FrancophonIA/ELRC3.0 huggingface dataset:
English: Montelukast sodium has been used for the add-on treatment (concomitantly with inhaled steroids) and to prevent exercise-induced bronchoconstriction.
Danish: Montelukastnatrium er blevet anvendt som tillægsbehandling (samtidig med inhalerede steroider) og for at forebygge anstrengelsesudløst bronkokonstriktion.
English: However, the Applicant/MAH only seeks to maintain the indication for montelukast as monotherapy in mild to moderate persistent asthma in children aged 2 years to 5 years.
Danish: Imidlertid ansøger ansøgeren/indehaveren af markedsføringstilladelsen kun om at bevare indikationen for montelukast som monoterapi ved mild til moderat persisterende astma hos børn i alderen 2 til 5 år.
English: In chronic asthma studies, montelukast has been administered at doses up to 200 mg/day to adult patients for 22 weeks and in short term studies, up to 900 mg/day to patients for approximately one week without clinically important adverse experiences.
Danish: I undersøgelser hos patienter med kronisk astma er montelukast administreret i doser på op til 200 mg daglig til voksne patienter i 22 uger, og i korttidsundersøgelser i doser på op til 900 mg daglig til patienter i ca. 1 uge, uden klinisk signifikante hændelser.
English: It is not known whether montelukast is dialyzable by peritoneal- or hemo-dialysis.
Danish: Det vides ikke, om montelukast kan dialyseres ved peritoneal- eller hæmodialyse.
English: even if their symptoms are the same as your child's.
Danish: Det kan være skadeligt for andre, selvom de har de samme symptomer, som Deres barn har.
English: The percentage reduction in yearly EE rate was 31.9%, with a 95% CI of 16.9, 44.1.
Danish: Reduktion af årlig forekomst af periodiske eksacerbationer var 31,9%, med 95% konfidensinterval på 16,9, 44,1.
English: Immune system disorders: hypersensitivity reactions including anaphylaxis, hepatic eosinophilic infiltration.
Danish: Immunsystemet: Hypersensitivitetsreaktioner inklusive anafylaksi og hepatisk eosinofilinfiltration.
English: However, if your child misses a dose, just resume the usual schedule of one tablet once daily.
Danish: Hvis De har glemt at give Deres barn en dosis, skal De blot genoptage behandlingen og fortsætte med én tablet én gang dagligt.
English: In animal toxicity studies, minor serum biochemical alterations in ALT, glucose, phosphorus and triglycerides were observed which were transient in nature.
Danish: Der er i dyretoksicitetsundersøgelser observeret mindre serum-biokemiske forandringer af kortvarig natur i ALAT, glucose, phosphor og triglycerider.
English: If your child is taking SINGULAIR, be sure that your child does not take any other products that contain the same active ingredient, montelukast.
Danish: Hvis Deres barn tager SINGULAIR, må barnet ikke få andre lægemidler, som indeholder samme aktive stof, montelukast.
English: The Applicant/MAH also made reference to an original application concerning 5 mg CT, which presented the results of a study in 336 paediatric patients (age 6 to 14 years).
Danish: Ansøgeren/indehaveren af markedsføringstilladelsen henviste også til en oprindelig ansøgning vedrørende 5 mg tyggetabletter, hvor resultaterne fra en undersøgelse med 336 pædiatriske patienter (i alderen 6-14 år) blev fremlagt.
English: SINGULAIR granules can be administered either directly in the mouth, or mixed with a spoonful of cold or room temperature soft food (e.g., applesauce, ice cream, carrots and rice).
Danish: SINGULAIR granulat kan administreres enten direkte i munden eller blandet med en skefuld koldt eller tempereret, blødt fødemiddel (f.eks. æblemos, is, gulerødder eller ris).
English: Moreover the MAH submitted a proposal for harmonised chemical-pharmaceutical sections of the SPC and PL.
Danish: Desuden indsendte indehaveren af markedsføringstilladelsen et forslag til harmoniserede og kemisk-farmaceutiske afsnit i produktresuméet og indlægssedlen.
English: The present referral procedure sought harmonisation of the product information for Singulair 4 mg chewable tablets and 4 mg oral granules with the indications already approved for children 2-5 years old and 6 months to 2 years old in Mutual Recognition Procedures, with Finland acting as the reference member state.
Danish: Formålet med denne procedure for indbragte sager var at harmonisere produktoplysningerne for Singulair 4 mg tyggetabletter og 4 mg oralt granulat med de indikationer, der allerede er godkendt for børn i alderen 2-5 år og 6 måneder til 2 år via proceduren for gensidig anerkendelse, hvor Finland fungerer som referencemedlemsstat.
English: Your doctor will determine how SINGULAIR should be used depending on the symptoms and severity of your child's asthma.
Danish: Deres læge vil beslutte, hvordan Deres barn skal anvende SINGULAIR afhængigt af symptomerne, og hvor alvorlig astmaen er.
English: These were usually mild and occurred at a greater frequency in patients treated with SINGULAIR than placebo (a pill containing no medication).
Danish: Disse bivirkninger var normalt milde og sås hyppigere hos patienter, der var behandlet med SINGULAIR end hos patienter, der fik placebo (tablet uden virkning).
English: “Merck Sharp & Dohme”, UAB, Kestucio str. 59/27 LT-08124 Vilnius Lithuania
Danish: “Merck Sharp & Dohme”, UAB, Kestucio str. 59/27 LT-08124 Vilnius Lithauen
English: The Applicant/MAH also made reference to an original application concerning the 10 mg film-coated tablet and 5 mg CT, which presents the results of two placebo-controlled clinical studies in more than 1600 adult patients with mild-to-moderate asthma.
Danish: Ansøgeren/indehaveren af markedsføringstilladelsen henviste også til en oprindelig ansøgning vedrørende 10 mg filmovertrukne tabletter og 5 mg tyggetabletter, hvor resultaterne af to placebokontrollerede kliniske undersøgelser med mere end 1.600 voksne patienter med mild til moderat astma blev fremlagt.
English: The Applicant/MAH provided supportive documentation for this indication of 4mg OG in children aged 6 month to 2 years based on pharmacokinetic data PN 136/138, supportive safety data PN 176, and the extrapolation of efficacy to this age group from the efficacy demonstrated in older children (25 years old, 6-14 years old) according to ICH E11 guideline.
Danish: Ansøgeren/indehaveren af markedsføringstilladelsen fremlagde dokumentation til støtte for denne indikation på 4 mg oralt granulat hos børn i alderen 6 måneder til 2 år på grundlag af farmakokinetiske data PN 136/138, underbyggende sikkerhedsdata PN 176 og effektekstrapoleringen for denne aldersgruppe fra den effekt, der påvistes hos større børn (2-5 år og 6-14 år) i henhold til retningslinjerne fra den internationale harmoniseringskonference (ICH) E11.
English: There are no data on patients with severe hepatic impairment.
Danish: Der er ingen data vedrørende patienter med svært nedsat leverfunktion.
English: The results of P910 suggest that with montelukast, as good benefit-risk ratio can be achieved in the treatment of paediatric mild, persistent asthma as with inhaled fluticasone.
Danish: Resultaterne fra P910 tyder på, at der kan opnås et lige så godt benefit/risk-forhold ved behandling af pædiatrisk mild, vedvarende astma med montelukast som med fluticasoninhalation.
English: The mean Cmax is 66% higher while mean Cmin is lower than in adults receiving a 10 mg tablet.
Danish: Gennemsnitlig Cmax er 66% højere, mens Cmin er mindre end hos voksne efter administration af 10 mg tabletten.
English: In studies with therapeutic doses, plasma concentrations of metabolites of montelukast are undetectable at steady state in adults and children.
Danish: I undersøgelser med terapeutiske doser er plasmakoncentrationer af montelukastmetabolitter vedvarende under detektionsgrænsen hos voksne og børn.
English: Montelukast was determined not to be phototoxic in mice for UVA, UVB or visible light spectra at doses up to 500 mg/kg/day (approximately >200-fold based on systemic exposure).
Danish: Montelukast er vist ikke at være fototoksisk hos mus ved UVA, UVB eller synligt lysspektrum ved doser på op til 500 mg/kg/dag (ca. >200 gange baseret på systemisk påvirkning).
English: If taken in connection with food, SINGULAIR should be taken 1 hour before or 2 hours after food.
Danish: Hvis præparatet indtages i forbindelse med et måltid, skal SINGULAIR tages 1 time før eller 2 timer efter fødeindtagelsen.
English: Given that the efficacy data from children aged 6 months to 2 years of age is not considered very robust, the CHMP requested, that the Applicant/MAH should give a more detailed instruction in Section 4.2 as to how the treatment effect should be monitored and evaluated.
Danish: Eftersom dokumentationen af effekten på børn i alderen 6 måneder til 2 år ikke anses for tilstrækkelig udførlig, bad CHMP ansøgeren/indehaveren af markedsføringstilladelsen om at give en mere udførlig anvisning i afsnit 4.2 på, hvorledes behandlingens effekt bør overvåges og evalueres.
English: Montelukast improved daytime symptoms (including coughing, wheezing, trouble breathing and activity limitation) and nighttime symptoms compared with placebo.
Danish: Montelukast forbedrede signifikant dagsymptomer (herunder hoste, hivende vejrtrækning, åndedrætsbesvær og indskrænket aktivitet) samt natlige symptomer i forhold til placebo.
English: • phenobarbital (used for treatment of epilepsy)
Danish: • phenobarbital (mod epilepsi)
English: The active substance in Singulair products is montelukast sodium.
Danish: Det aktive stof i Singulair-produkterne er montelukastnatrium.
English: Treatment should be discontinued if lack of response is observed.
Danish: Behandlingen bør seponeres, hvis respons udebliver.
English: Pink, oval, bi-convex-shaped, SINGULAIR engraved on one side and MSD 711 on the other.
Danish: Lyserød, oval, bikonveks, med ”SINGULAIR” indgraveret på den ene side og ”MSD 711” på den anden side.
English: The diagnosis of persistent asthma in very young children (6 months - 2 years) should be established by a paediatrician or pulmonologist.
Danish: Diagnosticering af vedvarende astma hos meget små børn (6 måneder - 2 år) skal foretages af en pædiater eller en lungespecialist.
English: SINGULAIR as an alternative treatment option to low-dose inhaled corticosteroids for mild, persistent asthma:
Danish: SINGULAIR som alternativ behandlingsmulighed til lavdosis inhalationskortikosteroid til mild vedvarende astma:
English: Patients with phenylketonuria should take into account that each 4 mg chewable tablet contains phenylalanine in an amount equivalent to 0.674 mg phenylalanine per dose.
Danish: Patienter, der lider af phenylketonuri, bør være opmærksomme på, at hver 4 mg tyggetablet indeholder phenylalanin i en mængde svarende til 0,674 mg phenylalanin pr. dosis.
English: The 4 mg granule formulation is bioequivalent to the 4 mg chewable tablet when administered to adults in the fasted state.
Danish: 4 mg granulat formuleringen er bioækvivalent med 4 mg tyggetabletten, når denne administreres til fastende voksne.
English: (Invented) name
Danish: Særnavn Navn
English: SINGULAIR is not expected to affect your ability to drive a car or operate machinery.
Danish: Det er ikke sandsynligt, at SINGULAIR påvirker evnen til at køre bil eller betjene maskiner.
English: The effect in both studies was demonstrated at the end of the once-daily dosing interval.
Danish: Effekten i begge undersøgelser blev vist i slutningen af doseringsintervallet ved dosis én gang dagligt.
English: the CHMP has recommended the amendment of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Singulair and associated names (see Annex I).
Danish: anbefalede CHMP ændring af markedsføringstilladelsen(-rne) for Singulair og tilknyttede navne (se bilag I).
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMEERNE, ETIKETTERINGEN OG INDLÆGSSEDLEN
English: Therapy with SINGULAIR in relation to other treatments for asthma.
Danish: Behandling med SINGULAIR i relation til anden astmabehandling:
English: When treatment with SINGULAIR is used as add-on therapy to inhaled corticosteroids, SINGULAIR should not be abruptly substituted for inhaled corticosteroids (see section 4.4).
Danish: Når behandling med SINGULAIR anvendes som tillæg til inhalationskortikosteroider, bør SINGULAIR ikke brat substituere inhalationskortikosteroider (se pkt.
English: No deaths occurred following a single oral administration of montelukast sodium at doses up to 5000 mg/kg in mice and rats (15,000 mg/m2 and 30,000 mg/m2 in mice and rats, respectively), the maximum dose tested.
Danish: Der sås ingen dødsfald efter oral enkeltadministration af montelukastnatrium i doser op til 5000 mg/kg hos mus og rotter (henholdsvis 15.000 mg/m2 og 30.000 mg/m2 hos mus og rotter), den maksimale testede dosis.
English: In paediatric patients 6 months to 2 years of age, Cmax is achieved 2 hours after administration of the 4 mg granules formulation.
Danish: Hos pædiatriske patienter i alderen 6 måneder til 2 år opnås Cmax 2 timer efter administration af 4 mg granulat formuleringen.
English: For children who have problems consuming a chewable tablet, a granule formulation is available (see SINGULAIR 4 mg granule SPC).
Danish: Til børn, der har problemer med at indtage en tyggetablet, findes en granulatformulering (se SPCet for SINGULAIR 4 mg granulat).
English: The possibility that leukotriene receptor antagonists may be associated with emergence of Churg-Strauss syndrome can neither be excluded nor established.
Danish: Det kan hverken udelukkes eller bekræftes, at leukotrien-receptorantagonister kan sættes i forbindelse med fremkomst af Churg-Strauss syndrom.
English: White granules
Danish: Hvidt granulat.
English: In adult and paediatric patients 2 to 14 years of age, montelukast, compared with placebo, decreased peripheral blood eosinophils while improving clinical asthma control.
Danish: Hos voksne og pædiatriske patienter i alderen 2-14 år sænkede montelukast, sammenlignet med placebo, eosinofiler i det perifere blod og forbedrede den kliniske astmakontrol.
English: For children 2 to 5 years of age:
Danish: Børn (2-5 år):
English: It is not known if montelukast is excreted in human milk.
Danish: Det vides ikke, om montelukast udskilles i human modermælk.
English: Formulations for paediatric use, 4 mg chewable tablets and 4 mg oral granules, have been available since 2000 and 2002, respectively.
Danish: Formuleringer til pædiatrisk brug, tyggetabletter 4 mg og oralt granulat har været på markedet siden henholdsvis 2000 og 2002.
English: The signs of toxicity in animals were increased excretion of saliva, gastrointestinal symptoms, loose stools and ion imbalance.
Danish: Tegn på toksicitet hos dyr var øget spytsekretion, gastrointestinale symptomer, tynd afføring og ionubalance.
English: • The active substance is montelukast.
Danish: • Aktivt stof: Montelukast.
English: FEV1 increased from 1.83 L to 2.09 L in the montelukast group and from 1.85 L to 2.14 L in the fluticasone group.
Danish: FEV1 øgedes fra 1,83 L til 2,09 L i montelukastgruppen og fra 1,85 L til 2,14 L i fluticasongruppen.
English: If your child has phenylketonuria (a rare, hereditary disorder of the metabolism) you should take into account that each 4-mg chewable tablet contains phenylalanine (equivalent to 0.674 mg phenylalanine per 4 mg chewable tablet).
Danish: Hvis Deres barn har Føllings sygdom (fenylketonuri, en sjælden, arvelig stofskiftesygdom), bør De være opmærksom på, at hver 4 mg tyggetablet indeholder phenylalanin (svarende til 0,674 mg phenylalanin per tablet).
English: The percentage of days with β-agonist use decreased from 38.0 to 15.4 in the montelukast group, and from 38.5 to 12.8 in the fluticasone group.
Danish: Procentdelen af dage med anvendelse af β-agonist faldt fra 38,0 til 15,4 i montelukastgruppen, og fra 38,5 til 12,8 i fluticasongruppen.
English: The mean increase from baseline in % predicted FEV1 was 0.6% in the montelukast treatment group, and 2.7% in the fluticasone treatment group.
Danish: Middeløgningen fra baseline i % forudsagde, at FEV1 var 0,6% i montelukastbehandlingsgruppen og 2,7% i fluticasonbehandlingsgruppen.
English: In monkeys, the adverse effects appeared at doses from 150 mg/kg/day (>232-fold the systemic exposure seen at the clinical dose).
Danish: Hos aber opstod bivirkninger ved doser fra 150 mg/kg/dag (>232 gange den systemiske påvirkning set ved klinisk dosis).
English: • phenytoin (used for treatment of epilepsy)
Danish: • phenytoin (mod epilepsi)
English: Psychiatric disorders: dream abnormalities including nightmares, hallucinations, insomnia, psychomotor hyperactivity (including irritability, restlessness, agitation including aggressive behaviour, and tremor), depression, suicidal thinking and behaviour (suicidality) in very rare cases.
Danish: Psykiske forstyrrelser: Abnorme drømme inklusive mareridt, hallucinationer, søvnløshed, psykomotorisk hyperaktivitet (inklusive irritabilitet, rastløshed, ophidselse med aggressivadfærd, tremor), depression, i meget sjældne tilfælde selvmordstanker og -adfærd (suicidal adfærd).
English: Treatment with montelukast inhibited both early- and late-phase bronchoconstriction due to antigen challenge.
Danish: Behandling med montelukast hæmmer både den tidlige og den sene fase af bronkokonstriktionen ved antigen belastning.
English: For children 2 to 5 years of age
Danish: Til børn fra 2 til 5 år.
English: Member State Marketing Authorisation Holder
Danish: Medlemsstat Indehaver af markedsføringstiladelse
English: Merck Sherp & Dohme Chaussée de Waterloo 1135 B-1180 Brussels Belgium
Danish: Merck Sherp & Dohme Chaussée de Waterloo 1135 B-1180 Brussel Belgien
English: In drug-interactions studies, the recommended clinical dose of montelukast did not have clinically important effects on the pharmacokinetics of the following medicinal products: theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol/norethindrone 35/1), terfenadine, digoxin and warfarin.
Danish: I lægemiddelinteraktionsundersøgelser havde den anbefalede, kliniske dosis af montelukast ingen signifikant klinisk effekt på farmakokinetikken i følgende lægemidler: Teofyllin, prednison, prednisolon, orale antikonceptionsmidler (etinyløstradiol/noretindron 35/1), terfenadin, digoxin og warfarin.
English: • The other ingredients are: Mannitol, hyprolose (E 463), and magnesium stearate.
Danish: • Øvrige indholdsstoffer: Mannitol, hydroxypropylcellulose (E463), og magnesiumstearat.
English: • It should be taken even when your child has no symptoms or if he/she has an acute asthma attack.
Danish: • Deres barn skal også tage tabletten, selvom barnet ikke har symptomer eller hvis han/hun har et akut astmaanfald.
English: It is not known if SINGULAIR appears in breast milk.
Danish: Man ved ikke, om SINGULAIR udskilles i modermælk.
English: Clinical Efficacy: Monotherapy of asthma
Danish: Klinisk effekt: monoterapi af astma
English: A slight decrease in pup body weight was noted in the female fertility study in rats at 200 mg/kg/day (>69-fold the clinical systemic exposure).
Danish: Der sås lille fald i afkommets kropsvægt i fertilitetsundersøgelse med hunrotter ved 200 mg/kg/dag (>69 gange klinisk, systemisk påvirkning).
English: In three active-controlled studies, in nearly 1000 adult patients with mild-to-moderate asthma, the effect of montelukast (10 mg once daily) was shown to be better than that obtained with placebo, but less than that obtained with inhaled beclometasone dipropionate (400 µg/day).
Danish: I tre aktive kontrollerede undersøgelser med næsten 1.000 voksne patienter med mild til moderat astma blev det påvist, at effekten af montelukast (10 mg 1 x dagligt) var bedre end placeboeffekten, men mindre end den, der blev opnået med beclometasondipropionat (400 µg/dag).
English: Montelukast (5 mg once daily) was shown to exert an anti-asthmatic effect that was larger than the effect obtained with placebo.
Danish: Det blev påvist, at montelukast (5 mg 1 x dagligt) havde en antiastmatisk effekt, der var større end den effekt, der blev opnået med placebo.
English: The most frequently occurring adverse experiences were consistent with the safety profile of montelukast and included abdominal pain, somnolence, thirst, headache, vomiting, and psychomotor hyperactivity.
Danish: De hyppigst observerede hændelse var konsistente ned sikkerhedsprofilen for montelukast og inkluderede abdominalsmerter, somnolens, tørst, hovedpine, opkastning og psykomotorisk hyperaktivitet.
English: - the scope of the referral was the harmonisation of the Summaries of Products Characteristics, labelling, package leaflet and Module 3.
Danish: - Formålet med indbringelsen af sagen var at harmonisere produktresuméerne, etiketteringen, indlægssedlen og afsnit 3.
English: This narrowing of airways worsens and improves in response to various conditions.
Danish: Denne forsnævring kan ændres som reaktion på forskellige forhold.
English: Bulgaria, Cyprus, Estonia, Finland, Germany, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta, Norway, Portugal, Romania, Slovenia, Spain, Sweden, United Kingdom: SINGULAIR
Danish: Dette lægemiddel er godkendt i EØS medlemslande under følgende navne: Bulgarien, Cypern, Estland, Finland, Grækenland, Irland, Island, Italien, Letland, Litauen, Luxemburg, Malta, Norge, Portugal, Rumænien, Slovenien, Spanien, Storbritannien, Sverige, Tyskland.
English: - the CHMP concluded that the Marketing Authorisation could be harmonised for Singulair 4mg Chewable Tablets for patients aged 2 to 5 years on the following indications:
Danish: - CHMP konkluderede, at markedsføringstilladelsen kunne harmoniseres for Singulair 4 mg tyggetabletter til patienter i alderen 2 til 5 år til følgende indikationer:
English: The percentage of patients with an asthma attack (an asthma attack being defined as a period of worsening asthma that required treatment with oral steroids, an unscheduled visit to the doctor's office, an emergency room visit, or hospitalization) was 32.2 in the montelukast group and 25.6 in the fluticasone group; the odds ratio (95% CI) being significant: equal to 1.38 (1.04, 1.84).
Danish: Procentdelen af patienter med et astmaanfald (hvor et astmaanfald defineres som en periode med forværret astma, som krævede behandling med orale steroider, et ikke-planlagt besøg hos lægen, et skadestuebesøg, eller indlæggelse) var 32,2 i montelukastgruppen og 25,6 i fluticasongruppen; oddsratio (95% konfidensinterval) var signifikant: svarende til 1,38 (1,04, 1,84).
English: Certain side effects (such as dizziness and drowsiness) that have been reported very rarely with SINGULAIR may affect some patients' ability to drive or operate machinery.
Danish: Der er i meget sjældne tilfælde set bivirkninger (såsom svimmelhed og døsighed) med SINGULAIR, som kan påvirke evnen til at køre bil eller betjene maskiner.
English: If you have any further questions on the use of this product, ask your child's doctor or pharmacist.
Danish: Er De i tvivl så spørg barnets læge eller apoteket.
English: Patients receiving montelukast had more days without asthma than those receiving placebo.
Danish: Patienter der fik montelukast havde flere dage uden astma end de patienter, der fik placebo.
English: The co-administration of applesauce or a high-fat standard meal with the granule formulation did not have a clinically meaningful effect on the pharmacokinetics of montelukast as determined by AUC (1225.7 vs 1223.1 ng.hr/mL with and without applesauce, respectively, and 1191.8 vs 1148.5 ng.hr/mL with and without a high-fat standard meal, respectively).
Danish: Samtidig administration af æblemos eller et fedtrigt standardmåltid og granulatformuleringen havde ingen klinisk relevant virkning på montelukasts farmakokinetik målt ved AUC (1225,7 versus 1223,1 ng·t/ml henholdsvis med og uden æblemos samt 1191,8 versus 1148,5 ng·t/ml henholdsvis med og uden fedtrigt standardmåltid).
English: Montelukast is not recommended as monotherapy in patients with moderate persistent asthma.
Danish: Montelukast frarådes som monoterapi til patienter med moderat vedvarende astma.