FrancophonIA/ELRC3.0 huggingface dataset:
English: • Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting β2 adrenoceptor agonists' or ‘bronchodilators'.
Danish: • Formoterolfumaratdihydrat tilhører en gruppe lægemidler, der betegnes 'langtidsvirkende beta2agonister' eller 'bronkodilatorer'.
English: If an individual patient should require a combination of doses other than those available in the combination inhaler, appropriate doses of β2 adrenoceptor agonists and/or corticosteroids by individual inhalers should be prescribed.
Danish: Hvis en patient har behov for en anden kombination af doser end den, der findes i kombinationsinhalatoren, bør der ordineres passende doser af β2-agonist og/eller kortikosteroid via individuelle inhalatorer.
English: Each dose contains approximately 5 milligrams of lactose (as monohydrate).
Danish: Hver dosis indeholder cirka 10 milligram lactose (som monohydrat).
English: Oropharyngeal Candida infection usually responds to topical anti-fungal treatment without the need to discontinue the inhaled corticosteroid.
Danish: Orofaryngeal Candida-infektion reagerer sædvanligvis på lokale antimykotika, uden at det er nødvendigt at stoppe behandlingen med inhaleret kortikosteroid.
English: A general insufficient glucocorticosteroid effect should be suspected if, in rare cases, symptoms such as tiredness, headache, nausea and vomiting should occur.
Danish: En generel utilstrækkelig steroidvirkning bør mistænkes, hvis der i sjældne tilfælde forekommer symptomer såsom træthed, hovedpine, kvalme og opkastning.
English: Potent inhibitors of CYP3A4 (e.g. ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone and HIV protease inhibitors) are likely to markedly increase plasma levels of budesonide and concomitant use should be avoided.
Danish: Potente CYP3A4-inhibitorer (f.eks. ketoconazol, itraconazol, voriconazol, posaconazol, clarithromycin, telithromycin, nefazodon og HIV-proteasehæmmere) vil sandsynligvis øge plasmaniveauet af budesonid markant, og samtidig brug bør undgås.
English: The potent CYP3A4 inhibitor ketoconazole, 200 mg once daily, increased plasma levels of concomitantly orally administered budesonide (single dose 3 mg) on average six-fold.
Danish: Den potente CYP3A4-inhibitor ketoconazol, 200 mg én gang dagligt, forhøjede gennemsnitligt plasmaniveauet af samtidigt administreret oralt budesonid (enkeltdosis 3 mg) seks gange.
English: • Write the date you opened the foil pouch on the label of the inhaler.
Danish: • Skriv datoen for, hvornår du åbnede folieposen, på inhalatorens etiket.
English: Treatment with supplementary systematic steroids or inhaled budesonide should not be stopped abruptly.
Danish: Brat seponering af supplerende behandling med systemisk steroid eller inhaleret budesonid bør undgås.
English: 1 inhaler containing 120 doses.
Danish: 1 inhalator indeholdende 120 doser.
English: Rapid reduction in the dose of steroids can induce acute adrenal crisis.
Danish: Hurtig reduktion i steroiddosis kan inducere akut binyrebarkinsufficiens.
English: This helps to prevent asthma symptoms from occurring.
Danish: Dette hjælper med at forebygge astmasymptomer.
English: Concomitant treatment with monoamine oxidase inhibitors including medicinal products with similar properties such as furazolidone and procarbazine may precipitate hypertensive reactions.
Danish: Samtidig behandling med monoaminooxidasehæmmere, herunder lægemidler med tilsvarende egenskaber som f.eks. furazolidon og procarbazin, kan udløse hypertensive reaktioner.
English: Potential effects on bone density should be considered, particularly in patients on high doses for prolonged periods that have co-existing risk factors for osteoporosis.
Danish: Potentielle påvirkninger af knogletæthed bør overvejes, specielt hos patienter, som indtager høje doser over længere perioder og samtidig har risikofaktorer for osteoporose.
English: It works by reducing and preventing swelling and inflammation in your lungs and helps you to breathe more easily.
Danish: Det virker ved at reducere og forebygge hævelse og inflammation (en betændelseslignende reaktion) i lungerne, så du lettere kan trække vejret.
English: If growth is slowed, therapy should be re-evaluated with the aim of reducing the dose of inhaled corticosteroid to the lowest dose at which effective control of asthma is maintained, if possible.
Danish: Ved vækstreduktion skal behandlingen revurderes med henblik på om muligt at reducere dosis af inhaleret kortikosteroid til den laveste dosis, som giver effektiv astmakontrol.
English: • Medicines to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole,
Danish: • Medicin til behandling af infektioner (såsom ketoconazol, itraconazol, voriconazol,
English: Concomitant treatment with quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), monoamine oxidase inhibitors and tricyclic antidepressants can prolong the QTc-interval and increase the risk of ventricular arrhythmias.
Danish: Samtidig behandling med quinidin, disopyramid, procainamid, phenothiaziner, antihistaminer (terfenadin), monoaminoxidasehæmmere og tricykliske antidepressiva kan forlænge QTc-intervallet og øge risikoen for ventrikulære arytmier.
English: Immediate and delayed hypersensitivity reactions, e.g. exanthema, urticaria, pruritus, dermatitis, angioedema and anaphylactic reaction
Danish: Umiddelbare og forsinkede overfølsomhedsreaktioner, f.eks. eksantem, urticaria, pruritus, dermatitis, angioødem og anafylaktisk reaktion
English: A fixed-dose combination therapy of budesonide and formoterol fumarate dihydrate should therefore not be given together with β adrenergic blockers (including eye drops) unless there are compelling reasons.
Danish: Fastdosiskombination af budesonid og formoterolfumaratdihydrat bør derfor ikke gives sammen med betablokkere (herunder øjendråber), medmindre det er tvingende nødvendigt.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.com
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: • Use within 6 months of removing from the foil wrapping.
Danish: • Anvendes inden for 6 måneder efter, at den er taget ud af folien.
English: Budesonide is a glucocorticosteroid which when inhaled has a dose-dependent anti-inflammatory action in the airways, resulting in reduced symptoms and fewer asthma exacerbations.
Danish: Budesonid er et glukokortikoid, som ved inhalation har en dosisafhængig antiinflammatorisk virkning i luftvejene, som resulterer i reducerede symptomer og færre astmaeksacerbationer.
English: • Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone.
Danish: • Tricykliske antidepressiva (såsom amitriptylin) og det antidepressive middel nefazodon.
English: An overdose of formoterol would likely lead to effects that are typical for β2 adrenoceptor agonists: tremor, headache, palpitations.
Danish: En overdosis af formoterol vil sandsynligvis føre til virkninger, der er typiske for β2-agonister: Tremor, hovedpine, palpitationer.
English: • Medicines for Parkinson's disease (such as levodopa).
Danish: • Lægemidler til behandling af Parkinsons sygdom (såsom levodopa).
English: • Medicines called ‘HIV protease inhibitors' (such as ritonavir) to treat HIV infection.
Danish: • Lægemidler betegnet HIV-proteasehæmmere (såsom ritonavir) til behandling af HIV-infektion.
English: Patients should be advised to have their separate rapid-acting bronchodilator reliever inhaler available for rescue use at all times.
Danish: Patienter skal rådes til altid at have deres særskilte hurtigtvirkende bronkodilator tilgængelig til brug ved anfald.
English: Formoterol is a selective β2 adrenoceptor agonist that when inhaled results in rapid and long-acting relaxation of bronchial smooth muscle in patients with reversible airways obstruction.
Danish: Formoterol er en selektiv β2-agonist, som ved inhalation medfører en hurtig og langvarig afslapning af den glatte muskulatur i bronkierne hos patienter med reversibel luftvejsobstruktion.
English: In animal reproduction studies, corticosteroids such as budesonide have been shown to induce malformations (cleft palate, skeletal malformations).
Danish: I reproduktionsstudier med dyr er kortikosteroider såsom budesonid vist at inducere misdannelser (ganespalte, knogledeformiteter).
English: If oropharyngeal thrush occurs, patients should also rinse their mouth with water after the as-needed inhalations.
Danish: Hvis der udvikles trøske, skal patienterne også skylle munden med vand efter inhalationerne taget efter behov.
English: A fixed-dose combination of budesonide and formoterol fumarate dihydrate should be administered with caution in patients with thyrotoxicosis, phaeochromocytoma, diabetes mellitus, untreated hypokalaemia, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders, such as ischaemic heart disease, tachyarrhythmias or severe heart failure.
Danish: Fastdosiskombination af budesonid og formoterolfumaratdihydrat bør administreres med forsigtighed til patienter med tyreotoksikose, fæokromocytom, diabetes mellitus, ubehandlet hypokaliæmi, hypertrofisk obstruktiv kardiomyopati, idiopatisk subvalvulær aortastenose, svær hypertension, aneurisme eller andre alvorlige kardiovaskulære lidelser, såsom iskæmisk hjertesygdom, takyarytmier eller alvorlig hjerteinsufficiens.
English: In studies, mean lung deposition of budesonide after inhalation via the powder inhaler ranged from 32% to 44% of the delivered dose.
Danish: I studier lå den gennemsnitlige lungedeponering af budesonid efter inhalation via pulverinhalatoren mellem 32 % og 44 % af den afgivne dosis.
English: Adults (18 years and older)
Danish: Voksne (fra og med 18 år)
English: Inhaled formoterol is rapidly absorbed and the maximum plasma concentration is reached within 10 minutes after inhalation.
Danish: Formoterol absorberes hurtigt efter inhalation, og maksimal plasmakoncentration nås inden for 10 minutter efter inhalation.
English: During pregnancy, a fixed-dose combination therapy of budesonide and formoterol fumarate dihydrate should only be used when the benefits outweigh the potential risks.
Danish: Under graviditet må behandling med fastdosiskombination af budesonid og formoterolfumaratdihydrat kun bruges, når fordelene opvejer de potentielle risici.
English: Use your separate ‘reliever inhaler' to treat asthma symptoms when they happen.
Danish: Brug din særskilte inhalator med anfaldsmedicin til at behandle astmasymptomer, når de opstår.
English: Two 12-week paediatric studies have been performed in which 265 children aged 6-11 years were treated with a maintenance dose of budesonide/formoterol (2 inhalations of 80 micrograms/4.5 micrograms /inhalation twice daily), and a short acting β2 adrenoceptor agonist as needed.
Danish: To 12-ugers pædiatriske studier er blevet udført, hvor 265 børn i alderen 6-11 år blev behandlet med en vedligeholdelsesdosis af budesonid/formoterol (2 inhalationer af 80 mikrogram/4,5 mikrogram per inhalation to gange dagligt) og en korttidsvirkende β2-agonist efter behov.
English: Symptoms and signs which might be seen in acute adrenal crisis may be somewhat vague but may include anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, decreased level of consciousness, seizures, hypotension and hypoglycaemia.
Danish: Symptomer og tegn, som eventuelt kan ses ved akut binyrebarkinsufficiens, kan være ret vage, men kan omfatte anoreksi, abdominalsmerter, vægttab, træthed, hovedpine, kvalme, opkastning, nedsat bevidsthedsniveau, krampeanfald, hypotension og hypoglykæmi.
English: Always use this medicine exactly as your doctor or pharmacist has told you.
Danish: Brug altid lægemidlet nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: • you have low levels of potassium in your blood.
Danish: • Du har et lavt indhold af kalium i blodet.
English: These effects happen very rarely and are much less likely to happen with inhaled corticosteroids than with corticosteroid tablets.
Danish: Disse virkninger forekommer meget sjældent og er langt mindre tilbøjelige til at forekomme med inhalerede kortikosteroider end med kortikosteroid-tabletter.
English: • Check the dose indicator to see that there are 120 inhalations in the inhaler.
Danish: • Se i dosisindikatoren for at kontrollere, at der er 120 inhalationer i inhalatoren.
English: Administration of a fixed-dose combination therapy of budesonide and formoterol fumarate dihydrate to women who are breast-feeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.
Danish: Behandling af ammende kvinder med fastdosiskombination af budesonid og formoterolfumaratdihydrat bør kun overvejes, hvis den forventede fordel for moderen er større end en eventuel risiko for barnet.
English: • Check the dose indicator to see that there are 60 inhalations in the inhaler.
Danish: • Se i dosisindikatoren for at kontrollere, at der er 60 inhalationer i inhalatoren.
English: clarithromycin and telithromycin).
Danish: posaconazol, clarithromycin og telithromycin).
English: Close: Breathe out gently and close the mouthpiece cover.
Danish: Lukning: Pust forsigtigt ud og luk mundstykkets låg.
English: • The dose indicator, on the rear of the device, shows the number of inhalations remaining in even numbers only.
Danish: • Dosisindikatoren på bagsiden af enheden viser kun de lige antal resterende inhalationer.
English: Breathe out gently (as far as is comfortable).
Danish: Ånd forsigtigt ud (så længe du kan uden at føle ubehag).
English: Your medicine is actively metered.
Danish: Din medicin afmåles automatisk.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Contains 1 inhaler.
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER Indeholder 1 inhalator.
English: In studies the mean lung deposition of formoterol after inhalation via the powder inhaler ranged from 28% to 49% of the delivered dose.
Danish: I studier lå den gennemsnitlige lungedeponering af formoterol efter inhalation via pulverinhalatoren mellem 28 % og 49 % af den afgivne dosis.
English: Pharmacokinetic parameters for the respective substances were comparable after the administration of budesonide and formoterol as monoproducts or as the fixed-dose combination.
Danish: Farmakokinetiske parametre for de 2 substanser var sammenlignelige efter administration af budesonid og formoterol som enkeltstofpræparater og som fastdosiskombination.
English: Symptoms reported from isolated cases are tachycardia, hyperglycaemia, hypokalaemia, prolonged QTc-interval, arrhythmia, nausea and vomiting.
Danish: Symptomer rapporteret fra isolerede tilfælde er takykardi, hyperglykæmi, hypokaliæmi, forlænget QTc-interval, arytmier, kvalme og opkastning.
English: No increased incidence of adverse reactions has been seen following concurrent administration of the two compounds.
Danish: Der er ikke set øget forekomst af bivirkninger efter samtidig administration af de to stoffer.
English: Budesonide and formoterol have not been observed to interact with any other medicinal products used in the treatment of asthma.
Danish: Det er ikke set, at budesonid og formoterol interagerer med andre lægemidler til behandling af astma.
English: Breathe in forcefully and deeply through the mouthpiece.
Danish: Tag en dyb og kraftig indånding gennem mundstykket.
English: There are no indications of any metabolic interactions or any displacement reactions between formoterol and budesonide.
Danish: Der er ingen tegn på metaboliske interaktioner eller eventuelle fortrængningsreaktioner mellem formoterol og budesonid.
English: The pharmacokinetics of budesonide or formoterol in children and patients with renal failure are unknown.
Danish: Farmakokinetikken af budesonid og formoterol hos børn og patienter med nyresvigt er ukendt.
English: The most common symptoms that may occur after if you use more Budesonide/Formoterol Teva Pharma B.V. than you should are trembling, headache or a rapid heartbeat.
Danish: De hyppigste symptomer, der kan opstå efter, du har taget for meget Budesonid/Formoterol Teva Pharma B.V., er rysten, hovedpine eller hurtig hjerterytme (puls).
English: Use the label on the inhaler to write down the opening date of the foil pouch.
Danish: Brug etiketten på inhalatoren til at skrive, hvornår du åbnede folieposen.
English: If you become wheezy or breathless, or develop any other symptoms of an asthma attack, use your ‘reliever inhaler', then seek medical advice.
Danish: Hvis du får hvæsende vejrtrækning eller bliver forpustet eller udvikler andre symptomer på et astmaanfald, skal du bruge din inhalator med anfaldsmedicin, og derefter søge læge.
English: A randomised, open-label placebo study was performed in children and adolescents with asthma (aged 6-17 years), adults with asthma (aged 18-45 years), and healthy volunteers (aged 18-45 years) to evaluate the peak inspiratory flow rate (PIFR) and other related inhalation parameters following inhalation from a Spiromax device (containing placebo) compared with inhalation from an already marketed multi-dose dry powder inhaler device (containing placebo).
Danish: Et randomiseret, open-label placebo-studie blev foretaget hos børn og unge med astma (i alderen 6-17 år), voksne med astma (i alderen 18-45 år) og raske frivillige (i alderen 18-45 år) for at vurdere den maksimale inspiratoriske flow (PIF) hastighed og andre relaterede inhalationsparametre efter inhalation fra et Spiromax-device (indeholdende placebo) sammenlignet med inhalation fra en allerede markedsført tørpulverinhalator (indeholdende placebo) med flere doser.
English: During transfer from oral therapy to a budesonide/formoterol fumarate fixed-dose combination therapy, a generally lower systemic steroid action will be experienced which may result in the appearance of allergic or arthritic symptoms such as rhinitis, eczema and muscle and joint pain.
Danish: Ved skift fra oral behandling til behandling med en fastdosiskombination af budesonid/formoterolfumarat opleves der generelt en lavere systemisk steroidvirkning, som kan resultere i forekomst af allergiske symptomer eller gigtsymptomer, såsom rhinitis, eksem og muskelog ledsmerter.
English: Animal studies have also identified an involvement of excess prenatal glucocorticoids in increased risks for intrauterine growth retardation, adult cardiovascular disease and permanent changes in glucocorticoid receptor density, neurotransmitter turnover and behaviour at exposures below the teratogenic dose range.
Danish: Dyrestudier har desuden vist, at der er en sammenhæng mellem øget prænatalt glukokortikoidniveau og øget risiko for intrauterin væksthæmning, hjertekarsygdom som voksen og permanente ændringer i tætheden af glukokortikoidreceptorer, neurotransmitter-turnover og adfærd ved eksponeringer under det teratogene dosisområde.
English: The fixed-dose combination of budesonide and formoterol, and the corresponding monoproducts have been shown to be bioequivalent with regard to systemic exposure of budesonide and formoterol, respectively.
Danish: Kombinationspræparat med fast dosis af budesonid og formoterol og de tilsvarende enkeltpræparater er påvist at være bioækvivalente med hensyn til systemisk eksponering af hhv. budesonid og formoterol.
English: • β blockers (such as atenolol or propranolol for high blood pressure or a heart condition), including eyedrops (such as timolol for glaucoma).
Danish: • Betablokkere (såsom atenolol eller propranolol mod for højt blodtryk eller en hjertesygdom), herunder også øjendråber (såsom timolol mod grøn stær).
English: Ask your pharmacist how to throw away medicines you no longer use.
Danish: • Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: • Diuretics, also known as ‘water tablets' (such as furosemide).
Danish: • Diuretika, også betegnet vanddrivende medicin (såsom furosemid).
English: Concomitant treatment of β2 adrenoceptor agonists with medicinal products which can induce hypokalaemia or potentiate a hypokalaemic effect, e.g. xanthine-derivatives, steroids and diuretics, may add to a possible hypokalaemic effect of the β2 adrenoceptor agonist.
Danish: Samtidig behandling med β2-adrenoceptoragonister og lægemidler, som kan inducere hypokaliæmi eller potensere en hypokaliæmisk virkning, f.eks. xanthin-derivater, steroider og diuretika, kan øge risikoen for hypokaliæmisk virkning af β2-agonisten.
English: It is recommended that the dose is tapered when the treatment is discontinued and should not be stopped abruptly.
Danish: Ved behandlingsophør bør dosis nedsættes gradvist; behandlingen bør ikke stoppe pludseligt.
English: There is an elevated risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons.
Danish: Der er en øget risiko for arytmier hos patienter, som samtidigt bliver bedøvet med halogenerede kulbrinter.
English: Date of latest renewal:
Danish: Dato for første markedsføringstilladelse: Dato for seneste fornyelse:
English: Inhaled budesonide is rapidly absorbed and the maximum plasma concentration is reached within 30 minutes after inhalation.
Danish: Budesonid absorberes hurtigt efter inhalation, og maksimal plasmakoncentration opnås inden for 30 minutter efter inhalation.
English: Inhalation powder.
Danish: Inhalationspulver.
English: • Bruising of the skin.
Danish: • Blå mærker på huden.
English: Adults (18 years and older): 1 inhalation twice daily.
Danish: Voksne (fra og med 18 år): 1 inhalation to gange dagligt.
English: • you have problems with your thyroid or adrenal glands.
Danish: • Du har problemer med skjoldbruskkirtlen eller binyrerne.
English: • Phenothiazine medicines (such as chlorpromazine and prochlorperazine).
Danish: • Phenothiaziner (såsom chlorpromazin og prochlorperazin).
English: B.V. contains lactose')
Danish: indeholder lactose')
English: See leaflet for further information
Danish: Se indlægssedlen for yderligere oplysninger.
English: • Medicines for allergies or antihistamines (such as terfenadine).
Danish: • Antihistaminer (lægemidler mod allergi) (såsom terfenadin).
English: Treatment with β2 adrenoceptor agonists may result in an increase in blood levels of insulin, free fatty acids, glycerol and ketone bodies.
Danish: Behandling med β2-agonister kan give anledning til en stigning i blodets indhold af insulin, frie fedtsyrer, glycerol og ketonstoffer.
English: Children and adolescents This medicine should not be used in children or adolescents under the age of 18 years.
Danish: Børn og unge Dette lægemiddel må ikke anvendes til børn eller unge under 18 år.
English: The prophylactic use of Budesonide/Formoterol Teva Pharma B.V., e.g. before exercise, has not been studied.
Danish: Profylaktisk brug af Budesonid/Formoterol Teva Pharma B.V., f.eks. før motion, er ikke blevet undersøgt.
English: The benefits of inhaled budesonide therapy would normally minimise the need for oral steroids, but patients transferring from oral steroids may remain at risk of impaired adrenal reserve for a considerable time.
Danish: Den gavnlige effekt af inhalationsbehandling med budesonid vil normalt minimere behovet for orale steroider, men patienter, der har været i behandling med orale steroider, kan være i risiko for at have nedsat binyrebarkfunktion i længere tid.
English: • Palpitations (awareness of your heart beating), trembling or shaking.
Danish: • Hjertebanken (bevidsthed om, at dit hjerte banker), skælven eller rysten.
English: Paradoxical bronchopasm responds to a rapidacting inhaled bronchodilator and should be treated straightaway.
Danish: Paradoks bronkospasme reagerer på en hurtigtvirkende inhaleret bronkodilator og skal behandles med det samme.
English: Patients with renal or hepatic impairment
Danish: Patienter med nedsat lever- eller nyrefunktion
English: β2 adrenoreceptor agonists
Danish: β2-agonister
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Lactose monohydrate.
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer Lactosemonohydrat.