FrancophonIA/ELRC3.0 huggingface dataset:
English: Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal surgery or trauma should not use a nasal corticosteroid until healing has occurred.
Danish: Da kortikosteroider har ens hæmmende effekt på sårheling bør patienter, som for nyligt har gennemgået nasalkirurgi eller har pådraget sig nasale traumer, ikke anvende nasale kortikosteroider, før opheling har fundet sted.
English: Epistaxis was generally self-limiting and mild in severity (see section 4.8).
Danish: Epistaxis var generelt selvbegrænsende og forekom i let grad (se pkt.
English: Prime by pumping 10 times before initial use, or 2 times if unused for 14 days or more, until a fine mist is produced.
Danish: Tryk på pumpen 10 gange før første anvendelse og 2 gange, hvis den ikke har været anvendt i 14 dage eller mere, indtil der ses en ensartet forstøvning.
English: “not known (cannot be estimated from the available data)”.
Danish: Hyppigheden af bivirkninger rapporteret efter markedsføring anses for ”ikke kendt (kan ikke estimeres ud fra forhåndenværende data)”.
English: Epistaxis was generally self-limiting and mild in severity, and occurred at a higher incidence compared to placebo (5%), but at a comparable or lower incidence when compared to the active control nasal corticosteroids studied (up to 15%) as reported in clinical studies for allergic rhinitis.
Danish: Det forekom med en højere incidens end med placebo (5 %), men med en sammenlignelig eller lavere incidens end rapporteret for de nasale kortikosteroider, der blev undersøgt som aktiv kontrol i kliniske studier af allergisk rhinitis (op til 15 %).
English: What is Nasonex used for?
Danish: Hvad bruges Nasonex til?
English: Nasal Polyps
Danish: Nasale polypper
English: If you are taking other corticosteroid medicines for allergy, either by mouth or injection, your doctor may advise you to stop taking them once you begin using Nasonex.
Danish: Hvis du tager anden medicin mod allergi, som indeholder kortikosteroider, enten gennem munden (f.eks. tabletter) eller ved indsprøjtning, kan det være, at din læge råder dig til at stoppe behandlingen, før du begynder på Nasonex.
English: Local Nasal Effects
Danish: Lokal nasal virkning
English: In cell culture, mometasone furoate demonstrated high potency in inhibition of synthesis and release of IL-1, IL-5, IL-6 and TNFα; it is also a potent inhibitor of leukotriene production.
Danish: I cellekulturer fandtes mometasonfuroat at medføre stor hæmning af syntesen og frigørelsen af IL-1, IL-5, IL-6 og TNFα.
English: The European Medicines Agency has waived the obligation to submit the results of studies with NASONEX Nasal Spray and associated names in all subsets of the paediatric population in seasonal and perennial allergic rhinitis (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Nasonex næsespray i alle undergrupper af den pædiatriske population ved sæsonbetinget rhinitis og helårsrhinitis (se pkt.
English: Nasonex is used to treat the symptoms of hayfever (also called seasonal allergic rhinitis) and perennial rhinitis in adults and children aged 3 and older.
Danish: Nasonex bruges til behandling af symptomer på høfeber (også kaldet sæsonbetinget allergisk rhinitis) og helårssnue hos voksne og børn i alderen 3 år og derover.
English: 140 actuations
Danish: 140 doser
English: This has been demonstrated by decreases (vs placebo) in histamine and eosinophil activity and reductions (vs baseline) in eosinophils, neutrophils, and epithelial cell adhesion proteins.
Danish: Dette er vist (i forhold til placebo) ved en reduktion i histamin- og eosinofilaktiviteten og ved en reduktion (i forhold til basisniveauet) af eosinofile, neutrofile og epitheliale celleadhæsionsproteiner.
English: If localised fungal infection of the nose or pharynx develops, discontinuance of NASONEX Nasal Spray therapy or appropriate treatment may be required.
Danish: Såfremt der udvikles svampeinfektion i næsen eller svælget, kan seponering af Nasonex næsespray eller behørig behandling herfor, blive nødvendig.
English: However, patients who are transferred from long-term administration of systemically active corticosteroids to NASONEX Nasal Spray require careful attention.
Danish: Patienter, som overgår fra langvarig systemisk kortikosteroidbehandling til Nasonex næsespray, skal dog følges nøje.
English: Common side effects (may affect up to 1 in 10 people): headache sneezing nose bleeds [occurred very commonly (may affect more than1 in 10 people) in people with nasal polyps receiving Nasonex two sprays in each nostril twice a day] sore nose or throat ulcers in the nose respiratory tract infection
Danish: • næseblod [forekom meget hyppigt (kan berøre flere end 1 ud af 10 personer) hos personer med næsepolypper, som fik to pust Nasonex i hvert næsebor to gange dagligt]
English: Systemic corticosteroid withdrawal in such patients may result in adrenal insufficiency for a number of months until recovery of HPA axis function.
Danish: Seponering af systemisk kortikosteroidbehandling hos sådanne patienter kan resultere i binyrebarkinsufficiens i flere måneder, indtil hypothalamus-hypofysebinyrebarkfunktionen er genoprettet.
English: In studies of reproductive function, subcutaneous mometasone furoate, at 15 micrograms/kg prolonged gestation and prolonged and difficult labour occurred with a reduction in offspring survival and body weight or body weight gain.
Danish: I reproduktionsstudier forlængede subkutant mometasonfuroat i doser på 15 mikrogram/kg drægtighedstiden og forlængede og besværliggjorde fødslen med nedsat overlevelse, lavere vægt eller langsommere vægtøgning hos afkommet.
English: Start to breathe in gently or slowly through your nose and whilst you are breathing in squirt a spray of fine mist into your nose by pressing down ONCE with your fingers.
Danish: Træk vejret langsomt ind gennem næsen og spray en ensartet forstøvning ind i næsen, samtidig med du trækker vejret ind, ved at trykke 1 gang ned med fingrene.
English: Nasonex is not recommended in case of nasal septum perforation (see section 4.8).
Danish: Nasonex anbefales ikke i tilfælde af perforation af nasalseptum (se pkt.
English: It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored.
Danish: Det anbefales, at højden af børn kontrolleres regelmæssigt under længerevarende behandling med nasale kortikosteroider.
English: Effects noted were umbilical hernia in rats, cleft palate in mice and gallbladder agenesis, umbilical hernia, and flexed front paws in rabbits.
Danish: De observerede virkninger var: Umbilikalhernie hos rotter, ganespalte hos mus samt galdeblære-agenesi, umbilikalhernie og bøjede forpoter hos kaniner.
English: Benzalkonium chloride,
Danish: Benzalkoniumchlorid
English: If you are using the spray for the first time you need to ‘prime' the bottle by pumping the spray 10 times until a fine mist is produced:
Danish: Hvis du anvender sprayen for første gang skal du klargøre flasken ved at pumpe med sprayen 10 gange indtil, der fremkommer en ensartet forstøvning:
English: if you have an infection of the nose or throat.
Danish: • hvis du har en infektion i næsen eller i svælget.
English: Shake gently before use.
Danish: Omrystes let før brug.
English: Once symptoms are controlled, dose reduction to one actuation in each nostril (total dose 100 micrograms) may be effective for maintenance.
Danish: På det tidspunkt, hvor symptomerne er under kontrol, kan en dosisreduktion til et pust i hvert næsebor (totaldosis 100 mikrogram) én gang dagligt være effektivt til vedligeholdelse af behandlingen.
English: NASONEX and associated names strength pharmaceutical form [See Annex I - To be completed nationally]
Danish: Nasonex og relaterede navne styrke lægemiddelform [Se bilag I - Udfyldes nationalt]
English: if you have persistent irritation to the nose or throat.
Danish: • hvis du har vedvarende irritation i næsen eller svælget.
English: Also contains : dispersible cellulose, glycerol, sodium citrate, citric acid monohydrate, polysorbate 80, benzalkonium chloride, purified water.
Danish: Indeholder også: mikrokrystallinsk cellulose og carmellosenatrium (dispergibel cellulose), glycerol, natriumcitrat, citronsyremonohydrat, polysorbat 80, benzalkoniumchlorid, renset vand.
English: MARKETING AUTHORISATION NUMBER
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)
English: As with other nasal corticosteroid preparations, a decision must be made whether to discontinue breast-feeding or to discontinue/abstain from NASONEX Nasal Spray therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Som ved andre nasale kortikosteroidpræparater skal det besluttes, om amning eller behandling med Nasonex næsespray skal ophøre/ikke skal startes, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: When mometasone furoate is sprayed into the nose, it can help to relieve inflammation (swelling and irritation of the nose), sneezing, itching and a blocked up or runny nose.
Danish: Når mometasonfuroat sprayes op i næsen, kan det afhjælpe en betændelsesagtig tilstand i næsen (inflammation (hævelse og irritation i næsen)) samt nysen, kløe og stoppet (tæt næse) eller løbenæse.
English: NASONEX Nasal Spray should not be used in the presence of untreated localised infection involving the nasal mucosa, such as herpes simplex.
Danish: Nasonex næsespray bør ikke anvendes ved samtidig ubehandlet lokalinfektion i næseslimhinden, så som herpes simplex.
English: Seasonal Allergic Rhinitis and Perennial Rhinitis The safety and efficacy of NASONEX Nasal Spray in children under 3 years of age have not been established.
Danish: Sæsonbetinget allergisk rhinitis og helårsrhinitis Sikkerheden og virkningen af Nasonex næsespray hos børn under 3 år er ikke klarlagt.
English: When corticosteroid nasal sprays are used at high doses for long periods of time, side effects may occur due to the drug being absorbed in the body.
Danish: Ved brug af kortikosteroid-næsesprays ved høje doser i lange perioder, kan der forekomme bivirkninger, idet medicinen absorberes i kroppen.
English: While you are using Nasonex, talk to your doctor if your immune system is not functioning well (if you have difficulty in fighting infection) and you come into contact with anyone with measles or chickenpox.
Danish: • hvis dit immunsystem ikke fungerer godt (hvis du har svært ved at bekæmpe infektioner), og du kommer i kontakt med personer, der har mæslinger eller skoldkopper.
English: • [To be completed nationally]
Danish: • [Udfyldes nationalt]
English: Adults (including older patients) and children 12 years of age and older: The usual recommended dose is two actuations (50 micrograms/actuation) in each nostril once daily (total dose 200 micrograms).
Danish: Voksne (herunder ældre patienter) og børn på 12 år og derover: Den sædvanligt anbefalede dosis er to pust (50 mikrogram/pust) i hvert næsebor én gang daglig (totaldosis 200 mikrogram).
English: No toxicological effects unique to mometasone furoate exposure were demonstrated.
Danish: Der kunne ikke påvises toksiske virkninger alene forårsaget af mometasonfuroat.
English: Push the nozzle back onto the bottle and replace the dust cap.
Danish: Sæt tuden tilbage på flasken og sæt støvhætten på igen.
English: Close one nostril and put the nozzle into the other nostril as shown.
Danish: Hold for det ene næsebor og før spidsen af næsesprayen ind i det andet som vist.
English: Allow the dust cap and nozzle to dry in a warm place.
Danish: • Lad delene tørre et varmt sted.
English: If you forget to use Nasonex
Danish: Hvis du har glemt at bruge Nasonex
English: Epistaxis Nasal burning Nasal irritation Nasal ulceration
Danish: Brændende fornemmelse i næsen Irritation i næsen Nasal ulceration
English: Point the nozzle away from you and then press down with your fingers to pump the spray 10 times until a fine mist is produced.
Danish: Peg tuden væk fra dig selv og tryk derefter ned for at pumpe 10 gange, til der fremkommer en fin forstøvning.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON NASONEX 50 µg/actuation 60 and 140 actuations
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton - Nasonex 50 µg/dosis - 60 og 140 doser
English: If you stop using Nasonex
Danish: Hvis du holder op med at bruge Nasonex
English: Efficacy and Safety studies of NASONEX Nasal Spray for the treatment of nasal polyposis were four months in duration.
Danish: Der er udført effekt- og sikkerhedsstudier med Nasonex næsespray af 4 måneders varighed i forbindelse med behandling af nasale polypper.
English: Nasonex contains benzalkonium chloride which may cause nasal irritation.
Danish: Nasonex næsespray indeholder benzalkoniumchlorid, som kan medføre nasal irritation.
English: • 4.2 Posology and method of administration
Danish: 4.2 Dosering og indgivelsesmåde
English: NAME OF THE MEDICINAL PRODUCT [See Annex I - To be completed nationally] mometasone furoate
Danish: LÆGEMIDLETS NAVN [Se bilag I - Udfyldes nationalt] mometasonfuroat
English: Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods.
Danish: Der kan forekomme systemiske virkning efter brug af nasale kortikosteroider, specielt ved ordination af høje doser over længere perioder.
English: The usual recommended starting dose for polyposis is two actuations (50 micrograms/actuation) in each nostril once daily (total daily dose of 200 micrograms).
Danish: Den almindelige anbefalede startdosis ved behandling af polypper er to pust (50 mikrogram/pust) i hvert næsebor en gang dagligt (total daglig dosis 200 mikrogram).
English: Nasonex reduces the swelling and irritation in your nose and thereby relieving sneezing, itching and a blocked-up or runny nose caused by hay fever or perennial rhinitis.
Danish: Nasonex mindsker hævelse og irritation i næsen og lindrer nysen, kløe og tilstoppet (tæt) eller løbenæse fremkaldt af høfeber eller helårssnue.
English: Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods.
Danish: Der kan forekomme systemiske virkninger efter brug af nasale kortikosteroider, især ved høje doser ordineret i længere perioder.
English: If symptoms are inadequately controlled, the dose may be increased to a maximum daily dose of four actuations in each nostril once daily (total dose 400 micrograms).
Danish: Hvis symptomerne ikke er velbehandlede, kan dosis øges til den maksimale daglige dosering på fire pust i hvert næsebor én gang dagligt (totaldosis 400 mikrogram).
English: Nasonex Nasal Spray contains mometasone furoate, one of a group of medicines called corticosteroids.
Danish: Nasonex næsespray indeholder det aktive stof mometasonfuroat, som tilhører en gruppe af medicin kaldet binyrebarkhormoner (kortikosteroider).
English: No statistically significant dose-response relationship was detected for any of the tumour types.
Danish: For ingen af disse tumorer fandtes der nogen statistisk signifikant dosis-respons sammenhæng.
English: Children between the ages of 3 and 11 years: The usual recommended dose is one actuation (50 micrograms/actuation) in each nostril once daily (total dose 100 micrograms).
Danish: Børn i alderen 3 - 11 år: Den sædvanligt anbefalede dosis er et pust (50 mikrogram/pust) i hvert næsebor én gang dagligt (totaldosis 100 mikrogram).
English: If the pump is not used for 14 days or longer, reprime the pump with 2 actuations until a uniform spray is observed, before next use.
Danish: Hvis pumpen ikke har været brugt de seneste 14 dage eller længere, skal pumpen reaktiveres ved at trykke 2 gange på pumpen inden brug, til der ses en ensartet forstøvning.
English: What you need to know before you use Nasonex
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT BRUGE NASONEX
English: Do not use Nasonex if you are allergic (hypersensitive) to mometasone furoate or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for mometasonfuroat eller et af de øvrige indholdsstoffer i Nasonex (angivet i punkt 6).
English: If symptoms are not controlled after 5 to 6 weeks, the dose may be increased to two sprays in each nostril twice daily.
Danish: • Hvis der ikke ses bedring af symptomerne efter 5 til 6 uger, kan dosis øges til 2 pust i hvert næsebor 2 gange dagligt.
English: Seasonal Allergic or Perennial Rhinitis
Danish: Sæsonbetinget allergisk rhinitis eller helårsrhinitis.
English: The safety and efficacy of NASONEX Nasal Spray in children and adolescents under 18 years of age have not been established.
Danish: Nasale polypper Sikkerheden og virkningen af Nasonex næsespray hos børn og unge under 18 år er ikke klarlagt.
English: NASONEX Nasal Spray is indicated for use in adults and children 3 years of age and older to treat the symptoms of seasonal allergic or perennial rhinitis.
Danish: Nasonex næsespray er indiceret til symptomatisk behandling af voksne og børn på 3 år og derover med sæsonbetinget rhinitis eller helårsrhinitis.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger.
English: If no improvement in symptoms is seen after 5 to 6 weeks of twice daily administration, you should contact your doctor.
Danish: • Hvis du ikke oplever en bedring efter 5 - 6 uger med anvendelse to gange om dagen, skal du tale med din læge.
English: When used at high doses for long periods of time, corticosteroid nasal sprays may cause certain sideeffects, such as slowed growth rate in children.
Danish: Når børn bruger næsespray med binyrebarkhormoner i høje doser og i længere tid, kan det medføre visse bivirkninger, f.eks. langsom vækst.
English: 6.6 Special precautions for disposal and other handling
Danish: 6.6 Regler for destruktion og anden håndtering Ingen særlige forholdsregler.
English: This medicinal product contains 0.02 mg of benzalkonium chloride per actuation.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Dette lægemiddel indeholder 0,02 mg benzalkoniumchlorid per/dosis.
English: After using the spray, wipe the nozzle carefully with a clean handkerchief or tissue and replace the dust cap.
Danish: Tør forsigtig tuden af efter brug med et rent lommetørklæde eller serviet og sæt støvhætten på igen.
English: This leaflet was last approved in [To be completed nationally]
Danish: Denne indlægsseddel blev senest revideret: [Udfyldes nationalt]
English: What Nasonex contains
Danish: Nasonex indeholder:
English: Perennial rhinitis occurs throughout the year and symptoms can be caused by a sensitivity to a variety of things including house dust mite, animal hair (or dander), feathers and certain foods.
Danish: Symptomerne kan stamme fra overfølsomhed over for mange forskellige ting f.eks. husstøvmider, dyrehår (eller skæl), fjer og bestemte fødevarer.
English: You should not use the nasal spray until your nose has healed.
Danish: Du skal vente med at bruge næsesprayen, indtil infektionen er overstået.
English: Always use Nasonex exactly as your doctor has told you.
Danish: Brug altid Nasonex nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: Talk to your doctor or pharmacist before using Nasonex if you have or have ever had tuberculosis.
Danish: Kontakt lægen eller apotekspersonalet, før du bruger Nasonex.
English: None known.
Danish: Ingen kendt påvirkning.
English: NASONEX Nasal Spray is indicated for the treatment of nasal polyps in adults 18 years of age and older.
Danish: Nasonex næsespray er indiceret til behandling af nasale polypper hos voksne patienter på 18 år og derover.
English: SPECIAL STORAGE CONDITIONS [To be completed nationally]
Danish: 6.4 Særlige opbevaringsforhold [Udfyldes national]
English: Remove the dust cap and gently pull off the nozzle.
Danish: • Tag støvhætten af og træk forsigtigt tuden af.
English: If after 5 to 6 weeks symptoms are inadequately controlled, the dose may be increased to a daily dose of two sprays in each nostril twice daily (total daily dose of 400 micrograms).
Danish: Hvis symptomerne ikke er tilstrækkeligt kontrollerede efter 5 til 6 uger, kan dosis øges til to pust (50 mikrogram/pust) i hvert næsebor to gange daglig (total daglig dosis 400 mikrogram).
English: The spray will need to be primed again with 2 sprays when first used after cleaning.
Danish: • Inden sprayen bruges igen efter rengøringen, skal den klargøres ved at pumpe 2 gange.
English: A few people may find that once they discontinue oral or injected corticosteroids they suffer from some undesirable effects, such as joint or muscular pain, weakness and depression.
Danish: Nogle få personer kan, når de stopper behandlingen med binyrebarkhormoner gennem munden (f.eks. tabletter) eller ved indsprøjtning, opleve at få bivirkninger så som led- eller muskelsmerter, følelse af mathed og depression.
English: 60 actuations
Danish: 60 doser
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL NASONEX 50 µg/actuation 60 and 140 actuations
Danish: ETIKET Nasonex 50 µg/dosis - 60 og 140 doser
English: Hypersensitivity to the active substance, mometasone furoate, or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller overfor et eller flere af hjælpestofferne anført i pkt.
English: Nasal polyps Nasonex is used to treat nasal polyps in adults aged 18 and over.
Danish: Nasonex bruges til at behandle næsepolypper hos voksne på 18 år og derover.
English: Other medicines and Nasonex Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: PHARMACEUTICAL FORM AND CONTENTS Nasal Spray Suspension
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Næsespray
English: However, some people, after using Nasonex or other corticosteroid nasal sprays, may find that they suffer from:
Danish: De fleste har ikke nogen problemer efter brug af næsesprayen, men nogle personer har efter brug af Nasonex eller andre kortikosteroid-næsesprays oplevet at få:
English: Following 12 months of treatment with NASONEX Nasal Spray in a study of patients with perennial rhinitis, there was no evidence of atrophy of the nasal mucosa; also, mometasone furoate tended to reverse the nasal mucosa closer to a normal histologic phenotype.
Danish: Efter 12 måneders behandling med Nasonex næsespray i et studie med patienter med helårsrhinitis fandtes ingen tegn på atrofi af næseslimhinden.
English: if you are taking other corticosteroid medicines, either by mouth or by injection.
Danish: • hvis du tager anden medicin, som indeholder binyrebarkhormoner enten gennem munden (f.eks.
English: Hayfever, which occurs at certain times of the year, is an allergic reaction caused by breathing in pollen from trees, grasses, weeds and also moulds and fungal spores.
Danish: Reaktionen udløses, når man indånder pollen fra træer, græsser, ukrudt samt sporer fra skimmel og svampe.
English: The usual dose is one spray into each nostril once daily.
Danish: Den sædvanlige dosis er 1 pust i hvert næsebor 1 gang dagligt.
English: Table 1:
Danish: (Figur 1)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each metered actuation delivers 50 µg mometasone furoate.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En dosis indeholder: 50 mikrogram mometasonfuroat
English: Nasonex reduces the inflammation in the nose, causing the polyps to gradually shrink, thereby relieving a blocked feeling in the nose which may affect breathing through the nose.
Danish: Nasonex mindsker betændelsestilstanden (inflammationen) i næsen, og får derved polypperne til gradvist at svinde ind.
English: The usual starting dose is two sprays into each nostril once daily.
Danish: Den sædvanlige startdosis er 2 pust i hvert næsebor 1 gang dagligt.
English: Cleaning your nasal spray
Danish: Klargøring af næsesprayen
English: Annex III
Danish: (Figur 3)