FrancophonIA/ELRC3.0 huggingface dataset:
English: SINGULAIR contains aspartame, a source of phenylalanine.
Danish: SINGULAIR indeholder aspartam, som er en phenylalaninkilde.
English: Very rare cases of Churg-Strauss Syndrome (CSS) have been reported during montelukast treatment in asthmatic patients (see section 4.4).
Danish: I meget sjældne tilfælde er der rapporteret Churg-Strauss Syndrom (CSS) hos astmapatienter i behandling med montelukast (se pkt.
English: Pharmacotherapeutic group: Leukotriene receptor antagonist ATC-code: R03D C03
Danish: ATC-kode: R03D C03
English: • Oral SINGULAIR is not meant to treat acute asthma attacks.
Danish: • SINGULAIR-tabletter er ikke beregnet til behandling af akutte astmaanfald.
English: Montelukast has been shown to cross the placental barrier and is excreted in breast milk of animals.
Danish: Montelukast er vist at passere placentabarrieren og udskilles i modermælken hos dyr.
English: Efficacy data from clinical trials in paediatric patients 6 months to 2 years of age with persistent asthma are limited.
Danish: Dataene vedrørende virkning fra kliniske undersøgelser af pædiatriske patienter i alderen 6 måneder til 2 år med persistent astma er begrænsede.
English: • Your child should not take acetyl-salicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make his/her asthma worse.
Danish: • Deres barn bør ikke tage acetylsalicylsyre (aspirin), hvis astmaen bliver værre af aspirin eller anden nonsteroid anti-inflammatorisk medicin (visse former for smertestillende medicin).
English: - the CHMP concluded that the Marketing Authorisation could be harmonised for Singulair 4mg Granules ( previously known as Oral Granules) for patients aged 6 months to 5 years on the following indications:
Danish: - CHMP konkluderede, at markedsføringstilladelsen kunne harmoniseres for Singulair 4 mg granulat (tidligere kendt som oralt granulat) til patienter i alderen 6 måneder til 5 år med følgende indikationer:
English: • SINGULAIR granules are not intended to be dissolved in liquid.
Danish: • SINGULAIR granulat er ikke beregnet til at blive opløst i væske.
English: Simultaneously, the MAH updated module 3 was updated to CTD format in this referral procedure.
Danish: Samtidig blev det af indehaveren af markedsføringstilladelsen ajourførte afsnit 3 opdateret til CTD-format (Comparative Toxicogenomics Database) i denne procedure for indbragte sager.
English: • If your child's asthma or breathing gets worse, tell your doctor immediately.
Danish: • Fortæl det straks til lægen, hvis Deres barns astma eller vejrtrækning bliver værre.
English: Take special care with SINGULAIR
Danish: Vær ekstra forsigtig med at tage SINGULAIR
English: 4 mg chewable tablets are available as an alternative formulation for paediatric patients 2 to 5 years of age.
Danish: Der fås 4 mg tyggetabletter som alternativ formulering til patienter fra 2-5 år.
English: In animal studies, montelukast did not affect fertility or reproductive performance at systemic exposure exceeding the clinical systemic exposure by greater than 24-fold.
Danish: I dyreforsøg påvirkede montelukast ikke fertilitet eller reproduktionsevne ved systemisk påvirkning >24 gange højere end klinisk systemisk påvirkning.
English: SINGULAIR chewable tablets contain aspartame, a source of phenylalanine.
Danish: SINGULAIR tyggetabletter indeholder aspartam, en phenylalaninkilde.
English: What SINGULAIR is and what it is used for Before SINGULAIR is taken How to take SINGULAIR Possible side effects
Danish: SINGULAIRs virkning og hvad De skal bruge det til Det skal De vide, før Deres barn begynder at tage SINGULAIR Sådan skal Deres barn tage SINGULAIR Bivirkninger
English: Montelukast (10 mg once daily at bedtime) was shown to improve respiratory functions, reduce asthma symptoms and beta-agonist use, and to improve quality of life as compared to placebo.
Danish: Det blev påvist, at montelukast (10 mg 1 x dagligt ved sengetid) forbedrede vejrtrækningsfunktionen, mindskede astmasymptomerne og anvendelsen af beta-agonister og forbedrede den daglige livskvalitet sammenlignet med placebo.
English: The treatment effect by montelukast is smaller than that achieved with fluticasone, but the difference is small enough to be clinically not significant, and it can be compensated with better treatment compliance due to oral, once daily administration of montelukast as opposed to twice-daily inhalation of fluticasone.
Danish: Behandlingseffekten med montelukast er mindre end den, der opnås med fluticason, men forskellen er lille nok til ikke at være klinisk signifikant, og der kan kompenseres for den med bedre behandlingscompliance p.gr.a.
English: [TO BE COMPLETED NATIONALLY]
Danish: [Udfyldes nationalt]
English: The following drug-related adverse reactions in clinical studies were reported commonly (≥1/100 to <1/10) in patients treated with montelukast and at a greater incidence than in patients treated with placebo:
Danish: Følgende lægemiddelrelaterede bivirkninger i kliniske undersøgelser er rapporteret som almindelige (≥1/100 til <1/10) hos astmapatienter behandlet med montelukast og med en højere incidens end hos patienter behandlet med placebo:
English: This leaflet was last approved in {DD.MM.YYYY.}
Danish: Denne indlægsseddel blev senest godkendt {MM/ÅÅÅÅ }
English: In studies in rabbits, a higher incidence of incomplete ossification, compared with concurrent control animals, was seen at systemic exposure >24-fold the clinical systemic exposure seen at the clinical dose.
Danish: I undersøgelser med kaniner sås højere forekomst af ukomplet ossifikation sammenlignet med kontrolgruppen ved systemisk påvirkning >24 gange større end den kliniske, systemiske påvirkning set ved klinisk dosis.
English: If your child takes more SINGULAIR than he/she should Contact your child's doctor immediately for advice.
Danish: Hvis Deres barn har taget for meget SINGULAIR Kontakt straks barnets læge for at få rådgivning.
English: SINGULAIR granules are not intended to be dissolved in liquid for administration.
Danish: SINGULAIR granulat er ikke beregnet til at blive opløst i væske før administration.
English: Montelukast may be administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma.
Danish: Montelukast kan administreres samtidig med anden profylaktisk og kronisk behandling af astma.
English: PHARMACEUTICAL FORM AND CONTENTS 7, 10, 14, 20, 28, 30, 49, 50, 56, 98, 100, 140, 200 chewable tablets.
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 7, 10, 14, 20, 28, 30, 49, 50, 56, 98, 100, 140, 200 tyggetabletter
English: No dosage adjustment is necessary for patients with renal insufficiency, or mild to moderate hepatic impairment.
Danish: Justering af dosis er ikke nødvendig hos patienter med nyreinsufficiens eller mildt til moderat nedsat leverfunktion.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS SINGULAIR 4 mg tablets - Blister
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS SINGULAIR 4 mg tabletter - Blister
English: Cardiac disorders: palpitations.
Danish: Hjerte: Palpitationer.
English: Averaged over the 12-month treatment period, the percentage of asthma RFDs increased from 61.6 to 84.0 in the montelukast group and from 60.9 to 86.7 in the fluticasone group.
Danish: I løbet af den 12 måneders behandlingsperiode øgedes procentdelen af anfaldsfrie dage gennemsnitligt fra 61,6 til 84,0 i montelukastgruppen og fra 60,9 til 86,7 i fluticasongruppen.
English: After administration of the 4 mg chewable tablet to paediatric patients 2 to 5 years of age in the fasted state, Cmax is achieved 2 hours after administration.
Danish: Efter administration af 4 mg tyggetablet til fastende, pædiatriske patienter i alderen 2-5 år, nås Cmax efter 2 timer.
English: 10 mg film-coated tablets in approximately 4000 adult patients 15 years of age and older
Danish: • 10 mg filmovertrukne tabletter hos ca. 4000 voksne astmapatienter i alderen 15 år og opefter
English: If your child stops taking SINGULAIR
Danish: Hvis Deres barn har taget for meget SINGULAIR
English: In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flu-like illness, pins and needles or numbness of arms and legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome) have been reported.
Danish: Hos astmatiske patienter, der er behandlet med montelukast, er der set meget sjældne tilfælde af en kombination af allergiske symptomer med influenzalignende sygdom, stikkende og prikkende fornemmelse eller følelsesløshed i arme og ben, og /eller udslæt (Churg-Strauss syndrom).
English: • tiredness, restlessness, agitation including aggressive behaviour, irritability, tremor, depression, suicidal thoughts and actions (in very rare cases), dizziness, drowsiness, hallucinations, dream abnormalities, including nightmares and trouble sleeping, pins and needles/numbness, seizure;
Danish: • Træthed, rastløshed, ophidselse med aggressiv adfærd, irritabilitet, rysten, depression, selvmordstanker og -adfærd (i meget sjældne tilfælde), svimmelhed, døsighed, hallucinationer, ændret drømmemønster med mareridt, søvnløshed, stikkende og prikkende fornemmelser/følelsesløshed, kramper.
English: In a 12-month study comparing the efficacy of montelukast to inhaled fluticasone on asthma control in paediatric patients 6 to 14 years of age with mild persistent asthma, montelukast was non-inferior to fluticasone in increasing the percentage of asthma rescue-free days (RFDs), the primary endpoint.
Danish: I en 12-måneders undersøgelse, hvor effektiviteten af montelukast ved astmakontrol hos pædiatriske patienter i alderen 6-14 med mild vedvarende astma blev sammenlignet med inhaleret fluticason, var montelukast ikke-inferiør i forhold til fluticason til øgning af procentdelen af anfaldsfrie dage, der er det primære endpoint.
English: In rare cases, patients on therapy with anti-asthma agents including montelukast may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with ChurgStrauss syndrome, a condition which is often treated with systemic corticosteroid therapy.
Danish: I sjældne tilfælde ses hos patienter, i behandling med anti-astmapræparater, inklusive montelukast, systemisk eosinofili, nogle gange med kliniske tegn på vaskulitis, svarende til Churg-Strauss syndrom.
English: Skin and subcutaneous tissue disorders: angiooedema, bruising, urticaria, pruritus, rash, erythema nodosum.
Danish: Hud og subkutane væv: Angioødem, blå mærker, urticaria, pruritus, udslæt, erythema nodosum.
English: The SPCs proposed by the MAH were those approved through the MRP in the "old" member states and in CY and IS.
Danish: De produktresuméer, som indehaveren af markedsføringstilladelsen foreslog, var de samme, som var godkendt gennem proceduren for gensidig anerkendelse i de "gamle" medlemslande og i Cypern og Island.
English: 10 mg film-coated tablets are available for adults 15 years of age and older.
Danish: Der fås 10 mg filmovertrukne tabletter til voksne fra 15 år og opefter.
English: Studies in rats have shown that montelukast is excreted in milk (see section 5.3).
Danish: Dyreundersøgelser med rotter har vist, at montelukast udskilles i dyrenes modermælk (se pkt.
English: Blisters in packages of: 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140 and 200 tablets.
Danish: Blister i pakker med 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140 og 200 tabletter.
English: The between group difference in LS means was significant: 7.3% with a 95%CI of 2.9; 11.7.
Danish: Forskellen mellem grupperne i LS-middeløgning var signifikant: 7,3% med 95% konfidensinterval på 2,9; 11,7.
English: Please tell your doctor or pharmacist if your child is taking or has recently taken other medicines, including those obtained without a prescription.
Danish: Fortæl det altid til lægen eller apoteket, hvis Deres barn bruger anden medicin eller har brugt det for nylig.
English: Compared with inhaled beclomethasone (200 µg twice daily with a spacer device), montelukast demonstrated a more rapid initial response, although over the 12-week study, beclomethasone provided a greater average treatment effect (% change from baseline for montelukast vs beclomethasone, respectively for FEV1: 7.49% vs 13.3%; β-agonist use: -28.28% vs -43.89%).
Danish: Sammenlignet med inhalationsbeclomethason (200 µg, 2 gange dagligt med spacer) viste montelukast hurtigere initial respons, selvom beclomethason ved 12-ugers undersøgelsen gav større gennemsnitlig behandlingseffekt (%-ændring fra baseline for montelukast versus beclomethason henholdsvis for FEV1: 7,49% versus 13,3%; brug af β-agonist: -28,28% versus -43,89%).
English: Additionally, the following side effects were reported in clinical studies with either SINGULAIR 10 mg film-coated tablets, 5 mg or 4 mg chewable tablets:
Danish: Derudover er følgende bivirkninger set i kliniske undersøgelser med SINGULAIR 10 mg filmovertrukne tabletter og 5 mg eller 4 mg tyggetabletter:
English: In 2 to 5 year old patients, exercise-induced bronchoconstriction may be the predominant manifestation of persistent asthma that requires treatment with inhaled corticosteroids.
Danish: Hos patienter i alderen 2 til 5 år er anstrengelsesudløst bronkokonstriktion muligvis den fremherskende manifestation af vedvarende astma, der kræver behandling med inhalerede kortikosteroider.
English: The MAH provided harmonised modules 3 in CTD format for Singulair 4 mg granules and 4 mg chewable tablets.
Danish: Indehaveren af markedsføringstilladelsen fremlagde et harmoniseret afsnit 3 i CTD-format for Singulair 4 mg granulat og 4 mg tyggetabletter.
English: For the 10 mg film-coated tablet, the mean peak plasma concentration (Cmax) is achieved 3 hours (Tmax) after administration in adults in the fasted state.
Danish: Den gennemsnitlige peak plasmakoncentration (Cmax) opnås, for den 10 mg filmovertrukne tablet, 3 timer (Tmax) efter administration hos fastende voksne.
English: Therefore the final revised indication for 4mg CT and 4mg OG is as follows:
Danish: Derfor er den endelige reviderede indikation for 4 mg tyggetabletter og 4 mg oralt granulat som følger:
English: Cartons of 7, 20, 28 and 30 sachets.
Danish: Pakninger à 7, 20, 28 og 30 breve.
English: • increased bleeding tendency, bruising, tender red lumps under the skin most commonly on your shins (erythema nodosum), palpitations;
Danish: • Øget blødningstendens, blå mærker, knuderosen (ømme, røde knuder under huden oftest på skinnebenene), hjertebanken.
English: In aspirin-sensitive asthmatic patients receiving concomitant inhaled and/or oral corticosteroids, treatment with montelukast, compared with placebo, resulted in significant improvement in asthma control (FEV1 8.55% vs -1.74% change from baseline and decrease in total β-agonist use -27.78% vs 2.09% change from baseline).
Danish: Hos aspirinfølsomme astmapatienter, der samtidig fik inhalations- og/eller orale kortikosteroider, resulterede behandling med montelukast, sammenlignet med placebo, i signifikant forbedring i astmakontrollen (FEV1 8,55% versus -1,74% ændring fra baseline og fald i total brug af β-agonist27,78% versus 2,09% ændring fra baseline).
English: The between-group difference in LS mean increase in FEV1 was -0.02 L with a 95% CI of -0.06, 0.02.
Danish: Forskellen mellem grupperne i LS-middeløgning i FEV1 var 0,02 L med 95% konfidensinterval på0,06, 0,02.
English: Studies in adults demonstrated the ability of montelukast to add to the clinical effect of inhaled corticosteroid (% change from baseline for inhaled beclomethasone plus montelukast vs beclomethasone, respectively for FEV1: 5.43% vs 1.04%; β-agonist use: -8.70% vs 2.64%).
Danish: Undersøgelser hos voksne viste montelukasts evne til at supplere den kliniske effekt af inhalationskortikosteroider (%-ændring fra baseline for inhalationsbeclomethason plus montelukast versus beclomethason, henholdsvis for FEV1: 5,43% versus 1,04%; brug af β-agonist: -8,70% versus 2,64%).
English: In a 12-month, placebo-controlled study in paediatric patients 2 to 5 years of age with mild asthma and episodic exacerbations, montelukast 4 mg once daily significantly (p≤0.001) reduced the yearly rate of asthma exacerbation episodes (EE) compared with placebo (1.60 EE vs. 2.34 EE, respectively), [EE defined as ≥3 consecutive days with daytime symptoms requiring β-agonist use, or corticosteroids (oral or inhaled), or hospitalization for asthma].
Danish: I en 12-måneders, placebo-kontrolleret undersøgelse med pædiatriske patienter i alderen 2-5 år med mild astma og periodiske eksacerbationer reducerede montelukast 4 mg en gang dagligt den årlige forekomst af periodiske astmaeksacerbationer signifikant (p≤0,001) sammenlignet med placebo (henholdsvis 1,60 periodiske eksacerbationer versus 2,34 periodiske eksacerbationer), [periodiske eksacerbationer defineret som ≥3 på hinanden følgende dage med symptomer i dagtimerne, hvor det var nødvendigt med anvendelse af β-agonist, eller kortikosteroider (oralt eller inhaleret), eller indlæggelse på grund af astma].
English: Paediatric Patients 2 to 5 years old (one 12-week study; n=461) (one 48-week study; n=278)
Danish: Pædiatriske patienter 2-5 år (Én 12-ugers undersøgelse; n=461) (Én 48 ugers undersøgelse; n=278)
English: The difference in LS means for the change from baseline in the % predicted FEV1 was significant: -2.2% with a 95% CI of -3.6, -0.7.
Danish: Forskellen mellem grupperne i LS-middeløgning for ændringen fra baseline i FEV1 forudsagt i procent var signifikant:2,2% med 95% konfidensinterval på -3,6, -0,7.
English: The most frequently occurring symptoms reported with overdose in adults and children included abdominal pain, sleepiness, thirst, headache, vomiting, and hyperactivity.
Danish: De mest almindelige symptomer set i forbindelse med overdosering hos voksne og børn er: Mavesmerter, søvnighed, tørst, hovedpine, opkastning og hyperaktivitet.
English: Additionally, the following side effect was reported in clinical studies with SINGULAIR 10 mg filmcoated tablets and 5 mg chewable tablets:
Danish: Derudover er følgende bivirkninger seti kliniske undersøgelser med SINGULAIR 10 mg filmovertrukne tabletter og 5 mg tyggetabletter:
English: • SINGULAIR granules can be taken without regard to the timing of food intake.
Danish: • SINGULAIR granulat kan tages uden hensyn til tidspunktet for indtagelse af mad.
English: Asthma includes:
Danish: SINGULAIR indeholder:
English: SINGULAIR may be used in breast-feeding mothers only if it is considered to be clearly essential.
Danish: SINGULAIR bør kun bruges af ammende kvinder, såfremt det skønnes klart nødvendigt.
English: These important pro-asthmatic mediators bind to cysteinyl leukotriene receptors (CysLT) found in the human airway and cause airway actions, including bronchoconstriction, mucous secretion, vascular permeability, and eosinophil recruitment.
Danish: CysLT type 1 (CysLT1) receptorer findes i de humane luftveje og forårsager en række påvirkninger i luftvejene, blandt andet bronkokonstriktion, mucussekretion, karpermeabilitet og eosinofil recruitment.
English: • Store in the original package in order to protect from light and moisture.
Danish: • Opbevares i den originale yderpakning for at beskytte med lys og fugt.
English: Use in pregnancy
Danish: Graviditet og amning
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉERNE, ETIKETTERINGEN OG INDLÆGSSEDLEN
English: What SINGULAIR looks like and contents of the pack 4 mg SINGULAIR chewable tablets are pink, oval, biconvex with SINGULAIR engraved on one side and MSD 711 on the other.
Danish: SINGULAIR 4 mg tyggetabletter er lyserøde, ovale og bikonvekse med "SINGULAIR" præget på den ene side og "MSD 711" på den anden side.
English: The between group difference in LS mean increase in the percentage of asthma RFDs was statistically significant (2.8 with a 95% CI of -4.7, -0.9), but within the limit pre-defined to be clinically not inferior.
Danish: Forskellen mellem grupperne i LS-middeløgning i procentdel af astmaanfaldsfrie dage var -2,8 med 95% konfidensinterval på -4,7, -0,9, som var helt inden for den foruddefinerede grænse for at være klinisk ikke-inferiør.
English: For children 6 months to 5 years of age: One sachet of SINGULAIR 4 mg granules to be taken by mouth each evening.
Danish: Børn (6 måneder til 5 år): Ét brev SINGULAIR 4 mg granulat, der skal tages gennem munden hver aften.
English: The between group difference in LS means for the percentage of days with β-agonist use was significant: 2.7 with a 95% CI of 0.9, 4.5.
Danish: Forskellen mellem grupperne i LS-middeløgning for procentdelen af dage med anvendelse af β-agonist var signifikant: 2,7 med 95% konfidensinterval på 0,9, 4,5.
English: Respiratory, thoracic, and mediastinal disorders asthma
Danish: Luftveje, thorax og mediastinum
English: Montelukast, compared with placebo, decreased peripheral blood eosinophils in adult and paediatric patients.
Danish: Sammenlignet med placebo, nedsætter montelukast eosinofiler i det perifere blod hos voksne og børn.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: 6.6 Regler for destruktion <og anden håndtering> Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinier.
English: SINGULAIR 4 mg chewable tablets should not be taken immediately with food; they should be taken at least 1 hour before or 2 hours after food.
Danish: SINGULAIR 4 mg tyggetabletter må ikke tages sammen med mad men skal tages mindst 1 time før eller 2 timer efter et måltid.
English: In studies in adults, montelukast, 10 mg once daily, compared with placebo, demonstrated significant improvements in morning FEV1 (10.4% vs 2.7% change from baseline), AM peak expiratory flow rate (PEFR) (24.5 L/min vs 3.3 L/min change from baseline), and significant decrease in total β-agonist use (-26.1% vs -4.6% change from baseline).
Danish: I undersøgelser hos voksne viste montelukast 10 mg, en gang dagligt, sammenlignet med placebo, signifikant forbedring i morgen FEV1 (10,4% versus 2,7% ændring fra baseline), morgenekspiratorisk peak flow hastighed (PEFR) (24,5 l/min versus 3,3 l/min ændring fra baseline) og signifikant fald i total brug af β-agonist (-26,1% versus -4,6% ændring fra baseline).
English: Mannitol, microcrystalline cellulose, hyprolose (E 463), red ferric oxide (E 172), croscarmellose sodium, cherry flavour, aspartame (E951), and magnesium stearate.
Danish: rød jernoxid (E172), croscarmellosenatrium, kirsebæraroma, aspartam (E951) og magnesiumstearat.
English: In a 12-week, placebo-controlled study in paediatric patients 2 to 5 years of age, montelukast 4 mg once daily improved parameters of asthma control compared with placebo irrespective of concomitant controller therapy (inhaled/nebulized corticosteroids or inhaled/nebulized sodium cromoglycate).
Danish: I en 12-ugers, placebo-kontrolleret undersøgelse med pædiatriske patienter i alderen 2-5 år, forbedrede montelukast 4 mg, en gang dagligt, parametrene for astmakontrol sammenlignet med placebo, også ved samtidig kontrolbehandling (inhalations-/autohalerkortikosteroider eller inhalations/autohalercromoglycat).
English: No dosage adjustment is necessary for the elderly or mild to moderate hepatic insufficiency.
Danish: Dosisjustering er ikke nødvendig hos ældre patienter eller patienter med mild til moderat leverinsufficiens.
English: • SINGULAIR is used for the treatment of 6 months to 5 year old patients who are not adequately controlled on their medication and need additional therapy.
Danish: • SINGULAIR er til behandling af patienter i alderen 6 måneder-5 år, der ikke er tilstrækkeligt behandlet med deres nuværende medicin, og som har brug for yderligere behandling.