FrancophonIA/ELRC3.0 huggingface dataset:
English: The carcinogenicity potential of inhaled mometasone furoate (aerosol with CFC propellant and surfactant) at concentrations of 0.25 to 2.0 micrograms/l was investigated in 24-month studies in mice and rats.
Danish: Det karcinogene potentiale af inhaleret mometasonfuroat (aerosol med CFC drivgas og surfaktant) ved koncentrationer på 0,25 til 2,0 mikrogram/l blev undersøgt i 24-måneders undersøgelser på mus og rotter.
English: Remove the nozzle from this nostril and breathe out through the mouth.
Danish: Fjern tuden fra dette næsebor og pust ud gennem munden.
English: There is little or no information on the use of Nasonex in pregnant women.
Danish: Der findes kun få eller ingen oplysninger om brugen af Nasonex hos gravide kvinder.
English: All observed effects are typical of this class of compounds and are related to exaggerated pharmacologic effects of glucocorticoids.
Danish: Alle de observerede virkninger fandtes typiske for denne gruppe af stoffer og var relaterede til glukokortikoiders farmakologiske virkninger.
English: There are no clinical data concerning the effect of mometasone furoate on fertility.
Danish: Der foreligger ingen kliniske data vedrørende mometasonfuroats indvirkning på fertilitet.
English: Treatment with higher than recommended doses may result in clinically significant adrenal suppression.
Danish: Behandling med højere doser end de anbefalede kan forårsage klinisk signifikant binyrebarksuppression.
English: Biotransformation The small amount that may be swallowed and absorbed undergoes extensive first-pass hepatic metabolism.
Danish: Biotransformation Den ringe mængde, som evt. synkes og absorberes, undergår udtalt "first pass"-metabolisering i leveren.
English: Remember to take this off before using the spray and to replace it after use.
Danish: Husk at tage denne hætte af før brug og at sætte den på igen efter brug.
English: In clinical studies, epistaxis occurred at a higher incidence compared to placebo.
Danish: I kliniske studier forekom epistaxis med højere incidens end med placebo.
English: Disturbances of taste and smell
Danish: • forandringer i smags- eller lugtesans
English: Animal studies have shown reproductive toxicity, but no effects on fertility (see section 5.3).
Danish: Dyrestudier har påvist reproduktionstoksicitet, men ingen indvirkning på fertilitet (se pkt.
English: If you use steroids for a long time or in large amounts they may, rarely, affect some of your hormones.
Danish: Hvis du bruger binyrebarkhormoner i lang tid eller i store mængder, kan disse i sjældne tilfælde påvirke nogen af dine hormoner.
English: Wash the nozzle and dust cap in warm water and then rinse under a running tap.
Danish: • Vask tuden og støvhætten i varmt vand og skyl herefter under rindende vand.
English: Mometasone furoate significantly inhibits the release of leukotrienes from leucocytes of allergic patients.
Danish: Mometasonfuroat har en signifikant hæmmende effekt på frigørelsen af leukotriener fra leukocytter hos allergiske patienter.
English: Mometasone furoate, administered as an aqueous nasal spray, has a systemic bioavailability of <1% in plasma, using a sensitive assay with a lower quantitation limit of 0.25 pg/ml.
Danish: Mometasonfuroat givet som en vandig nasalspray har en systemisk biotilgængelighed på < 1 % i plasma ved brugen af en følsom metode med en nedre kvantificeringsgrænse på 0,25 pg/ml.
English: In a study involving 48 children aged 3 to 5 years treated with intranasal mometasone furoate 50, 100 or 200 µg/day for 14 days, there was no significant differences from placebo in the mean change in plasma cortisol level in response to the tetracosactrin stimulation test.
Danish: I en undersøgelse omfattende 48 børn fra 3 til 5 år, behandlet med intranasal mometasonfuroat 50, 100 eller 200 mikrogram/dag i 14 dage, var der ingen signifikante forskelle fra placebo i gennemsnitlig ændring af plasmakortisolniveauet som reaktion på tetracosactin stimulationstest.
English: • Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på pakningen.
English: Increased intraocular pressure
Danish: Forhøjet intraokulært tryk
English: Such transfer may also unmask pre-existing allergic conditions, such as allergic conjunctivitis and eczema, previously suppressed by systemic corticosteroid therapy.
Danish: Et sådant skift kan også afsløre skjulte allergiske tilstande såsom allergisk konjunktivit og eksem, som har været undertrykt af den systemiske kortikosteroidbehandling.
English: • Unilateral polyps that are unusual or irregular in appearance, especially if ulcerating or bleeding, should be further evaluated.
Danish: Unilaterale polypper, der ser usædvanlige eller uregelmæssige ud, bør undersøges nærmere, specielt hvis der er sår eller blødning.
English: Dose reduction is recommended following control of symptoms.
Danish: Dosisreduktion anbefales, når symptomerne er under kontrol.
English: Although NASONEX Nasal Spray will control the nasal symptoms in most patients, the concomitant use of appropriate additional therapy may provide additional relief of other symptoms, particularly ocular symptoms.
Danish: Selvom Nasonex næsespray kan kontrollere nasale symptomer hos de fleste patienter, kan samtidig anvendelse af passende tillægsbehandling give yderligere lindring af andre symptomer, især okulære symptomer.
English: Potential systemic effects may include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
Danish: Eventuelle systemiske virkninger kan omfatte Cushings syndrom, cushingoide træk, binyrebarksuppression, væksthæmning hos børn og unge, katarakt, glaukom og sjældnere, en række psykiske eller adfærdsrelaterede bivirkninger, inklusive psykomotorisk hyperaktivitet, søvnforstyrrelser, angst, depression og aggression (specielt hos børn).
English: Preclinical studies demonstrate that mometasone furoate is devoid of androgenic, antiandrogenic, estrogenic or antiestrogenic activity but, like other glucocorticoids, it exhibits some antiuterotrophic activity and delays vaginal opening in animal models at high oral doses of 56 mg/kg/day and 280 mg/kg/day.
Danish: Prækliniske undersøgelser har vist, at mometasonfuroat er uden androgene, antiandrogene, østrogene eller antiøstrogene virkninger, men som andre glukokortikoider har det nogen antiuterotrofisk virkning og forsinker den vaginale åbning i dyreforsøg ved højere perorale doser på 56 mg/kg/dag og 280 mg/kg/dag.
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 forsinkes, bør behandlingen revurderes med det formål om muligt at reducere dosis af nasal kortikosteroid til den laveste dosis, ved hvilken effektiv symptomkontrol er opretholdt.
English: It is unknown whether mometasone furoate is excreted in human milk.
Danish: Det er ukendt, om mometasonfuroat udskilles i human mælk.
English: Patients receiving corticosteroids who are potentially immunosuppressed should be warned of the risk of exposure to certain infections (e.g., chickenpox, measles) and of the importance of obtaining medical advice if such exposure occurs.
Danish: Patienter, der får kortikosteroider og potentielt er immunsupprimerede, bør advares om risikoen ved udsættelse for visse infektioner (fx skoldkopper og mæslinger) og vigtigheden af at søge læge, hvis de bliver udsat for smitte.
English: White to off-white opaque suspension.
Danish: LÆGEMIDDELFORM Næsespray, suspension Hvid til off-white uigennemsigtig suspension.
English: Elimination Absorbed mometasone furoate is extensively metabolized and the metabolites are excretedin urine and bile.
Danish: Elimination Absorberet mometasonfuroat metaboliseres ekstensivt, og metabolitterne udskilles med urin og galde.
English: In a placebo-controlled clinical trial in which paediatric patients (n=49/group) were administered NASONEX Nasal Spray 100 micrograms daily for one year, no reduction in growth velocity was observed.
Danish: I en placebokontrolleret klinisk undersøgelse, i hvilken pædiatriske patienter (n = 49/gruppe) fik administreret Nasonex næsespray 100 mikrogram daglig i et år, sås ingen reduktion i væksthastigheden.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For nasal use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til brug i næsen.
English: Repeat step 4 to inhale a second spray in the same nostril if applicable.
Danish: Gentag trin 4 for at få 1 dosis mere i samme næsebor, hvis det er relevant.
English: It is important to clean your nasal spray regularly, otherwise it may not work properly.
Danish: • Det er vigtigt at rense næsesprayen regelmæssigt, da der ellers er risiko for, at sprayen ikke virker optimalt.
English: Treatment related adverse reactions (≥1%) reported in clinical trials in patients with allergic rhinitis or nasal polyposis and post-marketing regardless of indication are presented in Table 1.
Danish: Behandlingsrelaterede bivirkninger (≥1%), som er blevet rapporteret i kliniske studier hos patienter med allergisk rhinitis eller nasale polypper samt efter markedsføring uanset indikation, fremgår af tabel 1.
English: (See 4.4 Special warnings and special precautions for use with systemic corticosteroids)
Danish: 4.4 ”Særlige advarsler og forsigtighedsregler vedrørende brugen af systemiske kortikosteroider”).
English: The bottle should be discarded after the labelled number of actuations or within 2 months of first use.
Danish: Beholderen skal smides væk efter de på pakningen anførte antal doser eller senest 2 måneder efter første anvendelse.
English: At the end of the pollen season your hayfever symptoms should get better and treatment may then not be needed.
Danish: I slutningen af pollensæsonen skulle du gerne kunne føle en forbedring i dine høfebersymptomer, og måske behøver du ikke længere behandlingen.
English: Like other glucocorticoids, mometasone furoate showed a clastogenic potential in-vitro at high concentrations.
Danish: Som ved andre glukokortikoider udviste mometasonfuroat et klastogent potentiale in vitro ved høje koncentrationer.
English: Because the systemic bioavailability of NASONEX Nasal Spray is <1%, overdose is unlikely to require any therapy other than observation, followed by initiation of the appropriate prescribed dosage.
Danish: Da den systemiske biotilgængelighed for Nasonex næsespray er < 1,0 % er det usandsynligt, at en overdosis vil kræve andet end observation efterfulgt af en genoptagelse af den foreskrevne dosis.
English: If these patients exhibit signs and symptoms of adrenal insufficiency or symptoms of withdrawal (e.g., joint and/or muscular pain, lassitude, and depression initially) despite relief from nasal symptoms, systemic corticosteroid administration should be resumed and other modes of therapy and appropriate measures instituted.
Danish: Hvis disse patienter udviser symptomer på binyrebarkinsufficiens eller withdrawal-symptomer (fx led- og/eller muskelsmerter, udmattelse og depression i starten) på trods af lindring af de nasale symptomer, bør den systemiske kortikosteroidbehandling genoptages og andre behandlingsformer eller forholdsregler indledes.
English: In patients treated for nasal polyposis, the overall incidence of adverse events was similar to that observed for patients with allergic rhinitis.
Danish: Hos patienter, der blev behandlet for nasale polypper, var den samlede bivirkningsfrekvens den samme, som blev observeret hos patienter med allergisk rhinitis.
English: Infants born of mothers who received corticosteroids during pregnancy should be observed carefully for hypoadrenalism.
Danish: Spædbørn, hvis mor har fået kortikosteroider under graviditeten, skal observeres omhyggeligt for binyrebarkinsufficiens.
English: Pharmacotherapeutic group: Decongestants and Other Nasal Preparations for Topical Use-Corticosteroids, ATC code: R01A D09
Danish: Farmakoterapeutisk klassifikation: Kortikosteroider til lokal anvendelse, ATC-kode: R 01 AD 09
English: In addition, it is an extremely potent inhibitor of the production of the Th2 cytokines, IL-4 and IL-5, from human CD4+ T-cells.
Danish: Herudover udviser mometasonfuroat også en særdeles potent hæmning af produktionen af Th2-cytokiner, IL-4 og IL-5 fra humane CD4+T-celler.
English: If you or your child suffer badly from hayfever, your doctor may tell you to start using Nasonex before the start of the pollen season, as this will help to prevent your hayfever symptoms from occurring.
Danish: Hvis du eller dit barn lider voldsomt af høfeber, kan din læge anbefale dig at bruge Nasonex før pollensæsonen starter, for på denne måde at forhindre høfebersymptomer i at opstå.
English: Hypersensitivity including anaphylactic reactions, angioedema, bronchospasm, and dyspnoea
Danish: Overfølsomhed herunder anafylaktiske reaktioner, angioødem, bronkospasmer og dyspnø
English: Do not try to unblock the nasal applicator by inserting a pin or other sharp object as this will damage the applicator and cause you not to get the right dose of medicine.
Danish: • Forsøg ikke at fjerne blokeringer ved at indsætte en nål eller andre spidse genstande, da dette vil skade tuden og dermed forårsage ukorrekt dosering af medicinen.
English: Put your forefinger and middle finger either side of the nozzle and your thumb underneath the bottle.
Danish: Placér pegefingeren og langfingeren på hver side af tuden og tommelfingeren i bunden af flasken.
English: In some patients Nasonex should begin to relieve symptoms 12 hours after the first dose; however full benefit of treatment may not be seen for up to two days.
Danish: Hos nogle patienter begynder Nasonex at lindre symptomerne 12 timer efter første dosis; men der kan gå op til 2 dage før en fuld virkning af behandlingen ses.
English: • The active substance is mometasone furoate.
Danish: • Aktivt stof: mometasonfuroat.
English: Use of Nasonex during an untreated infection in your nose, such as herpes, can worsen the infection.
Danish: Hvis du bruger Nasonex, mens du har en ubehandlet infektion i næsen, så som herpes, kan det forværre infektionen.
English: If no improvement in symptoms is seen after 5 to 6 weeks of twice daily administration, the patient should be re-evaluated and treatment strategy reconsidered.
Danish: Hvis der ikke ses bedring i symptomerne efter 5 - 6 uger med administration to gange dagligt, bør patienten revurderes, og behandlingsstrategien genovervejes.
English: Following the use of intranasal corticosteroids, instances of increased intraocular pressure have been reported (see section 4.8).
Danish: Efter anvendelse af nasale kortikosteroider er der rapporteret tilfælde af øget intraokulært tryk (se pkt.
English: Nevertheless, patients using NASONEX Nasal Spray over several months or longer should be examined periodically for possible changes in the nasal mucosa.
Danish: Patienter, som anvender Nasonex næsespray gennem flere måneder eller længere, bør dog undersøges regelmæssigt for mulige ændringer i næseslimhinden.
English: Inhalation or oral administration of excessive doses of corticosteroids may lead to suppression of HPA axis function.
Danish: Inhalation eller oral administration af meget store doser kortikosteroider kan føre til suppression af hypothalamus-hypofyse-binyrebarkaksen.
English: Nasal polyps are small growths on the lining of the nose and usually affect both nostrils.
Danish: Næsepolypper er små gevækster på næseslimhinden og findes sædvanligvis i begge næsebor.
English: There are limited data available on the safety and efficacy of NASONEX Nasal Spray in the paediatric population aged 3 to 5 years, and an appropriate dosage range cannot be established.
Danish: Der er begrænsede data til rådighed vedrørende sikkerhed og effekt af Nasonex næsespray hos børn i alderen 3 til 5 år, og et passende doseringsinterval kan ikke fastsættes.
English: Once your symptoms are under control, your doctor may advise you to decrease the dose.
Danish: Når dine symptomer er under kontrol, kan din læge anbefale dig at nedsætte dosis.
English: Gently shake the bottle.
Danish: Ryst flasken let.
English: The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Danish: Dosis skal titreres til den lavest mulige dosis, hvor symptomkontrol kan opretholdes.
English: If your eyes are itching or irritated, your doctor may recommend that you use other treatments with Nasonex.
Danish: Hvis øjnene klør eller er irriterede, kan lægen råde dig til at bruge anden behandling sammen med Nasonex.
English: INFORMATION IN BRAILLE Nasonex 50 µg nasal spray [To be completed nationally]
Danish: INFORMATION I BRAILLE-SKRIFT nasonex 50 mikrogram næsespray [Udfyldes nationalt]
English: Treatment-related adverse reactions reported by system organ class and frequency Very common
Danish: Tabel 1: Behandlingsrelaterede bivirkninger rapporteret i henhold til systemorganklasse og hyppighed
English: Each spray contains 50 micrograms of mometasone furoate, as the monohydrate.
Danish: Hvert pust indeholder 50 mikrogram mometasonfuroat som monohydrat.
English: Like other glucocorticoids, mometasone furoate is a teratogen in rodents and rabbits.
Danish: Som andre glukokortikoider er mometasonfuroat teratogent hos gnavere og kaniner.
English: As with other nasal corticosteroid preparations, NASONEX Nasal Spray should not be used in pregnancy unless the potential benefit to the mother justifies any potential risk to the mother, foetus or infant.
Danish: Som med andre nasale kortikosteroidpræparater bør Nasonex næsespray ikke anvendes under graviditet med mindre de potentielle fordele for moderen opvejer de mulige risici for moderen, fosteret eller spædbarnet.
English: The safety and efficacy of NASONEX Nasal Spray has not been studied for use in the treatment of unilateral polyps, polyps associated with cystic fibrosis, or polyps that completely obstruct the nasal cavities.
Danish: Sikkerheden og virkningen af Nasonex næsespray er ikke blevet undersøgt ved behandling af unilaterale polypper, polypper forbundet med cystisk fibrose eller polypper, der fuldstændigt lukker næsehulen.
English: In the paediatric population, the incidence of recorded adverse events in clinical studies, e.g., epistaxis (6%), headache (3%), nasal irritation (2%) and sneezing (2%) was comparable to placebo.
Danish: I den pædiatriske population var hyppigheden af rapporterede bivirkninger, så som epistaxis (6 %), hovedpine (3 %), nasal irritation (2 %) og nysen (2 %), sammenlignelig med placebo i kliniske studier.
English: You may also seem to develop other allergies, such as itchy, watering eyes or patches of red and itchy skin.
Danish: Du kan også udvikle andre allergiske symptomer, som kløende øjne der løber i vand eller steder med rød eller kløende hud.
English: Typical glucocorticoid-related effects, including several non-neoplastic lesions, were observed.
Danish: I disse undersøgelser observeredes de typiske glukokortikoidrelaterede virkninger herunder også adskillige ikke-neoplastiske forandringer.
English: Distribution Not applicable as mometasone is poorly absorbed via the nasal route.
Danish: Distribution Ikke relevant da mometason absorberes dårligt via næsen.
English: There were also reductions in maternal body weight gains, effects on foetal growth (lower foetal body weight and/or delayed ossification) in rats, rabbits and mice, and reduced offspring survival in mice.
Danish: Der var også en reduktion i vægtøgningen hos den drægtige, indvirkning på fostertilvæksten (lavere fostervægt og/eller forsinket ossifikation) hos rotter, kaniner og mus samt nedsat overlevelse for musens unger.
English: Persistence of nasopharyngeal irritation may be an indication for discontinuing NASONEX Nasal Spray.
Danish: Vedvarende nasopharyngeal irritation kan være en indikation for seponering af Nasonex næsespray .
English: Dispersable cellulose (microcrystalline cellulose and carmellose sodium) Glycerol
Danish: Mikrokrystallinsk cellulose og carmellosenatrium (dispergibel cellulose) Glycerol
English: After initial priming of the NASONEX Nasal Spray pump, each actuation delivers approximately 100 mg of mometasone furoate suspension, containing mometasone furoate monohydrate equivalent to 50 micrograms mometasone furoate.
Danish: Efter klargøring af spraypumpen i Nasonex næsespray giver hvert pust ca. 100 mg mometasonfuroatsuspension indeholdende mometasonfuroatmonohydrat svarende til 50 mikrogram mometasonfuroat.
English: In 28% of the patients with seasonal allergic rhinitis, NASONEX Nasal Spray demonstrated a clinically significant onset of action within 12 hours after the first dose.
Danish: Hos 28 % af patienter med sæsonbetinget allergisk rhinitis udviste Nasonex næsespray en klinisk betydende virkning inden for 12 timer efter den første dosis.
English: NASONEX Nasal Spray should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, or in untreated fungal, bacterial, or systemic viral infections.
Danish: Nasonex næsespray skal anvendes med forsigtighed, hvis overhovedet, til patienter med aktiv eller latent luftvejstuberkulose, ubehandlede svampeinfektioner, bakterielle eller systemiske virale infektioner.
English: Use in adults over 18 years old
Danish: Brug til voksne og unge over 18 år
English: In studies utilising nasal antigen challenge, NASONEX Nasal Spray has shown anti-inflammatory activity in both the early- and late- phase allergic responses.
Danish: I undersøgelser med nasal antigen-provokation har Nasonex næsespray udvist antiinflammatorisk aktivitet i såvel den tidlige som den sene fase af det allergiske respons.
English: There are no or limited amount of data from the use of mometasone furoate in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af mometasonfuroat til gravide kvinder.
English: Your Nasonex Nasal Spray has a dust cap which protects the nozzle and keeps it clean.
Danish: Din Nasonex næsespray har en støvhætte, som beskytter tuden (forstøveren) og holder den ren.
English: There is no known information on the effect of Nasonex on the ability to drive or use machinery.
Danish: Trafik- og arbejdssikkerhed Der foreligger ikke oplysninger om, at Nasonex påvirker evnen til at køre bil og betjene maskiner.
English: Prior to administration of the first dose, shake container well and actuate the pump 10 times (until a uniform spray is obtained).
Danish: Før administration af den første dosis rystes beholderen omhyggeligt, og der trykkes 10 gange på pumpen (indtil der ses en ensartet forstøvning).
English: Upper respiratory tract infection†
Danish: Faryngitis Øvre luftvejsinfektion†
English: Mometasone furoate (as the monohydrate) 50 micrograms/actuation.
Danish: Mometasonfuroat (som monohydrat) 50 mikrogram/dosis.
English: NASONEX Nasal Spray demonstrated a clinically significant onset of action within 12 hours after the first dose in some patients with seasonal allergic rhinitis; however, full benefit of treatment may not be achieved in the first 48 hours.
Danish: Nasonex næsespray giver en klinisk signifikant effekt inden for 12 timer efter den første dosis hos nogle patienter med sæsonbetinget allergisk rhinitis, mens fuldstændig gavn af behandlingen måske ikke opnås inden for de første 48 timer.
English: Once symptoms are under control, your doctor may advise you to decrease your dose.
Danish: • Når symptomerne er under kontrol, kan lægen råde dig til at nedsætte dosis.
English: Shake container well before each use.
Danish: Ryst beholderen omhyggeligt før hver anvendelse.
English: (Figure 2) Tilt your head forward slightly, keeping the bottle upright.
Danish: Læn hovedet en anelse fremad og hold flasken lodret.