FrancophonIA/ELRC3.0 huggingface dataset:
English: The major part of a dose of formoterol is transformed by liver metabolism followed by renal elimination.
Danish: Størstedelen af en dosis formoterol metaboliseres i leveren og udskilles efterfølgende gennem nyrerne.
English: In patients using potent CYP3A4 inhibitors, a budesonide/formoterol fumarate fixed-dose combination is not recommended.
Danish: Det anbefales, at patienter, der anvender potente CYP3A4hæmmere, ikke anvender en fastdosiskombination af budesonid/formoterolfumarat.
English: • Medicines for a fast or uneven heartbeat (such as quinidine, disopyramide and procainamide).
Danish: • Lægemidler til behandling af hurtig eller uregelmæssig hjerterytme (såsom quinidin, disopyramid og procainamid).
English: Also tell your doctor,pharmacist or nurse if you are going to have a general anaesthetic for an operation or for dental work.
Danish: Fortæl også lægen, apotekspersonalet eller sundhedspersonalet, hvis du skal bedøves i forbindelse med operation eller tandbehandling.
English: Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for long periods.
Danish: Systemiske virkninger af inhaleret kortikosteroid kan forekomme, især ved høje doser ordineret i lange perioder.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS INHALER
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER INHALATOR
English: Paradoxical bronchospasm may occur, with an immediate increase in wheezing and shortness of breath, after dosing.
Danish: Paradoks bronkospasme kan forekomme efter dosering med en øjeblikkelig forværring af hvæsen og åndenød.
English: No information regarding the effect of a budesonide/formoterol fumarate dihydrate fixed-dose combination at higher doses is available.
Danish: Der findes ingen oplysninger vedrørende indvirkningen af en fastdosiskombination af budesonid/formoterolfumaratdihydrat ved højere doser.
English: Adults (18 years and older): 1-2 inhalations twice daily.
Danish: Voksne (fra og med 18 år): 1-2 inhalationer to gange dagligt.
English: Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation with Budesonide/Formoterol Teva Pharma B.V.
Danish: Patienterne skal informeres om at fortsætte behandlingen og søge læge, hvis astmasymptomerne forbliver ukontrollerede eller forværres efter påbegyndelse af Budesonid/Formoterol Teva Pharma B.V.-behandling.
English: Possible side effects (page 18)
Danish: (side 9) Bivirkninger (side 18)
English: Pharmacodynamic interactions β adrenergic blockers can weaken or inhibit the effect of formoterol.
Danish: Betablokkere kan svække eller hæmme virkningen af formoterol.
English: Keep the mouthpiece cover closed and use within 6 months of removing from foil wrapping.
Danish: Hold mundstykkets låg lukket, og anvend produktet inden for 6 måneder efter, det er taget ud af folien.
English: Metabolism and nutrition disorders
Danish: Metabolisme og ernæring Sjælden
English: You might experience symptoms such as a stuffy or runny nose, weakness or joint or muscle pain and rash (eczema).
Danish: Du kan opleve symptomer som tilstoppet næse eller snue, svaghed eller led- eller muskelsmerter og udslæt (eksem).
English: • Keep this medicine out of the sight and reach of children.
Danish: • Opbevar lægemidlet utilgængeligt for børn.
English: Asthma symptoms
Danish: Astmasymptomer
English: Paradoxical bronchospasm
Danish: Bronkospasme Meget sjælden Paradoks bronkospasme
English: • Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly if you use high doses for a long time.
Danish: • Inhalerede kortikosteroider kan påvirke den normale produktion af steroidhormoner i din krop,
English: When used chronically in excessive doses, systemic glucocorticosteroid effects, such as hypercorticism and adrenal suppression, may appear.
Danish: Ved kronisk anvendelse af meget store doser kan der forekomme systemiske glukokortikoidvirkninger, såsom hyperkorticisme og binyrebarksuppression.
English: If necessary you may wipe the mouthpiece of your Spiromax after use with a dry cloth or tissue.
Danish: Hvis det er nødvendigt, kan du aftørre mundstykket med en tør klud eller serviet efter brug.
English: In animal studies formoterol has caused adverse reactions in reproduction studies at very high systemic exposure levels (see section 5.3).
Danish: I reproduktionsstudier hos dyr har formoterol forårsaget uønskede virkninger ved meget høj eksponering efter systemiske doser (se pkt.
English: This medicinal product is not recommended for use in children and adolescents under the age of 18 years.
Danish: Lægemidlet anbefales ikke til brug hos børn og unge under 18 år.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 doses
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 60 doser
English: Transfer from oral therapy
Danish: Skift fra oral behandling
English: The most common adverse reactions are pharmacologically predictable adverse reactions of β2 adrenoceptor agonist therapy, such as tremor and palpitations.
Danish: De hyppigste bivirkninger er farmakologisk forudsigelige bivirkninger ved behandling med β2-agonist, såsom tremor og palpitationer.
English: Then breathe out gently (do not breathe out through the inhaler).
Danish: Ånd forsigtigt ud (ånd ikke ud gennem inhalatoren).
English: Each inhaler contains 60 doses and is foil-wrapped.
Danish: Hver inhalator indeholder 60 doser og er indpakket i folie.
English: Clinical studies in adults have shown that the addition of formoterol to budesonide improved asthma symptoms and lung function, and reduced exacerbations.
Danish: Vedligeholdelsesbehandling af astma med budesonid/formoterol Kliniske studier hos voksne har vist, at tillæg af formoterol til budesonid forbedrede astmasymptomer og lungefunktion samt reducerede eksacerbationer.
English: In two 12-week studies the effect on lung function of budesonide/formoterol was equal to that of the free combination of budesonide and formoterol, and exceeded that of budesonide alone.
Danish: I to 12-ugers studier var budesonids/formoterols indvirkning på lungefunktionen den samme som virkningen af kombination af budesonid og formoterol som enkeltstoffer og bedre end budesonid alene.
English: Possible systemic effects include Cushing´s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children) (see section 4.8).
Danish: Eventuelle systemiske påvirkninger omfatter Cushings syndrom, cushingoide træk, binyrebarksuppression, væksthæmning hos børn og unge, nedsat knogletæthed, grå stær og glaukom og i sjældnere tilfælde en række psykologiske og adfærdsmæssige påvirkninger, herunder psykomotorisk hyperaktivitet, søvnforstyrrelser, angst, depression eller aggression (særligt hos børn) (se pkt.
English: If your doctor feels that you need a lower dose than is available from your Budesonide/Formoterol Teva Pharma B.V., your doctor may prescribe an alternative inhaler containing the same active substances as your Budesonide/Formoterol Teva Pharma B.V. but with a lower dose of the corticosteroid.
Danish: Hvis din læge mener, at du har brug for en lavere dosis, end der er tilgængelig med din Budesonid/Formoterol Teva Pharma B.V., kan din læge ordinere en anden inhalator, som indeholder de samme aktive stoffer som Budesonid/Formoterol Teva Pharma B.V., men med en lavere dosis kortikosteroid.
English: • If you get pregnant while using Budesonide/Formoterol Teva Pharma B.V., do NOT stop using Budesonide/Formoterol Teva Pharma B.V. but talk to your doctor immediately.
Danish: • Hvis du bliver gravid, mens du bruger Budesonid/Formoterol Teva Pharma B.V., skal du IKKE holde op med at bruge Budesonid/Formoterol Teva Pharma B.V., men straks tale med din læge.
English: If you feel you are getting breathless or wheezy while using Budesonide/Formoterol Teva Pharma B.V., you should continue to use Budesonide/Formoterol Teva Pharma B.V. but go to see your doctor as soon as possible, as you may need additional treatment.
Danish: Hvis du føler, at du bliver forpustet eller trækker vejret med en hvæsende lyd, mens du bruger Budesonid/Formoterol Teva Pharma B.V., skal du fortsætte med at bruge Budesonid/Formoterol Teva Pharma B.V., men søge læge så hurtigt som muligt, da du måske har brug for yderligere behandling.
English: Budesonide has a high systemic clearance (approximately 1.2 L/min) and the plasma elimination half-life after i.v.
Danish: Budesonid har en høj systemisk clearance (ca. 1,2 l/min), og plasmahalveringstiden efter intravenøs dosering er i gennemsnit 4 timer.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp lactase deficiency) eller glucose/galactosemalabsorption.
English: • Medicines called monoamine oxidase inhibitors (such as phenelzine, furazolidone and procardazine).
Danish: • Lægemidler betegnet monoaminoxidasehæmmere (såsom phenelzin, furazolidon og procardazin).
English: Some patients may require up to a maximum of 4 inhalations twice daily.
Danish: Nogle patienter kan have behov for op til højst 4 inhalationer to gange dagligt.
English: A separate rapid-acting bronchodilator should be considered for such prophylactic use .
Danish: Til sådanne situationer bør en separat hurtigtvirkende bronkodilator overvejes.
English: If you get any side effects, talk to your doctor,pharmacist or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, apoteket eller sundhedspersonalet.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 120 doses
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 120 doser
English: Some patients may require up to a maximum of 2 inhalations twice daily.
Danish: Nogle patienter kan have behov for op til højst 2 inhalationer to gange dagligt.
English: • Medicines for thyroid problems (such as levothyroxine).
Danish: • Lægemidler mod problemer med skjoldbruskkirtlen (såsom levothyroxin).
English: Paradoxical bronchopasm responds to a rapid-acting inhaled bronchodilator and should be treated straightaway (see section 4.8).
Danish: Paradoks bronkospasme reagerer på en hurtigtvirkende inhaleret bronkodilator og skal behandles med det samme (se pkt.
English: If you forget to take a dose, take it as soon as you remember.
Danish: Hvis du glemmer at tage en dosis, skal du tage den, så snart du kommer i tanker om det. Du må dog ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: In animal studies glucocorticosteroids have been shown to induce malformations (see section 5.3).
Danish: Det er blevet påvist i dyrestudier, at glukokortikoider fremkalder misdannelser (se pkt.
English: - The other ingredient is lactose monohydrate (see section 2 under ‘Budesonide/Formoterol Teva Pharma
Danish: - Øvrige indholdsstoffer: lactosemonohydrat (se punkt 2 under 'Budesonid/Formoterol Teva Pharma B.V.
English: Hold your inhaler with the semi-transparent wine red mouthpiece cover at the bottom.
Danish: Hold din inhalator med mundstykkets halvgennemsigtige, vinrøde låg nedad.
English: Each inhaler contains 120 doses and is foil-wrapped.
Danish: Hver inhalator indeholder 120 doser og er indpakket i folie.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FOIL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER FOLIE
English: Breathe: Place the mouthpiece between the teeth with the lips closed around the mouthpiece, do not bite the mouthpiece of the inhaler.
Danish: Indånding: Placer mundstykket mellem tænderne med læberne lukket omkring mundstykket.
English: When it is appropriate to titrate down to a lower strength than is available for Budesonide/Formoterol Teva Pharma B.V., a change to an alternative fixed-dose combination of budesonide and formoterol fumarate containing a lower dose of the inhaled corticosteroid is required.
Danish: Når det er hensigtsmæssigt at titrere ned til en lavere styrke, end der er tilgængeligt for Budesonid/Formoterol Teva Pharma B.V., er det nødvendigt at skifte til en alternativ fastdosiskombination af budesonid og formoterolfumarat, som indeholder en lavere dosis af inhaleret kortikosteroid.
English: There are no data available for use of a fixed-dose combination of budesonide and formoterol fumarate dihydrate in patients with hepatic or renal impairment.
Danish: Der findes ingen data for anvendelse af en fastdosiskombination af budesonid og formoterolfumaratdihydrat hos patienter med nedsat lever- eller nyrefunktion.
English: If any of the above applies to you, or if you are not sure, talk to your doctor,pharmacist or nurse before using Budesonide/Formoterol Teva Pharma B.V.
Danish: Hvis noget af ovenstående gælder for dig, eller hvis du ikke er sikker, så tal med din læge, apotekspersonalet eller sundhedspersonalet, før du bruger Budesonid/Formoterol Teva Pharma B.V.
English: • The dose indicator tells you how many doses (inhalations) are left in your inhaler, starting with 60
Danish: • Dosisindikatoren fortæller dig, hvor mange doser (inhalationer) der er tilbage i inhalatoren.
English: Recovery may take a considerable amount of time after cessation of oral steroid therapy and hence oral steroid-dependent patients transferred to inhaled budesonide may remain at risk from impaired adrenal function for some considerable time.
Danish: Efter seponering af oral steroidbehandling kan det vare længe, før der opnås restitution, og patienter, som er afhængige af oralt steroid, men overgår til inhaleret budesonid, kan derfor have risiko for nedsat binyrebarkfunktion i længere tid.
English: or - in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.
Danish: eller - hos patienter, der allerede er velkontrollerede på både inhaleret kortikosteroid og langtidsvirkende β2-agonist.
English: Patients should be advised to have their rescue inhaler available at all times.
Danish: Patienterne skal informeres om altid at have deres anfaldsmedicin på sig.
English: Aggression, psychomotor hyperactivity, anxiety, sleep disorders
Danish: Ikke almindelig Aggression, psykomotorisk hyperaktivitet, angst,
English: • Xanthine medicines (such as theophylline or aminophylline).
Danish: • Lægemidler, der indeholder xanthin (såsom theophyllin eller aminophyllin).
English: Side panel: For use in adults 18 years of age and older only.
Danish: Kartonside: Må kun anvendes til voksne fra og med 18 år.
English: 2 years.
Danish: hver dag.
English: Possible systemic effects include Cushing´s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma.
Danish: Eventuelle systemiske virkninger inkluderer Cushings syndrom, cushingoide træk, binyrebarksuppression, væksthæmning hos børn og unge, nedsat knogletæthed, grå stær og glaukom.
English: Excipient(s) with known effect: Each dose contains approximately 10 milligrams of lactose (as monohydrate) .
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver dosis indeholder cirka 5 milligram lactose (som monohydrat).
English: Your doctor may increase this to 4 inhalations, twice a day.
Danish: Din læge kan øge dette til 4 inhalationer 2 gange dagligt.
English: 1 or 2 inhalations (actuations), twice a day.
Danish: 1 eller 2 inhalationer (pust) 2 gange dagligt.
English: You should speak to your doctor if you are concerned as to whether you should continue to use Budesonide/Formoterol Teva Pharma B.V.
Danish: Tal med din læge, hvis du er i tvivl om, hvorvidt du skal fortsætte med at bruge Budesonid/Formoterol Teva Pharma B.V.
English: Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods.
Danish: Systemiske påvirkninger kan opstå efter anvendelse af alle inhalationskortikosteroider, især ved høje doser ordineret i længere perioder.
English: Budesonide/Formoterol Teva Pharma B.V. should be discontinued immediately, the patient should be assessed and an alternative therapy is instituted if necessary (see section 4.4).
Danish: skal straks seponeres, patienten skal udredes og alternativ behandling iværksættes, hvis det er nødvendigt (se pkt.
English: • Fast heartbeat.
Danish: • Hurtig puls.
English: Your doctor may increase this to 2 inhalations, twice a day.
Danish: Din læge kan øge dette til 2 inhalationer 2 gange dagligt.
English: Since Budesonide/Formoterol Teva Pharma B.V. contains both budesonide and formoterol, the same pattern of adverse reactions as reported for these substances may occur.
Danish: indeholder både budesonid og formoterol, kan det samme bivirkningsmønster, som er indberettet for disse stoffer, forekomme.
English: Not for use in children or adolescents under 18 years of age.
Danish: Må ikke anvendes til børn og unge under 18 år.
English: The safety and efficacy of Budesonide/Formoterol Teva Pharma B.V. in children, 12 years and younger and adolescents, 13 to 17 years of age has not yet been established.
Danish: 's sikkerhed og virkning hos børn i alderen 12 år og derunder og unge i alderen 13-17 år er endnu ikke klarlagt.
English: Variations in blood pressure
Danish: Meget sjælden Blodtryksvariationer
English: Paradoxical bronchospasm may occur very rarely, affecting less than 1 in 10,000 people, with an immediate increase in wheezing and shortness of breath after dosing.
Danish: Paradoks bronkospasme med en akut forværring af hvæsen og åndenød efter dosering forekommer meget sjældent, idet det påvirker færre end 1 ud af 10.000 mennesker.
English: If there is any reason to suppose that adrenal function is impaired from previous systemic steroid therapy, care should be taken when transferring patients to a budesonide/formoterol fumarate fixed-dose combination therapy.
Danish: Hvis der er risiko for, at binyrebarkfunktionen er svækket som følge af tidligere systemisk steroidbehandling, skal der udvises forsigtighed, når patienten skifter til kombinationsbehandling med budesonid/formoterolfumarat med fast dosis.
English: Do not try to take your inhaler apart, remove or twist the mouthpiece cover, it is fixed to your inhaler and must not be taken off. Do not use your Spiromax if it has been damaged or if the mouthpiece has come apart from your Spiromax.
Danish: Forsøg ikke at skille din inhalator ad, eller at fjerne eller vride mundstykkets låg.
English: If you use more Budesonide/Formoterol Teva Pharma B.V. than you should, contact your doctor, pharmacist or nurse for advice.
Danish: Hvis du har brugt for meget Budesonid/Formoterol Teva Pharma B.V., skal du kontakte lægen, apotekspersonalet eller sundhedspersonalet.
English: Patients should be reassessed regularly by their prescriber/healthcare provider so that the dose of Budesonide/Formoterol Teva Pharma B.V. remains optimal.
Danish: Patienterne bør revurderes med jævne mellemrum af deres læge/sundhedsperson, således at dosis af Budesonid/Formoterol Teva Pharma B.V.
English: Budesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: -in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.
Danish: er indiceret til behandling af astma, hvor det er hensigtsmæssigt at anvende en kombination (inhaleret kortikosteroid og langtidsvirkende β2-agonist): - hos patienter, der ikke er tilstrækkeligt velkontrollerede med inhaleret kortikosteroid og inhaleret korttidsvirkende β2-agonister ved behov.
English: Effects on bone density
Danish: Påvirkning af knogletæthed
English: Common: may affect up to 1 in 10 people
Danish: Almindelige: kan påvirke op til 1 ud af 10 personer
English: Hypersensitivity to the active substances or the excipient listed in section 6.1.
Danish: Overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpestofferne anført i pkt.
English: These effects are much less likely to occur with inhalation treatment than with oral corticosteroids.
Danish: Disse påvirkninger er langt mindre tilbøjelige til at forekomme i forbindelse med inhalationsbehandling end med oral behandling.
English: These effects are much less likely to occur than with oral corticosteroids.
Danish: Disse virkninger er langt sjældnere end med oralt kortikosteroid.
English: Palpitations
Danish: Palpitationer
English: Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, The Netherlands.
Danish: Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Holland.
English: • you are diabetic.
Danish: • Du har sukkersyge.
English: Very rare side effects: may affect up to 1 in 10,000 people
Danish: Meget sjældne bivirkninger: kan påvirke op til 1 ud af 10.000 personer
English: Cushing´s syndrome, adrenal suppression, growth retardation, decrease in bone mineral density
Danish: Det endokrine system Meget sjælden Cushings syndrom, binyrebarksuppression, væksthæmning, nedsat knogletæthed
English: If you have been taking steroid tablets for your asthma, your doctor may reduce the number of tablets that you take, once you start to use Budesonide/Formoterol Teva Pharma B.V..
Danish: Hvis du har taget steroidtabletter for din astma, kan lægen reducere det antal tabletter, du tager, når du begynder at bruge Budesonid/Formoterol Teva Pharma B.V..
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht,The Netherlands 12.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Teva Pharma B.V., Computerweg 10, 3542, DR Utrecht, Holland
English: If you have been taking steroid tablets for your asthma, your doctor may reduce the number of tablets that you take, once you start to use Budesonide/Formoterol Teva Pharma B.V.
Danish: Hvis du har taget steroidtabletter for din astma, kan lægen reducere det antal tabletter, du tager, når du begynder at bruge Budesonid/Formoterol Teva Pharma B.V.
English: Talk to your doctor,pharmacist or nurse before taking Budesonide/Formoterol Teva Pharma B.V. if
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Budesonid/Formoterol Teva Pharma B.V., hvis
English: Budesonide/Formoterol Teva Pharma B.V. contains formoterol and budesonide, which have different modes of action and show additive effects in terms of reduction of asthma exacerbations.
Danish: indeholder formoterol og budesonid, som har forskellige virkningsmekanismer og udviser additiv virkning med hensyn til reduktion af astmaeksacerbationer.
English: Adrenal function
Danish: Binyrebarkfunktion
English: Headache, tremor
Danish: Tremor, hovedpine, palpitationer.
English: Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of Budesonide/Formoterol Teva Pharma B.V.
Danish: Når din astma er velkontrolleret, kan din læge finde det hensigtsmæssigt gradvist at reducere Budesonid/Formoterol Teva Pharma B.V.-dosen.
English: Budesonide/formoterol maintenance therapy
Danish: budesonid/formoterolfumaratdihydrat
English: Budesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:
Danish: er indiceret til behandling af astma, hvor det er hensigtsmæssigt at anvende en kombination (inhaleret kortikosteroid og langtidsvirkende β2-agonist):
English: Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Budesonide/Formoterol Teva Pharma B.V.
Danish: Når astmasymptomerne er under kontrol, kan det overvejes gradvist at reducere dosis af Budesonid/Formoterol Teva Pharma B.V.