FrancophonIA/ELRC3.0 huggingface dataset:
English: These include reports in adults and children with a dose as high as 1000 mg (approximately 61 mg/kg in a 42 month old child).
Danish: Disse inkluderer rapporter fra voksne og børn med dosis op til 1000 mg (ca. 61 mg/kg for et 42 måneder gammelt barn).
English: No specific information is available on the treatment of overdose with montelukast.
Danish: Der er ingen specifik information om behandling af overdosering af montelukast.
English: The effect was seen over 12 weeks of therapy.
Danish: Effekten sås over 12 ugers behandling.
English: However, your child may take liquids after swallowing the SINGULAIR granules.
Danish: Men Deres barn må gerne drikke væske efter at have slugt SINGULAIR granulat.
English: Cumulatively, 502 paediatric patients 2 to 5 years of age were treated with montelukast for at least 3 months, 338 for 6 months or longer, and 534 patients for 12 months or longer.
Danish: Kumulativt behandledes 502 pædiatriske patienter i alderen 2-5 år med montelukast i mindst 3 måneder, 338 patienter i 6 måneder eller længere og 534 patienter i 12 måneder eller længere.
English: Additionally, 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: Desuden 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: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJ, ANSØGERE, INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: • Mix all of the contents of the SINGULAIR granules into a spoonful of cold or room temperature soft food, taking care to see that the entire dose is mixed with the food.
Danish: • Bland hele indholdet af brevet med SINGULAIR granulat i en skefuld koldt eller tempereret blødt mad og vær omhyggelig med at hele dosen blandes med maden.
English: Mild persistent asthma is defined as asthma symptoms more than once a week but less that once a day, nocturnal symptoms more than twice a month but less than once a week, normal lung function between episodes.
Danish: Mild vedvarende astma defineres som astmasymptomer mere end en gang om ugen men mindre end en gang om dagen, natlige symptomer mere end to gange om måneden men mindre end en gang om ugen, normal lungefunktion mellem episoderne.
English: Cmax is nearly 2-fold greater than in adults receiving a 10 mg tablet.
Danish: Cmax er næsten 2 gange højere end hos voksne, der får en 10 mg tablet.
English: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Slovak Republic, Spain, Sweden, United Kingdom
Danish: Belgien, Bulgarien, Cypern, Danmark, Estland, Finland, Grækenland, Holland, Irland, Island, Italien, Letland, Litauen, Luxemburg, Malta, Norge, Polen, Portugal, Rumænien, Slovenien, Slovakiet, Spanien, Storbritannien, Sverige, Tjekkiet, Tyskland, Ungarn, Østrig.
English: Tell your doctor about any medical problems or allergies your child has now or has had.
Danish: Fortæl Deres læge om alle helbredsproblemer, som Deres barn har nu eller har haft.
English: Box 581, 2003 PC Haarlem
Danish: P.O. Box 581, 2003 PC Haarlem
English: WHAT SINGULAIR IS AND WHAT IT IS USED FOR
Danish: SINGULAIRS VIRKNING OG HVAD DE SKAL BRUGE DET TIL
English: Coupled with estimates of montelukast oral bioavailability, this indicates that montelukast and its metabolites are excreted almost exclusively via the bile.
Danish: Sammenholdt med estimater af montelukasts orale biotilgængelighed, indikerer dette, at montelukast og dets metabolitter næsten udelukkende udskilles gennem galden.
English: Lack of effect on growth rate is also a benefit of montelukast.
Danish: Manglende effekt på væksthastighed er en yderligere fordel ved montelukast.
English: The bronchodilation effect caused by a β-agonist was additive to that caused by montelukast.
Danish: Den bronkodilaterende virkning af en β-agonist var additiv til den fremkaldt af montelukast.
English: The MAH selected the sections which presented major divergences and were the scope of the harmonisation through the referral procedure.
Danish: Indehaveren af markedsføringstilladelsen udvalgte de afsnit, hvor der var store forskelle, og som var de afsnit, der skulle harmoniseres gennem proceduren for indbragte sager.
English: General recommendations.
Danish: Generelle retningslinier:
English: The plasma clearance of montelukast averages 45 ml/min in healthy adults.
Danish: Plasmaclearance af montelukast er i gennemsnit 45 ml/min hos raske voksne.
English: This indication with regard to younger paediatric patients is largely based on these data, taking into account the pharmacokinetics of montelukast (rapid absorption) and data in adults showing the rapid onset of effect.
Danish: Med hensyn til yngre pædiatriske patienter er denne indikation i det store og hele baseret på disse data, hvor der er taget hensyn til montelukasts farmakokinetik (hurtig absorption) og data fra voksne, der viser den hurtige indtræden af effekten.
English: By blocking leukotrienes, SINGULAIR improves asthma symptoms and helps control asthma.
Danish: Ved at blokere leukotrienernes virkning kan SINGULAIR mindske astmasymptomer og hjælpe med at kontrollere astmaen.
English: Packaged in polyamide/PVC/aluminum blister package in:
Danish: Pakket i polyamid/PVC/aluminium blisterpakning.
English: Therefore, the PDCO expressed the need to conduct studies to precisely define the patient population that should receive montelukast sodium for the treatment of mild persistent asthma.
Danish: Derfor udtrykte PDCO behovet for at udføre flere undersøgelser for præcist at definere den patientpopulation, der bør modtage montelukastnatrium til behandling af mild persisterende astma.
English: Patients should be advised never to use oral montelukast to treat acute asthma attacks and to keep their usual appropriate rescue medication for this purpose readily available.
Danish: Patienter bør informeres om aldrig at anvende montelukast oralt til behandling af akutte astmaanfald og om at holde deres sædvanlige, relevante anfaldsmedicin til rådighed til dette formål.
English: Results of P907 showed efficacy over placebo.
Danish: Resultaterne fra P907 viste en større effekt end placeboeffekten.
English: • To be taken by mouth
Danish: • Direkte i munden
English: There are no data demonstrating that oral corticosteroids can be reduced when montelukast is given concomitantly.
Danish: Der er ingen data der viser, at orale kortikosteroider kan reduceres ved samtidig administration af montelukast.
English: Further efficacy reports of two clinical studies (P176 and P072-02; double-blind, randomized, placebo-controlled, parallel group) were presented for both 4mg OG and CT formulations.
Danish: Yderligere effektrapporter fra to kliniske undersøgelser (P176 og P072-02; dobbeltblinde, randomiserede, placebokontrollerede, parallelgrupper) blev fremlagt for både formuleringen 4 mg oralt granulat og tyggetabletter.
English: Montelukast is not expected to affect a patient's ability to drive a car or operate machinery.
Danish: Montelukast forventes ikke at påvirke patientens evne til at køre bil eller betjene maskiner.
English: Studies in rats with radiolabeled montelukast indicate minimal distribution across the blood-brain barrier.
Danish: Undersøgelser med radioaktivt mærket montelukast til rotter indikerer minimal distribution over blodhjernebarrieren.
English: In double-blind, randomised studies it was also shown that the anti-asthmatic effect of montelukast can be shown against exercise-induced asthma in adults.
Danish: I dobbeltblinde, randomiserede undersøgelser blev det endvidere påvist, at den antiastmatiske effekt af montelukast kan påvises for anstrengelsesudløst astma hos voksne.
English: Study P910 (treatment duration 52 weeks) was carried out in 6 to 14-year old paediatric patients, study P907 in patients 2 to 6 years old.
Danish: Undersøgelsen P910 (behandlingsvarighed 52 uger) blev udført med pædiatriske patienter i alderen 6 til 14 år og undersøgelsen P907 med patienter i alderen 2 til 6 år.
English: There were no adverse experiences in the majority of overdose reports.
Danish: Der var ingen bivirkninger i størstedelen af overdoseringsrapporterne.
English: The wheezing observed in the younger age group could be attributed to a number of diagnoses (viral infection, RSV bronchiolitis, or early symptoms of classic asthma).
Danish: Den hivende vejrtrækning, der observeredes i den yngste aldersgruppe, kan skyldes flere diagnoser (virusinfektion, RSV, bronkiolitis eller tidlige symptomer på klassisk astma).
English: How to store SINGULAIR Further information
Danish: Sådan opbevarer De SINGULAIR Yderligere oplysninger
English: Administration of SINGULAIR granules:
Danish: Administration af SINGULAIR granulat:
English: EXCIPIENT: ASPARTAME (E 951) 1.2 MG PER TABLET.
Danish: Hjælpestof: Aspartam (E951) 1,2 mg pr. tablet.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorization Holder and Manufacturer
Danish: Indehaver af markedsføringstilladelsen og fremstiller Indehaver af markedsføringstilladelse og Fremstiller
English: These occurred at dosages which provided >17-fold the systemic exposure seen at the clinical dosage.
Danish: Disse opstod ved doser som gav >17 gange den systemiske påvirkning opnået ved klinisk dosis.
English: In vitro studies have shown that montelukast is a potent inhibitor of CYP 2C8.
Danish: In vitro-undersøgelser har vist, at montelukast er en potent hæmmer af CYP2C8.
English: Women who are pregnant or intend to become pregnant should consult their doctor before taking SINGULAIR.
Danish: Hvis De er gravid eller planlægger at blive gravid, bør De kontakte lægen, før de tager SINGULAIR.
English: Always have your child's inhaled rescue medicine for asthma attacks with you.
Danish: De skal altid have Deres barns inhalationsmedicin til astmaanfald med Dem.
English: Your doctor has prescribed SINGULAIR to treat your child's asthma, preventing asthma symptoms during the day and night.
Danish: Lægen har foreskrevet SINGULAIR til behandling af Deres barns astma og til at forhindre astmasymptomer om dagen og om natten.
English: However, data from a clinical drug-drug interaction study involving montelukast and rosiglitazone (a probe substrate representative of medicinal products primarily metabolized by CYP 2C8) demonstrated that montelukast does not inhibit CYP 2C8 in vivo.
Danish: Data fra en interaktionsundersøgelse med montelukast og rosiglitazon (et referencesubstrat repræsentativt for lægemidler primært metaboliseret af CYP2C8) har dog vist, at montelukast ikke hæmmer CYP2C8 in vivo.
English: • Your child should take only one tablet of SINGULAIR once a day as prescribed by your doctor.
Danish: • Deres barn skal kun tage én SINGULAIR tablet dagligt som foreskrevet af lægen.
English: Montelukast showed improvement in the variables of asthma as compared to placebo.
Danish: Montelukast viste forbedringer med hensyn til astmavariablerne sammenlignet med placebo.
English: The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are potent inflammatory eicosanoids released from various cells including mast cells and eosinophils.
Danish: Cysteinylleukotrienerne (LTC4, LTD4 LTE4) er potente, inflammatoriske eicosanoider, der frigøres fra diverse celler, blandt andet mastceller og eosinofiler.
English: 28027 - Madrid Spain
Danish: 28027 - Madrid Spanien
English: The safety profile in paediatric patients 6 months to 2 years of age did not change with treatment up to 3 months.
Danish: Sikkerhedsprofilen hos pædiatriske patienter i alderen 6 måneder til 2 år ændredes ikke med behandling i op til 3 måneder.
English: Montelukast should not be abruptly substituted for inhaled or oral corticosteroids.
Danish: Montelukast bør ikke brat substituere inhalations- eller orale kortikosteroider.
English: 28027- Madrid Spain
Danish: 28027- Madrid Spanien
English: The percentage of patients with systemic (mainly oral) corticosteroid use during the study period was 17.8% in the montelukast group and 10.5% in the fluticasone group.
Danish: Procentdelen af patienter med systemisk (fortrinsvis oral) anvendelse af kortikosteroid i undersøgelsesperioden var 17,8% i montelukastgruppen og 10,5% i fluticasongruppen.
English: The following sections of the SPCs were presented for harmonisation: 4.1 Therapeutic Indications, 4.2 Posology and method of administration, 4.3 Contraindications, 4.4 Special Warnings and Precautions for Use, 4.8 Undesirable effects, and 6.5 Shelf life.
Danish: Følgende afsnit i produktresuméet blev fremlagt til harmonisering: 4.1 Terapeutiske indikationer, 4.2 Dosering og indgivelsesmåde, 4.3 Kontraindikationer, 4.4 Særlige advarsler og forsigtighedsregler vedrørende brug, 4.8 Bivirkninger og 6.5 Holdbarhed.
English: In addition, concentrations of radiolabeled material at 24 hours post-dose were minimal in all other tissues.
Danish: Derudover var koncentrationerne af radioaktivt mærket materiale minimale i alle andre væv 24 timer efter administration.
English: Given that activity limitation due to asthma is difficult to assess in very young children (aged < 2 years), the Applicant/MAH revised the indication to state that it refers only to children 2 years of age or older.
Danish: Eftersom aktivitetsbegrænsning, der skyldes astma, er vanskelig at vurdere hos meget små børn (i alderen < 2 år), ændrede ansøgeren/indehaveren af markedsføringstilladelsen indikationerne, så der kun henvises til børn på 2 år eller derover.
English: Improvement in patient-reported daytime and nighttime asthma symptoms scores was significantly better than placebo.
Danish: Forbedring i patientrapporteret dag- og natastmasymptom-score var signifikant bedre end med placebo.
English: In a separate study, treatment with montelukast significantly decreased eosinophils in the airways (as measured in sputum).
Danish: I en separat undersøgelse nedsatte behandling med montelukast signifikant eosinofiler i luftvejene (målt i sputum).
English: Also IS and NO have granted marketing authorisation to this formulation.
Danish: Også Island og Norge har udstedt markedsføringstilladelse for denne formulering.
English: Since montelukast is metabolised by CYP 3A4, caution should be exercised, particularly in children, when montelukast is coadministered with inducers of CYP 3A4, such as phenytoin, phenobarbital and rifampicin.
Danish: Da montelukast metaboliseres via CYP3A4, bør der, især hos børn, udvises forsigtighed, når montelukast administreres samtidig med CYP3A4-induktorer, som phenytoin, phenobarbital og rifampicin.
English: Given the lack of efficacy data for this indication in patients younger than 2 years, the CHMP consulted with the Paediatric Committee regarding the extrapolation of data from studies conducted in older paediatric patients to assess the safety/efficacy of montelukast in very young paediatric patients.
Danish: Da der ikke foreligger dokumentation for virkningen af lægemidlet anvendt til denne indikation hos børn under 2 år, rådførte CHMP sig med Det Pædiatriske Udvalg om ekstrapolering af data fra undersøgelser af ældre pædiatriske patienter med henblik på at vurdere sikkerheden/virkningen af montelukast hos meget unge pædiatriske patienter.
English: SINGULAIR may be used during pregnancy only if it is considered to be clearly essential.
Danish: SINGULAIR bør kun bruges under graviditet, såfremt det skønnes klart nødvendigt.
English: In a trend voting after the Applicant/MAH's Oral Explanation, the majority of the CHMP (26+2 positive, 3 negative votes) was in favour of accepting the indication as proposed by the Applicant/MAH, including the treatment of very young patients (6 months to 2 year old) when diagnosis of persistent asthma has been established.
Danish: I en tendensafstemning efter en mundtlig forklaring fra ansøgeren/indehaveren af markedsføringstilladelsen var majoriteten af CHMP (26+2 stemmer for, 3 stemmer imod) for at godkende indikationen som foreslået af ansøgeren/indehaveren af markedsføringstilladelsen, herunder behandling af meget små børn (6 måneder til 2 år), når diagnosen vedvarende astma er stillet.
English: For children who have problems consuming a chewable tablet, an oral granule formulation is available.
Danish: Til børn, der har problemer med at tage en tyggetablet, findes et oralt granulat.
English: • It is important that your child take all asthma medications prescribed by your doctor.
Danish: • Det er vigtigt, at Deres barn tager den astmamedicin, som lægen har udskrevet.
English: Aspartame (E 951)
Danish: Aspartam (E951)
English: • asthma
Danish: • Astma
English: With high doses of montelukast (20- and 60-fold the recommended adult dose), a decrease in plasma theophylline concentration was observed.
Danish: Ved høje doser af montelukast (20 og 60 gange den anbefalede voksendosis) sås fald i plasmateofyllinkoncentrationen.
English: One 4 mg chewable tablet daily to be taken in the evening.
Danish: Én 4 mg tyggetablet dagligt, der skal tages om aftenen.
English: Since 2002, the MRP indications also include the monotherapy of 4 mg paediatric formulations in the treatment of mild asthma in exceptional cases, i.e. when inhaled corticosteroids cannot be used.
Danish: Siden 2002 omfatter MRP-indikationerne også monoterapi med pædiatriske formuleringer med 4 mg til behandling af mild astma i særlige tilfælde, dvs. når inhalerede kortikosteroider ikke kan bruges.
English: Tatoiou Street, Nea Erythrea, 146 71, Greece
Danish: Grækenland VIANEX A.E. Tatoiou Street, Nea Erythrea, 146 71, Grækenland
English: • Be sure the child is given the entire spoonful of the granule/food mixture immediately (within
Danish: • Man skal sikre sig, at barnet straks får hele skefulden af granulat/madblandingen (inden for 15 minutter).
English: Box 214
Danish: P.O. Box 214
English: SINGULAIR is a leukotriene receptor antagonist that blocks substances called leukotrienes.
Danish: SINGULAIR er en leukotrienreceptor-antagonist, der blokerer visse stoffer (leukotriener) i kroppen.
English: PHARMACEUTICAL FORM Granules.
Danish: LÆGEMIDDELFORM Granulat.
English: Safety and efficacy were demonstrated in clinical trials where the 10 mg film-coated tablet was administered without regard to the timing of food ingestion.
Danish: Sikkerhed og effekt er vist i kliniske undersøgelser, hvor den 10 mg filmovertrukne tablet administreredes uden hensyn til tidspunktet for fødeindtag.
English: However, compared with beclomethasone, a high percentage of patients treated with montelukast achieved similar clinical responses (e.g., 50% of patients treated with beclomethasone achieved an improvement in FEV1 of approximately 11% or more over baseline while approximately 42% of patients treated with montelukast achieved the same response).
Danish: Sammenlignet med beclomethason, opnåede en høj procentdel af patienter behandlet med montelukast imidlertid samme kliniske respons (det vil sige 50% af patienterne behandlet med beclomethason opnåede en forbedring i FEV1 på ca. 11% eller mere over baseline, mens ca. 42% af patienterne behandlet med montelukast opnåede samme respons).
English: Because montelukast and its metabolites are eliminated by the biliary route, no dose adjustment is anticipated to be necessary in patients with renal impairment.
Danish: Da montelukast og dets metabolitter elimineres via galden, er dosisjustering ikke nødvendig hos patienter med nedsat nyrefunktion.
English: SINGULAIR should not be used instead of other asthma medications your doctor has prescribed for your child.
Danish: SINGULAIR må ikke erstatte eventuel anden medicin mod astma, som lægen har udskrevet til Deres barn.
English: Based on further in vitro results in human liver microsomes, therapeutic plasma concentrations of montelukast do not inhibit cytochromes P450 3A4, 2C9, 1A2, 2A6, 2C19, or 2D6.
Danish: Baseret på yderligere in vitro-resultater i humane levermikrosomer, hæmmer terapeutiske plasmakoncentrationer af montelukast ikke cytokrom P450 3A4, 2C9, 1A2, 2A6, 2C19 eller 2D6.
English: • SINGULAIR also helps prevent the narrowing of airways triggered by exercise for patients 2 years of age and older.
Danish: • SINGULAIR hjælper også til at forebygge forsnævring af luftvejene ved fysisk aktivitet hos patienter i alderen 2 år og ældre.
English: Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients.
Danish: Lægen bør være opmærksom på eosinofili, vaskulitisk udslæt, forværrede pulmonære symptomer, kardielle komplikationer og/eller neuropati hos patienterne.
English: Studies in patients with renal impairment have not been undertaken.
Danish: Der er ikke udført undersøgelser hos patienter med nyreinsufficiens.
English: If satisfactory response is not achieved, an additional or different therapy should be considered.
Danish: Hvis der ikke er opnået tilfredsstillende respons, bør det overvejes at give en tillægsbehandling eller en anden behandling.
English: The area under the plasma concentration curve (AUC) for montelukast was decreased approximately 40% in subjects with co-administration of phenobarbital.
Danish: Hos forsøgspersoner faldt arealet under plasmakoncentrationskurven (AUC) for montelukast med ca. 40% ved samtidig administration af phenobarbital.
English: Montelukast was neither mutagenic in in vitro and in vivo tests nor tumorigenic in rodent species.
Danish: Montelukast var hverken mutagent i in vitro- eller in vivo-undersøgelser eller tumorgent hos gnavere.
English: Montelukast is extensively metabolized.
Danish: Montelukast metaboliseres meget hurtigt.
English: In vitro studies using human liver microsomes indicate that cytochrome P450 3A4, 2A6 and 2C9 are involved in the metabolism of montelukast.
Danish: In vitro-undersøgelser med humane levermikrosomer indikerer, at cytokrom P450 3A4, 2A6 og 2C9 er involverede i metaboliseringen af montelukast.
English: Clinical Efficacy: Exercise-induced asthma
Danish: Klinisk effekt: anstrengelsesudløst astma
English: Efficacy of montelukast is supported in paediatric patients 6 months to 2 years of age by extrapolation from the demonstrated efficacy in patients 2 years of age and older with asthma, and is based on similar pharmacokinetic data, as well as the assumption that the disease course, pathophysiology and the medicinal products's effect are substantially similar among these populations.
Danish: Montelukasts effekt hos pædiatriske patienter fra 6 måneder til 2 år understøttes af extrapolering ud fra den påviste effekt hos patienter fra 2 år og ældre med astma og er baseret på lignende farmakokinetiske data såvel som den antagelse, at sygdomsforløbet, patofysiologien og lægemidlets effekt hovedsageligt er ens i disse populationer.
English: With prolonged treatment in clinical trials with a limited number of patients for up to 2 years for adults, and up to 12 months for paediatric patients 6 to 14 years of age, the safety profile did not change.
Danish: I kliniske undersøgelser med forlænget behandling hos et begrænset antal patienter i op til 2 år for voksne og op til 12 måneder for børn i alderen 6-14 år ændrede sikkerhedsprofilen sig ikke.
English: Blisters (unit doses), in packages of: 49, 50 and 56 tablets.
Danish: Blister (unit doser) i pakker med 49, 50 og 56 tabletter.
English: In clinical studies, montelukast inhibits bronchoconstriction due to inhaled LTD4 at doses as low as 5 mg. Bronchodilation was observed within 2 hours of oral administration.
Danish: I kliniske undersøgelser hæmmer montelukast bronkokonstriktion på grund af inhalation af LTD4 ved doser helt ned til 5 mg. Bronkodilatation observeredes inden for 2 timer efter oral administration.
English: • is allergic (hypersensitive) to montelukast or any of the other ingredients of SINGULAIR (see
Danish: • Hvis Deres barn er allergisk (overfølsom) over for montelukast eller et af de øvrige indholdsstoffer i SINGULAIR (se 6.