FrancophonIA/ELRC3.0 huggingface dataset:
English: Lizipadol 20 mg pastillas para chupar lozenge oromucosal use
Danish: Spain ambroxolhydrochlorid Lizipadol 20 mg pastillas para chupar sugetablet orofaryngeal anvendelse
English: Via Beato Sebastiano Valfre 4, 10121 Torino Italy
Danish: Via Beato Sebastiano Valfre 4, 10121 Torino Italy ambroxolhydrochlorid Ambroxolo Pharmentis 15 mg/2 ml til inhalation
English: Mucosolvan solution for injection intravenous use
Danish: Mucosolvan injektionsvæske, opløsning intravenøs anvendelse
English: Ambroxol Temmler 75mg Retardkapseln prolonged-release capsule, hard
Danish: Germany ambroxolhydrochlorid Ambroxol Temmler 75mg Retardkapseln depotkapsel, hård oral anvendelse
English: BROMHEXIN HELCOR 8 mg 8 mg
Danish: Romania bromhexinhydrochlorid BROMFLUEX 8 mg 8 mg
English: Mucoangin 17,86 mg/ml Spray zur Anwendung in der Mundhöhle oromucosal spray oral use
Danish: Austria ambroxolhydrochlorid Mucoangin 17,86 mg/ml Spray zur
English: Ambro-AbZ 3 mg/ml Lösung zum Einnehmen
Danish: Germany ambroxolhydrochlorid Ambro-AbZ 3 mg/ml Lösung zum
English: Ambroxol 30 Saft - 1A Pharma
Danish: 82041 Oberhaching Germany ambroxolhydrochlorid Ambroxol 30 Saft - 1A Pharma
English: Mucoangin Menthe pastille oropharyngeal use
Danish: Belgium ambroxolhydrochlorid Mucoangin Menthe pastil orofaryngeal anvendelse
English: Ambroxine pastille oropharyngeal use
Danish: Belgium ambroxolhydrochlorid Bisolangin pastil orofaryngeal anvendelse
English: Ambro-ratiopharm 6mg/ml Lösung zum Einnehmen
Danish: Germany ambroxolhydrochlorid Ambro-ratiopharm 6mg/ml Lösung zum
English: IDYL Hoesttabletten Broomhexine HCl 8 mg, tabletten
Danish: 1112 BA DIEMEN The Netherlands bromhexinhydrochlorid IDYL Hoesttabletten Broomhexine HCl 8 mg, tabletten
English: Balsoprim suspensión
Danish: Opløsning til oral anvendelse
English: Ambroxole hydrochloride, clenbuterol
Danish: Austria ambroxolhydrochlorid clenbuterol
English: Flavamed Hustensaft 30 mg/5 ml Lösung zum Einnehmen
Danish: Germany ambroxolhydrochlorid Flavamed Hustensaft 30 mg/5 ml Lösung zum Einnehmen
English: 85033 Episcopia -Potenza Italy
Danish: 85033 Episcopia -Potenza Italy ambroxolhydrochlorid Ambrotus
English: Flavamed 3 mg/ml peroralna raztopina
Danish: Germany ambroxolhydrochlorid Flavamed 3 mg/ml peroralna raztopina
English: BOEHRINGER INGELHEIM INTERNATIONAL GmbHBinger Strasse 173
Danish: Estland BOEHRINGER INGELHEIM INTERNATIONAL GmbHBinger Strasse 173
English: Flavamed 6 mg/ml peroralna raztopina
Danish: Germany ambroxolhydrochlorid Flavamed 6 mg/ml peroralna raztopina
English: 851 01, Bratislava Slovak Republic
Danish: 851 01, Bratislava Slovak Republic ambroxolhydrochlorid MUCOSIN tablety
English: Afxentiou 27, Acropolis Centre, Cyprus
Danish: Acropolis Centre,
English: SIA Briz, Rasas iela 5, Riga, 1057, Latvia bromhexine hydrochloride
Danish: Letland STIROLBIOFARM BALTIKUM SIA, Rasas iela 5, Riga, Latvia ambroxolhydrochlorid Ambroksols Stirol 75 mg prolonged-release tablets
English: Vicks Hoestdrank broomhexinehydrochloride 8 mg/5ml, drank
Danish: 1033 SB AMSTERDAM The Netherlands bromhexinhydrochlorid HEMA Hoestdrank Broomhexine HCl 8 mg/ 5 ml, drank
English: Ambroxol 7,5 TT Temmler Trinktabletten soluble tablet
Danish: Germany ambroxolhydrochlorid Ambroxol 7,5 TT Temmler
English: IDYL Hoestdrank Broomhexine HCl 4 mg/5 ml, drank
Danish: 1112 BA DIEMEN The Netherlands bromhexinhydrochlorid IDYL Hoestdrank Broomhexine HCl 4 mg/5 ml, drank
English: Ambro-ratiopharm 3mg/ml Lösung zum Einnehmen
Danish: Germany ambroxolhydrochlorid Ambro-ratiopharm 3mg/ml Lösung zum
English: Avda Osa Mayor, 4 28023 Aravaca Madrid
Danish: 28023 Aravaca
English: 4879 AC ETTEN LEUR The Netherlands bromhexine hydrochloride
Danish: 4879 AC ETTEN LEUR The Netherlands bromhexinhydrochlorid Broomhexine HCl CF 8 mg, tabletten
English: Bromohexine hydrochloride
Danish: Italy bromhexinhydrochlorid Flutoxil
English: Croatia bromhexinum Bisolvon 2 mg/ml otopina 2 mg/ml solution for oral use oral use
Danish: Bisolvon 2 mg/ml otopina
English: Ambroxine oromucosal spray inhalation use
Danish: Belgium ambroxolhydrochlorid Ambroxine mundhulespray til inhalation
English: Mucosolvan 7,5 mg / 1 mlLösung
Danish: Austria ambroxolhydrochlorid Mucosolvan 7,5 mg / 1 ml - Lösung
English: BROMHEXINE Bisolvon
Danish: Belgium bromhexin chlorhydrat Bisolvon
English: Broomhexine HCl 8=5 PCH, drank 8 mg/5 ml
Danish: 2031 GA HAARLEM The Netherlands bromhexinhydrochlorid Broomhexine HCl 8=5 PCH, drank 8 mg/5 ml
English: Bromhexine Sopharma solution for injection intramuscular use, intravenous use
Danish: Italy bromhexinhydrochlorid Bisolvon injektionsvæske, opløsning injektionsvæske
English: Ambroxol Krewel Meuselbach Tropfen 7,5mg/ml oral drops, solution oral use
Danish: Germany ambroxolhydrochlorid Ambroxol Krewel Meuselbach Tropfen orale dråber, opløsning
English: BROMHEXIN ROMPHARM 2mg/ml oral drops, solution oral use
Danish: Bulgaria bromhexinhydrochlorid Bromhexine Sopharma 2 mg/ml injektionsvæske, opløsning intravenøs anvendelse
English: Mucoangin oromucosal spray oromucosal use
Danish: Belgium ambroxolhydrochlorid Mucoangin mundhulespray orofaryngeal anvendelse
English: Bromhexine Hydrochloride BP
Danish: Belgium bromhexinhydrochlorid Bisolvon
English: Ambro-AbZ 6 mg/ml Lösung zum Einnehmen
Danish: Germany ambroxolhydrochlorid Ambro-AbZ 6 mg/ml Lösung zum
English: NEDAC SORBO Hoesttabletten Broomhexine HCl 8 mg, tabletten
Danish: 2031 GA HAARLEM The Netherlands bromhexinhydrochlorid Broomhexine HCl 8 PCH, tabletten 8 mg
English: Slovak Republic ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Danish: Slovakiet ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany ambroxolhydrochlorid Ambrobene 30 mg 30 mg
English: nebuliser solution inhalation use
Danish: Oral anvendelse til inhalation
English: Mucosolvan Portionsbeutel 30 mg/5 ml
Danish: Germany ambroxolhydrochlorid Mucosolvan Portionsbeutel 30 mg/5 ml
English: Leidapharm Hoestdrank Extra sterk Broomhexine HCl 8 mg/5 ml suikervrij, drank
Danish: Archimedesweg 2 2333 CN LEIDEN The Netherlands bromhexinhydrochlorid Leidapharm Hoestdrank Extra sterk Broomhexine HCl 8 mg/5 ml suikervrij, drank
English: Ambrobene Extra Strength 6mg/ml Oral Solution
Danish: 3542 DR Utrecht The Netherlands ambroxolhydrochlorid Ambrobene Extra Strength 6mg/ml Oral Solution
English: Ambroxol hydrochloride Theophylline
Danish: Cyprus ambroxolhydrochlorid Hyvotex
English: Flavamed Hustenlöser 30 mg/5 ml Lösung zum Einnehmen
Danish: Germany ambroxolhydrochlorid Flavamed Hustenlöser 30 mg/5 ml Lösung zum Einnehmen
English: Mucoangin Citroen 20 mg, zuigtabletten lozenge
Danish: 1817 MS Alkmaar The Netherlands ambroxolhydrochlorid Mucoangin Citroen 20 mg, zuigtabletten sugetablet
English: Ambroxol acis Saft
Danish: Germany ambroxolhydrochlorid Ambroxol acis Saft
English: Ambroxol Inhalat nebuliser solution inhalation use
Danish: Germany ambroxolhydrochlorid Ambroxol Inhalat til inhalation
English: S.M.
Danish: Grækenland S.M.
English: Ambrohexal Hustenlöser retard 75mg prolonged-release capsule, hard
Danish: Spain ambroxolhydrochlorid Motosol Retard 75 mg cápsulas de liberación prolongada depotkapsel, hård oral anvendelse
English: ALIUD PHARMA GmbH Gottlieb-Daimler-Straße 19, 89150 Laichingen Germany
Danish: ALIUD PHARMA GmbH Gottlieb-Daimler-Straße 19, 89150 Laichingen Germany ambroxolhydrochlorid AMBROXOL AL KVAPKY 7,5 mg/1 ml dråber til oral anvendelse
English: Motosol 3 mg/ ml jarabe 3 mg/ml
Danish: Spain ambroxolhydrochlorid Motosol 3 mg/ ml jarabe
English: Mucoangin Cassis pastille
Danish: Belgium ambroxolhydrochlorid Mucoangin Cassis pastil
English: BROMHEXINE-GRINDEKS 4 mg/5 ml
Danish: Italy bromhexinhydrochlorid Bromexina Germed 4 mg/5 ml
English: Ambrohexal S Brausetablette effervescent tablet oral use
Danish: Belgium ambroxolhydrochlorid Surbronc granulat til oral opløsning
English: Ambroxol "Aponova" 60 mg - Brausetabletten effervescent tablet oral use
Danish: Austria ambroxolhydrochlorid Ambroxol "Aponova" 60 mg
English: D-55216 Ingelheim am Rhein Germany bromhexine hydrochloride
Danish: D-55216 Ingelheim am Rhein Germany bromhexinhydrochlorid BISOLVON 4 mg/5 ml sirup
English: EU (MA) number Invented name
Danish: EU-nummer Særnavn Styrke Lægemiddelform Dyrearter, som lægemidlet er beregnet til
English: Withdrawal period
Danish: Tilbageholdelsestid enkeltdosisbe holder
English: This medicinal product is authorized in the Member States of the EEA under the following names:
Danish: Dette lægemiddel er godkendt i EØS medlemslande under følgende navne:
English: What is asthma?
Danish: Hvad er astma?
English: A treatment effect was achieved after the first dose.
Danish: Behandlingseffekt blev opnået efter første dosis.
English: FURTHER INFORMATION).
Danish: YDERLIGERE OPLYSNINGER).
English: Patients who develop these symptoms should be reassessed and their treatment regimens evaluated.
Danish: Patienter som udvikler disse symptomer, bør revurderes, og deres behandlingsregimer evalueres.
English: There were no gender or race-related differences in the effect.
Danish: Der var ingen køns- eller racebestemte forskelle i virkningen.
English: With prolonged treatment, the safety profile did not change in these patients either.
Danish: Med forlænget behandling ændrede sikkerhedsprofilen sig heller ikke for disse patienter.
English: Do not give a double dose to make up for a forgotten dose.
Danish: Giv ikke en dobbeltdosis som erstatning for en glemt dosis.
English: Your doctor will assess whether you can take SINGULAIR during this time.
Danish: Deres læge vil vurdere, om De kan tage SINGULAIR i denne periode.
English: Additionally, while the medicine has been on the market, the following have been reported:
Danish: Derudover er der, mens medicinen har været på markedet, set:
English: All other sections of the SPCs will be harmonised as approved in the Mutual Recognition Procedure.
Danish: Alle andre afsnit i produktresuméet vil blive harmoniseret som godkendt i proceduren for gensidig anerkendelse.
English: Sixty percent of patients were not on any other controller therapy.
Danish: 60% af patienterne var ikke i anden kontrolbehandling.
English: No abnormalities were seen in rats.
Danish: Der sås ingen abnormiteter hos rotter.
English: Both were of doubleblind, randomised, parallel-group type.
Danish: Begge var af typen dobbeltblind, randomiseret og med parallelgrupper.
English: 00-867 Warszawa Poland
Danish: 00-867 Warszawa Polen
English: IMPORTANT: Never store any granule/food mixture for use at a later time.
Danish: VIGTIGT: Gem aldrig en blanding af mad og granulat til senere brug.
English: The indications given in these SPCs are the most restrictive among the approved indications in EU member states, and are approved in the most number of countries.
Danish: Indikationerne i disse produktresuméer er de mest restriktive blandt de godkendte indikationer i EU-medlemslandene og er godkendt i det største antal lande.
English: 1407 Sofia Bulgaria
Danish: 1407 Sofia Bulgarien
English: Montelukast is rapidly absorbed following oral administration.
Danish: Montelukast absorberes hurtigt efter oral administration.
English: No dosage adjustment within this age group is necessary.
Danish: Justering af dosis er ikke nødvendig i denne aldersgruppe.
English: Montelukast has been evaluated in clinical studies as follows:
Danish: Montelukast er evalueret i kliniske undersøgelser som følger:
English: The oral bioavailability and Cmax are not influenced by a standard meal.
Danish: Den orale biotilgængelighed og Cmax påvirkes ikke af et standardmåltid.
English: Montelukast is more than 99% bound to plasma proteins.
Danish: Montelukast bindes mere end 99% til plasmaproteiner.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF SINGULAIR AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUME AF DEN FAGLIGE VURDERING AF SINGULAIR OG TILKNYTTEDE NAVNE (SE BILAG I)
English: The mean oral bioavailability is 64%.
Danish: Den gennemsnitlige, orale biotilgængelighed er 64%.
English: However, liquids may be taken subsequent to administration.
Danish: Væske kan dog indtages efter administration.
English: These cases usually, but not always, have been associated with the reduction or withdrawal of oral corticosteroid therapy.
Danish: Disse tilfælde har som regel, men ikke altid, været sat i forbindelse med reduktion eller seponering af oral kortikosteroidbehandling.
English: It is a leukotriene-1 receptor antagonist.
Danish: Det er en leukotrien-1-receptorantagonist.
English: This dose is equivalent to 25,000 times the recommended daily adult human dose (based on an adult patient weight of 50 kg).
Danish: Denne dosis svarer til 25.000 gange den anbefalede daglige dosis til voksne mennesker (baseret på en voksen patientvægt på 50 kg).
English: However, individual responses to medication may vary.
Danish: Det er dog forskelligt, hvordan man reagerer på medicin.
English: Via G. Fabbroni, 6 00191 Roma Italy
Danish: Via G. Fabbroni, 6 00191 Rom Italien
English: Important information about some of the ingredients of SINGULAIR
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i SINGULAIR
English: Treatment should be discontinued if a lack of response is observed.
Danish: Behandlingen bør afbrydes, hvis der observeres manglende respons.
English: The contribution of metabolites to the therapeutic effect of montelukast is minimal.
Danish: Metabolitternes bidrag til den terapeutiske virkning af montelukast er minimal.
English: Read all of this leaflet carefully before your child starts taking this medicine.
Danish: Læs denne indlægsseddel grundigt, inden Deres barn begynder at tage medicinen.
English: Ask your doctor or pharmacist for more information about side effects.
Danish: Spørg Deres læge eller på apoteket om mere information om bivirkninger.
English: Like all medicines, SINGULAIR can cause side effects, although not everybody gets them.
Danish: SINGULAIR kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Your child should take SINGULAIR every evening.
Danish: • Deres barn skal tage SINGULAIR hver aften.
English: Patients should be periodically evaluated for their asthma control.
Danish: Patienter bør evalueres periodisk med henblik på deres astmakontrol.
English: Skanstes 13, second floor, LV- 1013, Riga Latvia
Danish: Skanstes 13, second floor, LV- 1013, Riga Letland
English: Istituto Gentili S.p.A Via B. Croce, 37 56125 Pisa Italy
Danish: Istituto Gentili S.p.A Via B. Croce, 37 56125 Pisa Italien
English: The effect of montelukast on asthma was modest, but consistent across the spectrum of variables, and in line with results obtained from studies on adults and older children.
Danish: Effekten af montelukast på astma var beskeden, men konsistent i hele spektret af variabler og på linje med de resultater, der blev opnået i undersøgelser med voksne og større børn.
English: The mean oral bioavailability is 73% and is decreased to 63% by a standard meal.
Danish: Den gennemsnitlige, orale biotilgængelighed er 73% og falder til 63% ved indtagelse af standardmåltid.
English: Some medicines may affect how SINGULAIR works, or SINGULAIR may affect how your child's other medicines work.
Danish: Nogle former for medicin kan påvirke virkningen af SINGULAIR, eller SINGULAIR kan indvirke på, hvordan Deres barns øvrige medicin virker.
English: MSD Magyarország Kft. 1123 Budapest, Alkotás u. 50., Hungary
Danish: MSD Magyarország Kft. 1123 Budapest, Alkotás u. 50., Ungarn
English: The dosage is the same for both male and female patients.
Danish: Dosis er den samme for begge køn.
English: This effect was consistent throughout the 12week study period.
Danish: Denne effekt var vedvarende gennem hele 12-ugers undersøgelsen.
English: The steady-state volume of distribution of montelukast averages 8-11 liters.
Danish: Steady-state-distributionsvolumen af montelukast er 8-11 liter i gennemsnit.
English: After opening the sachet, the full dose of SINGULAIR granules must be administered immediately (within 15 minutes).
Danish: Efter åbning af brevet skal den fulde dosis SINGULAIR granulat administreres straks (inden for 15 minutter).
English: If an acute attack occurs, a short-acting inhaled β-agonist should be used.
Danish: Hvis der opstår et akut astmaanfald, bør korttidsvirkende inhalations-β-agonist anvendes.
English: 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.
Danish: Efter oral dosis af radioaktivt mærket montelukast blev 86% af radioaktiviteten genvundet i 5 dages fæcesindsamling og <0,2% blev genvundet i urinen.
English: However, in very rare cases, individuals have reported drowsiness or dizziness.
Danish: Der er imidlertid, i meget sjældne tilfælde, rapporteret om døsighed eller svimmelhed.
English: Singulair 4 mg oral granules was approved by 16 member states (not by AT, BE, CZ, DK, FR, HU, NL, PL, SK) in MRP in 2002.
Danish: Singulair 4 mg oralt granulat blev godkendt af 16 medlemslande (ikke af AT, BE, CZ, DK, FR, HU, NL, PL, SK) i proceduren for gensidig anerkendelse i 2002.
English: The clinical and laboratory findings observed were consistent with the safety profile in adults and paediatric patients.
Danish: De kliniske og laboratoriemæssige fund var konsistente med sikkerhedsprofilen hos voksne og pædiatriske patienter.
English: Limited data from available pregnancy databases do not suggest a causal relationship between SINGULAIR and malformations (i.e. limb defects) that have been rarely reported in worldwide post marketing experience.
Danish: Begrænsede data fra tilgængelige graviditetsdatabaser tyder ikke på, at der er en årsagssammenhæng mellem brug af SINGULAIR og medfødte misdannelser (dvs. ekstremitetsdefekter), som på verdensplan er rapporteret sjældent efter markedsføring.
English: Furthermore, the latest variation procedure was finalised on 10th September 2007, and the SPCs that were then approved are in line with the proposals of the MAH in this referral.
Danish: Desuden afsluttedes den seneste procedure vedrørende en ændring den 10. september 2007, og de produktresuméer, der var godkendt på dette tidspunkt, er i overensstemmelse med forslag, som indehaveren af markedsføringstilladelsen stiller i den indbragte sag.
English: This effect was not seen at the recommended dose of 10 mg once daily.
Danish: Denne effekt sås ikke ved den anbefalede daglige dosis på 10 mg.
English: The therapeutic effect of SINGULAIR on parameters of asthma control occurs within one day.
Danish: Den terapeutiske effekt af SINGULAIR på astmakontrollerende parametre indtræder i løbet af en dag.
English: Both montelukast and fluticasone also improved asthma control on secondary variables assessed over the 12 month treatment period:
Danish: Både montelukast og fluticason forbedrede også astmakontrollen på sekundære variable vurderet over den 12 måneders behandlingsperiode:
English: Montelukast is an orally active compound which binds with high affinity and selectivity to the CysLT1 receptor.
Danish: Montelukast er et oralt aktivt stof, som med stor affinitet og selektivitet binder sig til CysLT1 receptoren.
English: Body System Class
Danish: SYSTEMORGANKLASSE
English: Corp clădire C1, Etaj 3, Sector 1, Bucureşti Romania
Danish: Corp clădire C1, Etaj 3, Sector 1, Bukarest Romænien
English: Tell your doctor if your child is taking the following medicines before starting SINGULAIR:
Danish: Fortæl det til lægen hvis Deres barn tager følgende medicin, før De begynder at give SINGULAIR:
English: If mixed with food, SINGULAIR granules must not be stored for future use.
Danish: Hvis det er blandet med mad, må SINGULAIR granulat ikke opbevares til senere brug.
English: There are no data on the pharmacokinetics of montelukast in patients with severe hepatic insufficiency (Child-Pugh score >9).
Danish: Der er ingen data vedrørende montelukasts farmakokinetik hos patienter med alvorlig leverinsufficiens (Child-Pugh score >9).
English: • This medicine is to be given to a child under adult supervision.
Danish: • Denne medicin bør gives til et barn under opsyn af en voksen person.
English: Patients should be advised to continue taking SINGULAIR even if their asthma is under control, as well as during periods of worsening asthma.
Danish: Patienter bør tilrådes at fortsætte med at tage SINGULAIR, selv når deres astma er under kontrol samt i perioder med forværring af astmaen.
English: However, there were no data of studies comparing montelukast with active treatments in paediatric patients.
Danish: Imidlertid var der ingen data fra undersøgelser, der sammenligner montelukast med aktive behandlinger af pædiatriske patienter.
English: In a small study on 27 paediatric patients it was also shown that montelukast seems to protect paediatric patients against exercise-induced bronchoconstriction.
Danish: I en lille undersøgelse med 27 pædiatriske patienter blev det påvist, at montelukast tilsyneladende beskytter pædiatriske patienter mod anstrengelsesudløst bronkokonstriktion.
English: Leukotrienes cause narrowing and swelling of airways in the lungs.
Danish: Leukotriener forårsager forsnævring og hævelse af luftvejene i lungerne.
English: The sachet should not be opened until ready to use.
Danish: Brevet bør ikke åbnes, før man er klar til at bruge det.
English: This medicinal product is to be given to a child under adult supervision.
Danish: Denne medicin bør gives til et barn under opsyn af en voksen person.
English: - the Summaries of Products Characteristic, labelling, package leaflet and Module 3 proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
Danish: - Produktresuméerne, etiketteringen, indlægssedlen og afsnit 3, som indehaveren af markedsføringstilladelsen har foreslået, er blevet vurderet på baggrund af den indsendte dokumentation og udvalgets faglige drøftelse.
English: Two long term studies to support the monotherapy indication were presented.
Danish: Der blev fremlagt to langtidsundersøgelser, der underbygger indikationen monoterapi.
English: If satisfactory control of asthma is not achieved at follow-up (usually within one month), the need for an additional or different anti-inflammatory therapy based on the step system for asthma therapy should be evaluated.
Danish: Hvis der ikke er opnået tilfredsstillende kontrol af astma ved opfølgningsbesøg (sædvanligvis inden for en måned), bør behovet for supplerende og anden antiinflammatorisk behandling, baseret på trinvis astmabehandling, evalueres.
English: Animal studies do not indicate harmful effects with respect to effects on pregnancy or embryonal/foetal development.
Danish: Graviditet Dyreundersøgelser har ikke indikeret skadelige virkninger på graviditet eller fosterudvikling.
English: • sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.
Danish: • Følsomme luftveje som reagerer på mange ting, for eksempel cigaretrøg, pollen, kold luft eller fysisk aktivitet.
English: Therefore, montelukast is not anticipated to markedly alter the metabolism of medicinal products metabolized by this enzyme (e.g., paclitaxel, rosiglitazone, and repaglinide.)
Danish: Derfor forventes det ikke, at montelukast markant ændrer metaboliseringen af lægemidler metaboliseret via dette enzym (f.eks. paclitaxel, rosiglitazon og repaglinid).
English: After careful deliberations, the CHMP considered that the clinical data to support the add-on therapy in very young children are sufficient for approval, taking into account that this formulation was approved for use in children aged 6 months to 2 years in approximately 52 countries, including 17 of 27 European Union (EU) Member States (first approval in 2002) plus Iceland and Norway.
Danish: Efter grundige overvejelser besluttede CHMP, at de kliniske data, der underbyggede tillægsbehandlingen hos meget små børn, er tilstrækkelige til en godkendelse, når det tages i betragtning, at denne formulering blev godkendt til brug hos børn i alderen 6 måneder til 2 år i ca. 52 lande, herunder 17 ud af 27 EU-lande (første godkendelse i 2002) plus Island og Norge.