natgillin/translations-raw huggingface dataset:
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.
Svimmelhed, døsighed, paræstesi/ hypæstesi, kramper.
Nervous system disorders: dizziness drowsiness, paraesthesia/ hypoesthesia, seizure.
Palpitationer.
Cardiac disorders: palpitations.
Diarré, mundtørhed, dyspepsi, kvalme, opkastning.
Gastrointestinal disorders: diarrhoea, dry mouth, dyspepsia, nausea, vomiting.
Hud og subkutane væv:
Hepatobiliary disorders: elevated levels of serum transaminases (ALT, AST), cholestatic hepatitis.
Angioødem, blå mærker, urticaria, pruritus, udslæt, erythema nodosum.
Skin and subcutaneous tissue disorders: angiooedema, bruising, urticaria, pruritus, rash, erythema nodosum.
Artralgi, myalgi inklusive muskelkramper.
Musculoskeletal and connective tissue disorders: arthralgia, myalgia including muscle cramps.
Asteni/ træthed, utilpashed, ødem.
General disorders and administration site conditions: asthenia/ fatigue, malaise, oedema.
4. 4).
Very rare cases of Churg-Strauss Syndrome (CSS) have been reported during montelukast treatment in asthmatic patients (see section 4.4).
1 uge, uden klinisk signifikante hændelser.
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.
61 mg/ kg for et 42 måneder gammelt barn).
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).
Det vides ikke, om montelukast kan dialyseres ved peritoneal - eller hæmodialyse.
It is not known whether montelukast is dialyzable by peritoneal- or hemo-dialysis.
ATC- kode:
Leukotriene receptor antagonist ATC-code:
I kliniske undersøgelser hæmmer montelukast bronkokonstriktion på grund af inhalation af LTD4 ved doser helt ned til 5 mg.
In clinical studies, montelukast inhibits bronchoconstriction due to inhaled LTD4 at doses as low as 5 mg.
Bronkodilatation observeredes inden for 2 timer efter oral administration.
Bronchodilation was observed within 2 hours of oral administration.
Den bronkodilaterende virkning af en β- agonist var additiv til den fremkaldt af montelukast.
The bronchodilation effect caused by a β -agonist was additive to that caused by montelukast.
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.
In adult and paediatric patients 2 to 14 years of age, montelukast, compared with placebo, decreased peripheral blood eosinophils while improving clinical asthma control.
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).
22 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).
Forbedring i patientrapporteret dag - og natastmasymptom- score var signifikant bedre end med placebo.
Improvement in patient-reported daytime and nighttime asthma symptoms scores was significantly better than placebo.
21 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:
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% versus 1, 04%; brug af β- agonist: - 8, 70% versus 2, 64%).
5.43% vs 1.04%; β -agonist use: -8.70% vs 2.64%).
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:
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% versus 13, 3%; brug af β- agonist: - 28, 28% versus - 43, 89%).
7.49% vs 13.3%; β -agonist use: -28.28% vs -43.89%).
42% af patienterne behandlet med montelukast opnåede samme respons).
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).
I en 8- ugers undersøgelse med børn i alderen 6- 14 år, forbedrede montelukast 5 mg, en gang dagligt, respirationsfunktionen signifikant sammenlignet med placebo (FEV1 8, 71% versus 4, 16% ændring fra baseline; morgen PEFR 27, 9 l/ min versus 17, 8 l/ min ændring fra baseline) og nedsatte p. n. brug af β - agonist (- 11, 7% versus +8, 2% ændring fra baseline).
In an 8-week study in paediatric patients 6 to 14 years of age, montelukast 5 mg once daily, compared with placebo, significantly improved respiratory function (FEV1 8.71% vs 4.16% change from baseline; AM PEFR 27.9 L/ min vs 17.8 L/ min change from baseline) and decreased "as-needed" β -agonist use (-11.7% vs +8.2% change from baseline).
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 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.
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.
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.
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.
Forskellen mellem grupperne i LS- middeløgning i FEV1 var 0, 02 L med 95% konfidensinterval på - 0, 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.
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.
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.
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.
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.
Forskellen mellem grupperne i LS- middeløgning for procentdelen af dage med anvendelse af β- agonist var signifikant:
The between group difference in LS means for the percentage of days with β -agonist use was significant:
2, 7 med 95% konfidensinterval på 0, 9, 4, 5.
2.7 with a 95% CI of 0.9, 4.5.
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).
Procentdelen af patienter med systemisk (fortrinsvis oral) anvendelse af kortikosteroid i undersøgelsesperioden var 17, 8% i montelukastgruppen og 10, 5% i fluticasongruppen.
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.
Forskellen mellem grupperne i LS- middeløgning var signifikant:
The between group difference in LS means was significant:
7, 3% med 95% konfidensinterval på 2, 9; 11, 7.
7.3% with a 95%CI of 2.9; 11.7.
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).
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).
Montelukast nedsatte ligeledes 22 p. n. brug af β- agonist og akut kortikosteroidbehandling til forværret astma i forhold til placebo.
Montelukast also decreased "as-needed" β -agonist use and 23 corticosteroid rescue for worsening asthma compared with placebo.
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].
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].
Reduktion af årlig forekomst af periodiske eksacerbationer var 31, 9%, med 95% konfidensinterval på 16, 9, 44, 1.
The percentage reduction in yearly EE rate was 31.9%, with a 95% CI of 16.9, 44.1.
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.
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.
En 12- ugers undersøgelse hos voksne viste signifikant reduktion i anstrengelsesudløst bronkokonstriktion (maksimalt fald i FEV1 22, 33% for montelukast versus 32, 40 for placebo; tid til restitution til inden for 5% af baseline FEV1 44, 22 min versus 60, 64 min).
Significant reduction of exercise-induced bronchoconstriction (EIB) was demonstrated in a 12-week study in adults (maximal fall in FEV1 22.33% for montelukast vs 32.40% for placebo; time to recovery to within 5% of baseline FEV1 44.22 min vs 60.64 min).
Denne effekt var vedvarende gennem hele 12- ugers undersøgelsen.
This effect was consistent throughout the 12- week study period.
Reduktion i anstrengelsesudløst bronkokonstriktion blev også vist i en korttidsundersøgelse hos børn (maksimalt fald i FEV1 18, 27% versus 26, 11%; tid til restitution til inden for 5% af baseline FEV1 17, 76 min versus 27, 98 min).
Reduction in EIB was also demonstrated in a short term study in paediatric patients 6 to 14 years of age (maximal fall in FEV1 18.27% vs 26.11%; time to recovery to within 5% of baseline FEV1 17.76 min vs 27.98 min).
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- agonist - 27, 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).
Absorption:
Absorption.
Den gennemsnitlige peak plasma - koncentration (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.
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.
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).
23 Distribution:
Distribution.
Steady- state- distributionsvolumen af montelukast er 8- 11 liter i gennemsnit.
The steady-state volume of distribution of montelukast averages 8-11 liters.
Biotransformation:
24 Biotransformation.
In vitro- undersøgelser med humane levermikrosomer indikerer, at cytokrom P450 3A4, 2A6 og 2C9 er involverede i metaboliseringen af montelukast.
In vitro studies using human liver microsomes indicate that cytochrome P450 3A4, 2A6 and 2C9 are involved in the metabolism of montelukast.
Baseret på yderligere in vitro- resultater i humane levermikrosomer, hæmmer terapeutiske plasmakoncentrationer af montelukast ikke cytokrom P450 3A4, 2C9, 1A2, 2A6, 2C19 eller 2D6.
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.
Elimination:
Elimination.
Plasmaclearance af montelukast er i gennemsnit 45 ml/ min hos raske voksne.
The plasma clearance of montelukast averages 45 ml/ min in healthy adults.
Efter oral dosis af radioaktivt mærket montelukast blev 86% af radioaktiviteten genvundet i 5 dages fæcesindsamling og < 0, 2% blev genvundet i urinen.
Following an oral dose of radiolabeled montelukast, 86% of the radioactivity was recovered in 5-day fecal collections and < 0.2% was recovered in urine.
Patientkarakteristika:
Characteristics in Patients.
Der er ingen data vedrørende montelukasts farmakokinetik hos patienter med alvorlig leverinsufficiens (Child- Pugh score > 9).
There are no data on the pharmacokinetics of montelukast in patients with severe hepatic insufficiency (Child-Pugh score > 9).
Der er i dyretoksicitetsundersøgelser observeret mindre serum- biokemiske forandringer af kortvarig natur i ALAT, glucose, phosphor og triglycerider.
In animal toxicity studies, minor serum biochemical alterations in ALT, glucose, phosphorus and triglycerides were observed which were transient in nature.
Disse opstod ved doser som gav > 17 gange den systemiske påvirkning opnået ved klinisk dosis.
These occurred at dosages which provided > 17-fold the systemic exposure seen at the clinical dosage.
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).
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.
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 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.
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.
No deaths occurred following a single oral administration of montelukast sodium at doses up to 5,000 mg/ kg in mice and rats (15,000 mg/ m2 and 30,000 mg/ m2 in mice and rats, respectively), the maximum dose tested.
Denne dosis svarer til 25. 000 gange den anbefalede daglige dosis til voksne mennesker (baseret på en voksen patientvægt på 50 kg).
This dose is equivalent to 25,000 times the recommended daily adult human dose (based on an adult patient weight of 50 kg).
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).
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).
Montelukast var hverken mutagent i in vitro - eller in vivo- undersøgelser eller tumorgent hos gnavere.
Montelukast was neither mutagenic in in vitro and in vivo tests nor tumorigenic in rodent species.
24 6.
25 6.
Mannitol Hydroxypropylcellulose (E463) Magnesiumstearat.
Mannitol Hyprolose (E 463) Magnesium stearate
Pakket i brev af polyethylen/ aluminium/ polyester i:
Packaged in polyethylene/ aluminum/ polyester sachet in:
[Udfyldes nationalt]
MARKETING AUTHORIZATION HOLDER [To be completed nationally.]
[Udfyldes nationalt]
[TO BE COMPLETED NATIONALLY.]
DATO FOR FØRSTE MAKEDSFØRINGSTILLADELSE/ FORNYELSE AF TILLADELSEN
DATE OF first AUTHORIZATION/ RENEWAL OF the AUTHORIZATION
SINGULAIR 4 mg tyggetabletter.
SINGULAIR 4 MG CHEWABLE TABLETS
En tyggetablet indeholder montelukastnatrium svarende til 4 mg montelukast.
ONE CHEWABLE TABLET CONTAINS MONTELUKAST SODIUM, WHICH IS EQUIVALENT TO 4 MG MONTELUKAST.
Hjælpestof:
EXCIPIENT:
Aspartam (E951) 1, 2 mg pr. tablet.
ASPARTAME (E 951) 1.2 MG PER TABLET.
6. 1.
FOR A FULL LIST OF EXCIPIENTS, SEE SECTION 6.1.
Tyggetabletter.
CHEWABLE TABLET.
Lyserød, oval, bikonveks, med ” SINGULAIR ” indgraveret på den ene side og ” MSD 711 ” på den anden side.
Pink, oval, bi-convex-shaped, SINGULAIR engraved on one side and MSD 711 on the other.
(“ efter behov ”).
SINGULAIR is indicated in the treatment of asthma as add-on therapy in those 2 to 5 year old patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “ as-needed” short acting β -agonists provide inadequate clinical control of asthma.
Dosering til børn i alderen 2- 5 år er en tyggetablet à 4 mg dagligt om aftenen.
The dosage for paediatric patients 2-5 years of age is one 4 mg chewable tablet daily to be taken in the evening.
SINGULAIR 4 mg tyggetabletten bør ikke gives til børn under 2 år.
The SINGULAIR 4 mg chewable tablet formulation is not recommended below 2 years of age.
26 SINGULAIR som alternativ behandlingsmulighed til lavdosis inhalationskortikosteroid til mild vedvarende astma:
27 SINGULAIR as an alternative treatment option to low-dose inhaled corticosteroids for mild, persistent asthma:
4. 1).
The use of montelukast as an alternative treatment option to low-dose inhaled corticosteroids for children with mild persistent asthma should only be considered for patients who do not have a recent history of serious asthma attacks that required oral corticosteroid use and who have demonstrated that they are not capable of using inhaled corticosteroids (see section 4.1).
Hos 2- 5 årige patienter kan anstrengelsesudløst bronkial konstriktion være den overvejende manifestation ved vedvarende astma.
In 2 to 5 year old patients, exercise-induced bronchoconstriction may be the predominant manifestation of persistent asthma that requires treatment with inhaled corticosteroids.
Denne tilstand behandles ofte med systemiske kortikosteroider.
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 Churg- Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy.
27 SINGULAIR indeholder aspartam, som er en phenylalaninkilde.
28 SINGULAIR contains aspartame, a source of phenylalanine.