 80% predicted lung function, no night-time awakenings, no exacerbations and no side effects enforcing a change in therapy.
Danish: **) Total kontrol blev defineret som: ingen symptomer, ingen brug af korttidsvirkende ß2-agonister (behovsmedicin), ≥ 80 % af forventet lungefunktion, ingen natlig opvågnen, ingen eksacerbationer og ingen bivirkninger, der førte til ændring i behandlingen.
English: The time on treatment for 50% of subjects to achieve a first individual Well-Controlled week was 16 days for Viani compared to 37 days for the ICS group.
Danish: Der gik 16 dage med behandling med Viani, før 50% af patienterne opnåede velkontrolleret astma i sammenligning med 37 dage for den gruppe, der fik inhalationssteroid alene.
English: - Remove the mouthpiece cover.
Danish: - Fjern beskyttelseshætten fra mundstykket.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: PHARMACEUTICAL FORM Pressurised inhalation, suspension.
Danish: LÆGEMIDDELFORM Inhalationsspray, suspension.
English: The initial starting dose is 2 inhalations of 25 mcg salmeterol and 50 mcg FP twice daily.
Danish: Startdosis er 2 inhalationer af 25 mcg salmeterol/100 mcg fluticasonpropionat to gange dagligt.
English: Patients should hold the inhaler upright between fingers and thumb with their thumb on the base, below the mouthpiece.
Danish: Sprayen skal holdes lodret med tommelfingeren på basis under mundstykket.
English: The containers are fitted into plastic actuators incorporating an atomising mouthpiece and fitted with dustcaps.
Danish: Beholderen er monteret i plastichylster med mundstykke og beskyttelseshætte.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications Viani is indicated in the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate: patients not adequately controlled with inhaled corticosteroids and ‘as needed' inhaled short acting beta-2-agonist or patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2-agonist.
Danish: KLINISKE OPLYSNINGER 4.1 Terapeutiske indikationer Astma Til behandling af astma, hvor behandling med et kombinationsprodukt (langtidsvirkende ß2-agonist og inhalationssteroid) er hensigtsmæssig: - hos patienter, der ikke er velkontrollerede på inhalationssteroid og korttidsvirkende ß2-agonist ved behov,
English: Medium dose ICS (>500-1000mcg BDP or equivalent/day)
Danish: Moderat dosis inhalationssteroid (>5001000mikg beclometasondipropionat eller tilsvarende/dgl.)
English: Before using for the first time patients should remove the mouthpiece cover by gently squeezing the sides of the cover, shake the inhaler well, and release puffs into the air until the counter reads 120 to make sure that it works.
Danish: Før inhalationssprayen tages i brug første gang, rystes den omhyggeligt, og den trykkes af ud i luften, indtil dosistælleren står på 120.
English: INSTRUCTIONS ON USE
Danish: Anvendes senest
English: - The other ingredient is Norflurane (HFA 134a).
Danish: Det øvrige indholdsstof er norfluran.
English: What Viani contains - The active substance(s) are 25 micrograms salmeterol (as xinafoate) and 50, 125 or 250
Danish: YDERLIGERE OPLYSNINGER Viani indeholder - De aktive stoffer er 25 mikrogram salmeterol som salmeterolxinafoat og 50, 125 eller 250 mikrogram fluticasonpropionat.
English: What Viani looks like and contents of the pack Pressurised inhalation, suspension.
Danish: Produktets udseende og pakningstørrelse Inhalationsspray, suspension.
English: As systemic absorption is largely through the lungs, the use of a spacer plus metered dose inhaler may increase drug delivery to the lungs.
Danish: Da brugen af spacer sammen med inhalationssprayen kan øge mængden af det aktive stof i lungerne, kan det eventuelt føre til øget risiko for systemiske bivirkninger, idet den systemiske absorption hovedsageligt sker gennem lungerne.
English: Low dose ICS ( ≤500mcg BDP or equivalent/day)
Danish: Lav dosis inhalationssteroid (≤ 500mikg beclometasondipropionat eller tilsvarende/dgl.)