FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical studies with SINGULAIR 4 mg chewable tablets, the most commonly reported side effects (occurring in at least 1 of 100 patients and less than 1 of 10 paediatric patients treated) thought to be related to SINGULAIR were:
Danish: I afprøvninger på patienter med SINGULAIR 4 mg tyggetabletter var de mest almindelige indberettede bivirkninger (som forekommer hos mindst 1 ud af 100 og hos færre end 1 ud af 10 behandlede børn), som man mener, er forbundet med SINGULAIR:
English: In clinical studies with SINGULAIR 4 mg granules, the most commonly reported side effects (occurring in at least 1 of 100 patients and less than 1 of 10 paediatric patients treated) thought to be related to SINGULAIR were:
Danish: I afprøvninger på patienter med SINGULAIR 4 mg granulat var de mest almindelige indberettede bivirkninger (som forekommer hos mindst 1 ud af 100 og hos færre end 1 ud af 10 behandlede børn), som man mener er forbundet med SINGULAIR:
English: • SINGULAIR is used for the treatment of 2 to 5 year old patients who are not adequately controlled on their medication and need additional therapy.
Danish: • SINGULAIR er til behandling af patienter i alderen 2-5 år, der ikke er tilstrækkeligt behandlet med deres nuværende medicin, og som har brug for yderligere behandling.
English: LIST OF EXCIPIENTS Contains aspartame (E 951).
Danish: Indeholder aspartam (E951).
English: Store in the original package in order to protect from light and moisture.
Danish: Opbevares i original emballage for at beskytte mod lys og fugt.
English: Do not give SINGULAIR to your child if he/she
Danish: Giv ikke SINGULAIR til Deres barn
English: SINGULAIR granules can be taken without regard to the timing of food intake.
Danish: SINGULAIR granulat kan tages uden hensyn til tidspunkt for indtagelse af mad.
English: Subsequently, Section 4.4 of Singulair 4mg OG SPC was revised to include the following wording:
Danish: Efterfølgende blev afsnit 4.4 i produktresuméet for Singulair 4 mg oralt granulat revideret og fik følgende ordlyd:
English: Ask your pharmacist how to dispose of medicines no longer required.
Danish: • Spørg på apoteket hvordan De skal aflevere medicinrester.
English: SPC Harmonisation
Danish: Harmonisering af produktresuméet
English: • Do not use this medicine after the date shown by the six numbers following EXP on the blister.
Danish: • Brug ikke SINGULAIR efter den udløbsdato, der står på pakningen.
English: • allergic reactions including rash, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing, itching, and hives;
Danish: • Allergiske reaktioner med udslæt, hævelse af ansigt, læber, tunge og /eller svælg, som kan forårsage vejrtræknings- eller synkebesvær; kløe og nældefeber
English: 4 mg granules in 175 paediatric patients 6 months to 2 years of age.
Danish: • 4 mg granulat hos 175 pædiatriske patienter i alderen 6 måneder-2 år.
English: The SINGULAIR 4 mg granules formulation is not recommended below 6 months of age.
Danish: SINGULAIR 4 mg granulatformuleringen bør ikke gives til børn under 6 måneder.
English: Patients should seek their doctors' advice as soon as possible if they need more inhalations of short-acting β-agonists than usual.
Danish: Hvis patienten har behov for mere korttidsvirkende inhalations-β-agonist end sædvanlig, bør patienten søge rådgivning hos egen læge så hurtigt som muligt.
English: 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).
Danish: Reduktion i anstrengelsesudløst bronkokonstriktion blev også vist i en korttidsundersøgelse hos børn i alderen 6-14 år (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).
English: 4 mg Granules
Danish: 4 mg Granulat
English: 4 mg chewable tablets in 851 paediatric patients 2 to 5 years of age, and
Danish: • 4 mg tyggetabletter hos 851 pædiatriske patienter i alderen 2-5 år og
English: • rifampicin (used to treat tuberculosis and some other infections) Taking SINGULAIR with food and drink
Danish: • rifampicin (mod tuberkulose og andre infektioner)
English: Symptoms of asthma include: Coughing, wheezing, and chest tightness.
Danish: Symptomer på astma er: Hoste, hvæsende vejrtrækning og trykken for brystet.
English: Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, the United Kingdom
Danish: Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, Storbritannien
English: SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from light and moisture.
Danish: 6.4 Særlige opbevaringsforhold Opbevares i original emballage for at beskytte mod lys og fugt.
English: You should check with your child's doctor or pharmacist if you are not sure.
Danish: Spørg barnets læge eller apoteket, hvis der er noget, De er i tvivl om eller føler Dem usikker på.
English: Merck Sharp & Dohme B.V., Postbox 581, Waarderweg 39, NL-2031 BN, Haarlem, The Netherlands
Danish: Merck Sharp & Dohme B.V., Postbox 581, Waarderweg 39, NL-2031 BN, Haarlem, Holland
English: The CHMP agreed with the following proposed indication for 4mg oral granules:
Danish: CHMP indvilligede i følgende foreslåede indikation for 4 mg oralt granulat:
English: • difficulty breathing because of narrowed airways.
Danish: • Forsnævring af luftvejene som gør vejrtrækningen besværlig.
English: It is important for your child to continue taking SINGULAIR for as long as your doctor prescribes.
Danish: Det er vigtigt, at barnet fortsætter med at tage SINGULAIR, så længe lægen foreskriver det for at bevare kontrollen med astmaen.
English: Therefore, the CHMP agreed with the following proposed indication for 4mg chewable tablets:
Danish: Derfor indvilligede CHMP i følgende foreslåede indikation for 4 mg tyggetabletter:
English: Merck Sharp & Dohme B.V., Postbox 581, Waarderweg 39, NL-2031 BN, Haarlem The Netherlands
Danish: Merck Sharp & Dohme B.V., Postbox 581, Waarderweg 39, NL-2031 BN, Haarlem Holland
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING SINGULAIR 4 mg Tablets - Outer Carton
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE SINGULAIR 4 mg tabletter - Ydre karton
English: For the 5 mg chewable tablet, the Cmax is achieved in 2 hours after administration in adults in the fasted state.
Danish: Med 5 mg tyggetabletten nås Cmax 2 timer efter administration hos fastende voksne.
English: INFORMATION IN BRAILLE SINGULAIR 4 mg
Danish: INFORMATION I BRAILLE-SKRIFT SINGULAIR 4 mg
English: Singulair 4 mg chewable tablets is available in all current EU member states (and in IS and NO) except in FR since the approval given in Mutual Recognition Procedure in 2000.
Danish: Singulair 4 mg tyggetabletter har siden godkendelsen via proceduren for gensidig anerkendelse i 2000 været på markedet i alle de nuværende EU-lande (og i Island og Norge) bortset fra Frankrig.
English: Packaged in polyethylene/aluminum/polyester sachet in:
Danish: 6.5 Emballagetype og pakningsstørrelser Pakket i brev af polyethylen/aluminium/polyester i:
English: If an attack occurs, follow the instructions your doctor has given you for your child.
Danish: Patienter, der får et astmaanfald, skal følge den instruktion lægen har givet.
English: You must tell your doctor right away if your child gets one or more of these symptoms.
Danish: Selvom det ikke påvist, at montelukast forårsager denne tilstand, skal De straks fortælle det til lægen, hvis De eller Deres barn får et eller flere af disse symptomer.
English: The following revision to Section 4.2 of Singulair 4 mg OG SPC was finally accepted:
Danish: Følgende revision af afsnit 4.2 i produktresuméet for Singulair 4 mg oralt granulat blev endelig godkendt.
English: Asthma is a long-term disease.
Danish: Astma er en kronisk lungesygdom.
English: The following wording was therefore accepted for Section 4.2, 4 mg CT and 4 mg OG:
Danish: Følgende ordlyd blev derfor godkendt til afsnit 4.2: 4 mg tyggetablet og 4 mg oralt granulat:
English: Musculoskeletal and connective tissue disorders: arthralgia, myalgia including muscle cramps.
Danish: Knogler, led, muskler og bindevæv: Artralgi, myalgi inklusive muskelkramper.
English: 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).
Danish: 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).
English: General disorders and administration site conditions: asthenia/fatigue, malaise, oedema.
Danish: Almene symptomer og reaktioner på administrationsstedet: Asteni/træthed, utilpashed, ødem.
English: Nervous system disorders: dizziness drowsiness, paraesthesia/hypoesthesia, seizure.
Danish: Nervesystemet: Svimmelhed, døsighed, paræstesi/hypæstesi, kramper.
English: General disorders and administration site conditions thirst
Danish: Almene symptomer og reaktioner på administrationsstedet
English: • feeling unwell, joint or muscle pain, muscle cramps, dry mouth, nausea, vomiting, indigestion, diarrhoea, hepatitis;
Danish: • Utilpashed, led- eller muskelsmerter, muskelkramper, tør mund, kvalme, opkastning, fordøjelsesbesvær, diarré, leverbetændelse.
English: SINGULAIR can treat your child's asthma only if he/she continues taking it.
Danish: Hvis Deres barn holder op med at tage SINGULAIR SINGULAIR kan kun behandle Deres barns astma, hvis barnet fortsætter med at tage det.
English: • scaly and itchy skin
Danish: • Skællet og kløende hud
English: SINGULAIR as prophylaxis of asthma for 2 to 5 year old patients in whom the predominant component is exercise-induced bronchoconstriction.
Danish: SINGULAIR som profylakse til astma til patienter i alderen 2 til 5 år, hvor den fremherskende komponent er anstrengelsesudløst bronkokonstriktion.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION SINGULAIR 4 mg granules montelukast
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) SINGULAIR 4 mg granulat montelukast ANVENDELSESMÅDE Oral anvendelse.
English: Patients should be evaluated after 2 to 4 weeks for response to montelukast.
Danish: Patienterne bør evalueres efter 2 til 4 uger for respons på montelukast.
English: 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).
Danish: 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.
English: Montelukast also decreased "as-needed" β-agonist use and corticosteroid rescue for worsening asthma compared with placebo.
Danish: brug af β-agonist og akut kortikosteroidbehandling til forværret astma i forhold til placebo.
English: Patients should be evaluated after 2 to 4 weeks of treatment with montelukast.
Danish: Patienterne bør evalueres efter 2 til 4 ugers behandling med montelukast.
English: The PDCO, basing its decision on the GINA paediatric handbook 2006 and expert intervention, concluded that, due to a shortage of clinical data in patients aged 6 months - 2 years with asthma, pharmacokinetic data from patients aged 2-5 years diagnosed with asthma cannot be extrapolated to younger patients aged 6 months- 2 years presenting with the same symptoms.
Danish: manglen på kliniske data om patienter i alderen 6 måneder til 2 år med astma ikke kan ekstrapoleres farmakokinetiske data fra patienter i alderen 2-5 år med diagnosen astma til yngre patienter i alderen 6 måneder til 2 år med de samme symptomer.
English: Therefore, the CHMP agreed with the following proposed indication for 4mg chewable tablets and 4mg oral granules:
Danish: Derfor indvilligede CHMP i følgende foreslåede indikation for 4 mg tyggetabletter og 4 mg oralt granulat:
English: Each tablet contains montelukast sodium which corresponds to 4 mg of montelukast.
Danish: Hver tablet indeholder montelukastnatrium, som svarer til 4 mg montelukast.
English: 4 mg granules are available for paediatric patients 6 months to 5 years of age.
Danish: Der fås 4 mg granulat til børn i alderen 6 måneder til 5 år.
English: Gastrointestinal disorders abdominal pain abdominal pain
Danish: Mave-tarmkanalen Abdominalsmerter
English: The first two numbers indicate the month; the last four numbers indicate the year.
Danish: Udløbsdatoen er den sidste dag i den nævnte måned.
English: DATE OF first AUTHORIZATION/RENEWAL OF the AUTHORIZATION [TO BE COMPLETED NATIONALLY]
Danish: DATO FOR FØRSTE MAKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: There have been reports of acute overdose in post-marketing experience and clinical studies with montelukast.
Danish: Der har efter markedsføring og i kliniske undersøgelser, været rapporter om akut overdosering.
English: Gastrointestinal disorders: diarrhoea, dry mouth, dyspepsia, nausea, vomiting.
Danish: Mave-tarmkanalen: Diarré, mundtørhed, dyspepsi, kvalme, opkastning.
English: Singulair is also indicated in the prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction.
Danish: Singulair er også indiceret til astmaprofylakse, hvor den fremherskende komponent er anstrengelsesudløst bronkokonstriktion.
English: HOW TO STORE SINGULAIR
Danish: SÅDAN OPBEVARER DE SINGULAIR
English: Red ferric oxide (E 172)
Danish: Hydroxypropylcellulose (E463) Rød jernoxid (E172)
English: SINGULAIR granules can be administered without regard to the timing of food ingestion.
Danish: SINGULAIR granulat kan administreres uden hensyn til tidspunktet for fødeindtag.
English: If you forget to give SINGULAIR to your child
Danish: Hvis De har glemt at give SINGULAIR til Deres barn Giv SINGULAIR, som lægen har foreskrevet.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING SINGULAIR 4 mg Granules- Outer Carton
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE SINGULAIR 4 mg granulat - Ydre karton
English: The following adverse reactions have been reported in post-marketing use: Blood and lymphatic system disorders: increased bleeding tendency.
Danish: Blod og lymfesystem: Øget blødningstendens.
English: NAME OF THE MARKETING AUTHORISATION HOLDER [To be completed nationally]
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN [Udfyldes nationalt]
English: Merck Sharp & Dohme B.V. Chaussée de Waterloo 1135 B- 1180 Brussels Belgium
Danish: Chaussée de Waterloo 1135 B- 1180 Brussel Belgien
English: 5 mg chewable tablets in approximately 1750 paediatric patients 6 to 14 years of age
Danish: • 5 mg tyggetabletter hos ca. 1750 pædiatriske astmapatienter i alderen 6-14 år, og
English: • SINGULAIR granules can be given either: o directly in the mouth; o OR mixed with a spoonful of cold or room temperature soft food (for example, applesauce, ice cream, carrots and rice).
Danish: • ELLER blandet med en skefuld koldt eller tempereret, blødt mad (f.eks. æblemos, is, gulerødder og ris).
English: • If your child is on anti-asthma medicines, be aware that if the he/she develops a combination of symptoms such as flu-like illness, pins and needles or numbness of arms or legs, worsening of pulmonary symptoms, and/or rash, you should consult your doctor.
Danish: • Hvis Deres barn er i behandling med astmamedicin, bør De kontakte lægen, hvis barnet udvikler en kombination af influenzalignende symptomer, stikkende og prikkende eller sovende fornemmelser i arme eller ben og/eller udslæt.
English: The dosage for paediatric patients 6 months to 5 years of age is one sachet of 4 mg granules daily to be taken in the evening.
Danish: Dosering til børn i alderen 6 måneder-5 år er et brev à 4 mg granulat dagligt om aftenen.
English: MARKETING AUTHORIZATION NUMBER [TO BE COMPLETED NATIONALLY]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) [Udfyldes nationalt]
English: Singulair 4 mg granulado 4 mg Granules
Danish: Singulair 4 mg granulado 4 mg Granulat
English: Patients should be evaluated after 2 to 4 weeks for response to montelukast treatment.
Danish: Patienterne bør vurderes efter 2-4 uger for respons på montelukastbehandlingen.
English: For children 6 to 14 years old, SINGULAIR 5 mg chewable tablets are available.
Danish: Til børn i alderen 6-14 år fås SINGULAIR 5 mg tyggetabletter.
English: The dosage for paediatric patients 2-5 years of age is one 4 mg chewable tablet daily to be taken in the evening.
Danish: Dosering til børn i alderen 2-5 år er en tyggetablet à 4 mg dagligt om aftenen.
English: NAME OF THE MEDICINAL PRODUCT SINGULAIR 4 mg granules
Danish: LÆGEMIDLETS NAVN SINGULAIR 4 mg granulat.
English: Hepatobiliary disorders: elevated levels of serum transaminases (ALT, AST), cholestatic hepatitis.
Danish: Lever og galdeveje: Forhøjet ALAT og ASAT, cholestatisk hepatitis.
English: For children 2 to 5 years old, SINGULAIR 4 mg chewable tablets and SINGULAIR 4 mg granules are available.
Danish: Til børn i alderen 2-5 år fås SINGULAIR 4 mg tyggetabletter og SINGULAIR 4 mg granulat.
English: For children 2 to 5 years old, SINGULAIR 4 mg chewable tablets and 4 mg granules are available.
Danish: Til børn i alderen 2-5 år fås SINGULAIR 4 mg tyggetabletter og 4 mg granulat.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION ONE CHEWABLE TABLET CONTAINS MONTELUKAST SODIUM, WHICH IS EQUIVALENT TO 4 MG MONTELUKAST.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En tyggetablet indeholder montelukastnatrium svarende til 4 mg montelukast.
English: INFORMATION IN BRAILLE SINGULAIR 4 mg granules
Danish: INFORMATION I BRAILLE-SKRIFT SINGULAIR 4 mg granulat
English: • abdominal pain
Danish: Abdominalsmerter
English: 5 mg chewable tablets are available for paediatric patients 6 to 14 years of age.
Danish: Der fås 5 mg tyggetabletter til børn fra 6-14 år.
English: Merck Sharp & Dohme Ltd ; Hertford Road, Hoddesdon, Hertfordshire EN119BU United Kingdom
Danish: Merck Sharp & Dohme Ltd ; Hertford Road, Hoddesdon, Hertfordshire EN119BU Storbritannien
English: • swelling (inflammation) in the lining of the airways.
Danish: • Betændelse i luftvejene; det vil sige, der opstår hævelse af luftvejene.
English: Merck Sharp & Dohme Ltd ; Hertford Road, Hoddesdon, Hertfordshire EN119BU, United Kingdom
Danish: Merck Sharp & Dohme Ltd ; Hertford Road, Hoddesdon, Hertfordshire EN119BU, Storbritannien
English: This subsection is not applicable for the SINGULAIR 4 mg chewable tablets since they are intended for use in children 2 to 5 years of age, however the following information is relevant to the active ingredient, montelukast.
Danish: Dette afsnit er ikke relevant for SINGULAIR 4 mg tyggetabletter, da disse er beregnet til brug hos børn fra 2-5 år.
English: There were no side effects reported in the majority of overdose reports.
Danish: I de fleste tilfælde med overdosering er der ikke indberettet bivirkninger.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One sachet of granules contains montelukast sodium, which is equivalent to 4 mg montelukast.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Et brev granulat indeholder montelukastnatrium svarende til 4 mg montelukast.
English: Paediatric Patients 6 months up to 2 years old (one 6-week study; n=175)
Danish: - 2 år (Én 6-ugers under-søgelse; n=175)
English: Singulair mini 4 mg Granulat4 mg Granules
Danish: Singulair mini 4 mg Granulat4 mg Granulat
English: Hyprolose (E 463)
Danish: Hydroxypropylcellulose (E463)
English: • SINGULAIR may also be used as an alternative treatment to inhaled corticosteroids for 2 to 5 year old patients who have not recently taken oral corticosteroids for their asthma and have shown that they are unable to use inhaled corticosteroids.
Danish: • SINGULAIR kan også anvendes som behandling i stedet for kortikosteroider som inhalation til patienter i alderen 2-5 år, som ikke for nylig har taget kortikosteroidtabletter mod deres astma, og som har vist, at de ikke er i stand til at anvende kortikosteroider som inhalation.
English: This subsection is not applicable for the SINGULAIR 4 mg granules since they are intended for use in children 6 months to 5 years of age, however the following information is relevant to the active ingredient, montelukast.
Danish: Dette afsnit er ikke relevant for SINGULAIR 4 mg granulat, da dette er beregnet til brug hos børn fra 6 måneder til 5 år.
English: 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).
Danish: Brug af montelukast som alternativ behandlingsmulighed til lavdosis inhalationskortiko-steroid til børn med mild vedvarende astma bør kun tages i betragtning til patienter, som ikke for nylig har haft alvorlig astmaanfald i anamnesen, hvor oral anvendelse af kortikosteroid var påkrævet, og som har vist, at de ikke er i stand til at anvende inhalationskortikosteroider (se pkt.
English: • SINGULAIR is also indicated in the prophylaxis of asthma from 2 years of age and older in which the predominant component is exercise-induced bronchoconstriction.
Danish: • SINGULAIR er også indiceret til astmaprofylakse fra 2-års-alderen og derover, hvor den fremherskende komponent er anstrengelsesudløst bronkokonstriktion.
English: For children 6 months to 2 years old, SINGULAIR 4 mg granules are available.
Danish: Til børn i alderen 6 måneder til 5 år fås SINGULAIR 4 mg granulat.
English: • Medicines should not be disposed of via wastewater or household waste.
Danish: Af hensyn til miljøet må De ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One sachet of granules contains montelukast sodium, which is equivalent to 4 mg montelukast.
Danish: ANGIVELSE AF AKTIVT STOF Et brev granulat indeholder montelukastnatrium svarende til 4 mg montelukast.
English: Characteristics in Patients.
Danish: Pædiatriske patienter
English: The SINGULAIR 4 mg chewable tablet is not recommended below 2 years of age.
Danish: SINGULAIR 4 mg tyggetabletten bør ikke gives til børn under 2 år.
English: “Singulair is also indicated in the prophylaxis of asthma from 2 years of age and older in which the predominant component is exercise-induced bronchoconstriction”.
Danish: "Singulair er også indiceret til astmaprofylakse fra 2-års-alderen og derover, hvor den fremherskende komponent er anstrengelsesudløst bronkokonstriktion".
English: SINGULAIR PAEDIATRIC4 mg Chewable tablets Oral use
Danish: SINGULAIR PAEDIATRIC4 mg Tyggetabletter Oral anvendelse4 mg
English: Singulair may also be an alternative treatment option to low-dose inhaled corticosteroids for patients (4 mg OG, CT: 2 to 5 year old) with mild persistent asthma 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.
Danish: Singulair er muligvis også et alternativ til behandling med lavdosis inhalerede kortikosteroider af patienter (4 mg oralt granulat, tyggetabletter: i alderen 2 til 5 år) med mild persisterende astma, som ikke for nylig har haft alvorlige astmaanfald, hvor oral kortikosteroidanvendelse var påkrævet, og som har vist, at de ikke er i stand til at anvende inhalerede kortikosteroider.
English: Use during pregnancy
Danish: Graviditet
English: Clinical Efficacy: Add-on use
Danish: Klinisk effekt: anvendelse som tillægsbehandling