natgillin/translations-raw huggingface dataset:
FEV1 øgedes fra 1,83 L til 2,09 L i montelukastgruppen og fra 1,85 L til 2,14 L i fluticasongruppen.
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.
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).
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).
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.
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.
Middeløgningen fra baseline i % forudsagde, at FEV1 var 0,6% i montelukastbehandlingsgruppen og 2,7% i fluticasonbehandlingsgruppen.
The mean increase from baseline in % predicted FEV1 was 0.6% in the montelukast treatment group, and 2.7% in the fluticasone treatment group.
Hos aber opstod bivirkninger ved doser fra 150 mg/kg/dag (>232 gange den systemiske påvirkning set ved klinisk dosis).
In monkeys, the adverse effects appeared at doses from 150 mg/kg/day (>232-fold the systemic exposure seen at the clinical dose).
• phenytoin (mod epilepsi)
• phenytoin (used for treatment of epilepsy)
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).
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.
Behandling med montelukast hæmmer både den tidlige og den sene fase af bronkokonstriktionen ved antigen belastning.
Treatment with montelukast inhibited both early- and late-phase bronchoconstriction due to antigen challenge.
Til børn fra 2 til 5 år.
For children 2 to 5 years of age
Medlemsstat Indehaver af markedsføringstiladelse
Member State Marketing Authorisation Holder
Merck Sherp & Dohme Chaussée de Waterloo 1135 B-1180 Brussel Belgien
Merck Sherp & Dohme Chaussée de Waterloo 1135 B-1180 Brussels Belgium
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.
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.
• Øvrige indholdsstoffer: Mannitol, hydroxypropylcellulose (E463), og magnesiumstearat.
• The other ingredients are: Mannitol, hyprolose (E 463), and magnesium stearate.
• Deres barn skal også tage tabletten, selvom barnet ikke har symptomer eller hvis han/hun har et akut astmaanfald.
• It should be taken even when your child has no symptoms or if he/she has an acute asthma attack.
Man ved ikke, om SINGULAIR udskilles i modermælk.
It is not known if SINGULAIR appears in breast milk.
Klinisk effekt: monoterapi af astma
Clinical Efficacy: Monotherapy of asthma
Der sås lille fald i afkommets kropsvægt i fertilitetsundersøgelse med hunrotter ved 200 mg/kg/dag (>69 gange klinisk, systemisk påvirkning).
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).
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).
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).
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.
Montelukast (5 mg once daily) was shown to exert an anti-asthmatic effect that was larger than the effect obtained with placebo.
De hyppigst observerede hændelse var konsistente ned sikkerhedsprofilen for montelukast og inkluderede abdominalsmerter, somnolens, tørst, hovedpine, opkastning og psykomotorisk hyperaktivitet.
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.
- Formålet med indbringelsen af sagen var at harmonisere produktresuméerne, etiketteringen, indlægssedlen og afsnit 3.
- the scope of the referral was the harmonisation of the Summaries of Products Characteristics, labelling, package leaflet and Module 3.
Denne forsnævring kan ændres som reaktion på forskellige forhold.
This narrowing of airways worsens and improves in response to various conditions.
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.
Bulgaria, Cyprus, Estonia, Finland, Germany, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta, Norway, Portugal, Romania, Slovenia, Spain, Sweden, United Kingdom: SINGULAIR
- CHMP konkluderede, at markedsføringstilladelsen kunne harmoniseres for Singulair 4 mg tyggetabletter til patienter i alderen 2 til 5 år til følgende indikationer:
- 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:
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).
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).
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.
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.
Er De i tvivl så spørg barnets læge eller apoteket.
If you have any further questions on the use of this product, ask your child's doctor or pharmacist.
Patienter der fik montelukast havde flere dage uden astma end de patienter, der fik placebo.
Patients receiving montelukast had more days without asthma than those receiving placebo.
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).
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).
Montelukast frarådes som monoterapi til patienter med moderat vedvarende astma.
Montelukast is not recommended as monotherapy in patients with moderate persistent asthma.
SINGULAIR indeholder aspartam, som er en phenylalaninkilde.
SINGULAIR contains aspartame, a source of phenylalanine.
I meget sjældne tilfælde er der rapporteret Churg-Strauss Syndrom (CSS) hos astmapatienter i behandling med montelukast (se pkt.
Very rare cases of Churg-Strauss Syndrome (CSS) have been reported during montelukast treatment in asthmatic patients (see section 4.4).
ATC-kode: R03D C03
Pharmacotherapeutic group: Leukotriene receptor antagonist ATC-code: R03D C03
• SINGULAIR-tabletter er ikke beregnet til behandling af akutte astmaanfald.
• Oral SINGULAIR is not meant to treat acute asthma attacks.
Montelukast er vist at passere placentabarrieren og udskilles i modermælken hos dyr.
Montelukast has been shown to cross the placental barrier and is excreted in breast milk of animals.
Dataene vedrørende virkning fra kliniske undersøgelser af pædiatriske patienter i alderen 6 måneder til 2 år med persistent astma er begrænsede.
Efficacy data from clinical trials in paediatric patients 6 months to 2 years of age with persistent asthma are limited.
• Deres barn bør ikke tage acetylsalicylsyre (aspirin), hvis astmaen bliver værre af aspirin eller anden nonsteroid anti-inflammatorisk medicin (visse former for smertestillende medicin).
• 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.
- 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:
- 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:
• SINGULAIR granulat er ikke beregnet til at blive opløst i væske.
• SINGULAIR granules are not intended to be dissolved in liquid.
Samtidig blev det af indehaveren af markedsføringstilladelsen ajourførte afsnit 3 opdateret til CTD-format (Comparative Toxicogenomics Database) i denne procedure for indbragte sager.
Simultaneously, the MAH updated module 3 was updated to CTD format in this referral procedure.
• Fortæl det straks til lægen, hvis Deres barns astma eller vejrtrækning bliver værre.
• If your child's asthma or breathing gets worse, tell your doctor immediately.
Vær ekstra forsigtig med at tage SINGULAIR
Take special care with SINGULAIR
Der fås 4 mg tyggetabletter som alternativ formulering til patienter fra 2-5 år.
4 mg chewable tablets are available as an alternative formulation for paediatric patients 2 to 5 years of age.
I dyreforsøg påvirkede montelukast ikke fertilitet eller reproduktionsevne ved systemisk påvirkning >24 gange højere end klinisk systemisk påvirkning.
In animal studies, montelukast did not affect fertility or reproductive performance at systemic exposure exceeding the clinical systemic exposure by greater than 24-fold.
SINGULAIR tyggetabletter indeholder aspartam, en phenylalaninkilde.
SINGULAIR chewable tablets contain aspartame, a source of phenylalanine.
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
What SINGULAIR is and what it is used for Before SINGULAIR is taken How to take SINGULAIR Possible side effects
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.
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.
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.
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.
[Udfyldes nationalt]
[TO BE COMPLETED NATIONALLY]
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:
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:
Denne indlægsseddel blev senest godkendt {MM/ÅÅÅÅ }
This leaflet was last approved in {DD.MM.YYYY.}
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.
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.
Hvis Deres barn har taget for meget SINGULAIR Kontakt straks barnets læge for at få rådgivning.
If your child takes more SINGULAIR than he/she should Contact your child's doctor immediately for advice.
SINGULAIR granulat er ikke beregnet til at blive opløst i væske før administration.
SINGULAIR granules are not intended to be dissolved in liquid for administration.
Montelukast kan administreres samtidig med anden profylaktisk og kronisk behandling af astma.
Montelukast may be administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma.
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 7, 10, 14, 20, 28, 30, 49, 50, 56, 98, 100, 140, 200 tyggetabletter
PHARMACEUTICAL FORM AND CONTENTS 7, 10, 14, 20, 28, 30, 49, 50, 56, 98, 100, 140, 200 chewable tablets.
Justering af dosis er ikke nødvendig hos patienter med nyreinsufficiens eller mildt til moderat nedsat leverfunktion.
No dosage adjustment is necessary for patients with renal insufficiency, or mild to moderate hepatic impairment.
MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS SINGULAIR 4 mg tabletter - Blister
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS SINGULAIR 4 mg tablets - Blister
Hjerte: Palpitationer.
Cardiac disorders: palpitations.
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.
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.
Efter administration af 4 mg tyggetablet til fastende, pædiatriske patienter i alderen 2-5 år, nås Cmax efter 2 timer.
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.
• 10 mg filmovertrukne tabletter hos ca. 4000 voksne astmapatienter i alderen 15 år og opefter
10 mg film-coated tablets in approximately 4000 adult patients 15 years of age and older
Hvis Deres barn har taget for meget SINGULAIR
If your child stops taking SINGULAIR
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).
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.
• 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.
• 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;
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.
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.
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.
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.
Hud og subkutane væv: Angioødem, blå mærker, urticaria, pruritus, udslæt, erythema nodosum.
Skin and subcutaneous tissue disorders: angiooedema, bruising, urticaria, pruritus, rash, erythema nodosum.
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.
The SPCs proposed by the MAH were those approved through the MRP in the "old" member states and in CY and IS.
Der fås 10 mg filmovertrukne tabletter til voksne fra 15 år og opefter.
10 mg film-coated tablets are available for adults 15 years of age and older.
Dyreundersøgelser med rotter har vist, at montelukast udskilles i dyrenes modermælk (se pkt.
Studies in rats have shown that montelukast is excreted in milk (see section 5.3).
Blister i pakker med 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140 og 200 tabletter.
Blisters in packages of: 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140 and 200 tablets.
Forskellen mellem grupperne i LS-middeløgning var signifikant: 7,3% med 95% konfidensinterval på 2,9; 11,7.
The between group difference in LS means was significant: 7.3% with a 95%CI of 2.9; 11.7.
Fortæl det altid til lægen eller apoteket, hvis Deres barn bruger anden medicin eller har brugt det for nylig.
Please tell your doctor or pharmacist if your child is taking or has recently taken other medicines, including those obtained without a prescription.
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%).
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%).
Derudover er følgende bivirkninger set i kliniske undersøgelser med SINGULAIR 10 mg filmovertrukne tabletter og 5 mg eller 4 mg tyggetabletter:
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:
Hos patienter i alderen 2 til 5 år er anstrengelsesudløst bronkokonstriktion muligvis den fremherskende manifestation af vedvarende astma, der kræver behandling med inhalerede kortikosteroider.
In 2 to 5 year old patients, exercise-induced bronchoconstriction may be the predominant manifestation of persistent asthma that requires treatment with inhaled corticosteroids.
Indehaveren af markedsføringstilladelsen fremlagde et harmoniseret afsnit 3 i CTD-format for Singulair 4 mg granulat og 4 mg tyggetabletter.
The MAH provided harmonised modules 3 in CTD format for Singulair 4 mg granules and 4 mg chewable tablets.
Den gennemsnitlige peak plasmakoncentration (Cmax) opnås, for den 10 mg filmovertrukne tablet, 3 timer (Tmax) efter administration hos fastende voksne.
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.
Derfor er den endelige reviderede indikation for 4 mg tyggetabletter og 4 mg oralt granulat som følger:
Therefore the final revised indication for 4mg CT and 4mg OG is as follows:
Pakninger à 7, 20, 28 og 30 breve.
Cartons of 7, 20, 28 and 30 sachets.
• Øget blødningstendens, blå mærker, knuderosen (ømme, røde knuder under huden oftest på skinnebenene), hjertebanken.
• increased bleeding tendency, bruising, tender red lumps under the skin most commonly on your shins (erythema nodosum), palpitations;
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).
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).
Forskellen mellem grupperne i LS-middeløgning i FEV1 var 0,02 L med 95% konfidensinterval på0,06, 0,02.
The between-group difference in LS mean increase in FEV1 was -0.02 L with a 95% CI of -0.06, 0.02.
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%).
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%).