FrancophonIA/ELRC3.0 huggingface dataset:
English: For changes in lung-function parameters, such as FEV1, budesonide/formoterol was not superior to treatment with formoterol alone.
Danish: Med hensyn til ændringer i lungefunktionsparametre, såsom FEV1, var budesonid/formoterol ikke bedre end behandling med formoterol alene.
English: Hold your breath for 10 seconds or as long as you comfortably can. 6.
Danish: Hold vejret i 10 sekunder eller så længe du kan uden at føle ubehag.
English: • Increased mucus production, change in mucus colour
Danish: • øget slimproduktion, ændring i slimens farve
English: - The other ingredient is lactose monohydrate (see section 2 under ‘Budesonide/Formoterol Teva contains lactose')
Danish: - Øvrige indholdsstoffer: lactosemonohydrat (se punkt 2 under 'Budesonid/Formoterol Teva indeholder lactose')
English: Budesonide/Formoterol Teva pharmacokinetic profile
Danish: Budesonid/Formoterol Teva farmakokinetisk profil
English: The mean number of exacerbations per year (as defined above) was significantly reduced with budesonide/formoterol as compared with treatment with formoterol alone or placebo (mean rate 1.4 compared with 1.8-1.9 in the placebo/formoterol group).
Danish: Det gennemsnitlige antal eksacerbationer om året (som defineret ovenfor) blev reduceret væsentligt med budesonid/formoterol sammenlignet med formoterol alene eller placebo (i gennemsnit 1,4 sammenlignet med 1,8-1,9 i placebo/formoterol-gruppen).
English: The dosage of Budesonide/Formoterol Teva is individual and should be adjusted to the severity of the disease.
Danish: Doseringen af Budesonid/Formoterol Teva er individuel og skal justeres i henhold til sygdommens sværhedsgrad.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.com
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Mild irritation in the throat, coughing, hoarseness Bronchospasm
Danish: Let irritation i halsen, hoste, hæshed Bronkospasme
English: • Fever or chills
Danish: • feber eller kulderystelser
English: How to take an inhalation
Danish: Sådan tager du en inhalation
English: In two 12-month studies, the effect on lung function and the rate of exacerbation (defined as courses of oral steroids and/or course of antibiotics and/or hospitalisations) in patients with severe COPD was evaluated.
Danish: I to 12-måneders studier evalueredes indvirkningen på lungefunktion og hyppigheden af eksacerbationer (defineret som forløb med orale steroider og/eller forløb med antibiotika og/eller indlæggelser) hos patienter med svær KOL.
English: Hypokalaemia Hyperglycaemia
Danish: Hypokaliæmi Hyperglykæmi
English: In a 3-year clinical trial with budesonide in COPD, skin bruises and pneumonia occurred at a frequency of 10% and 6%, respectively, compared with 4% and 3% in the placebo group (p<0.001 and p<0.01, respectively).
Danish: I et 3-årigt klinisk studie med budesonid hos KOL-patienter forekom blå mærker på huden og pneumoni med en hyppighed på henholdsvis 10 % og 6 % sammenlignet med 4 % og 3 % i placebogruppen (p < 0,001 henholdsvis p < 0,01).
English: METHOD OF ADMINISTRATION EXPIRY DATE
Danish: ADMINISTRATIONSMETODE UDLØBSDATO
English: The mean PIFR achieved by patients with asthma or COPD was over 60L/min, a flow rate at which both devices studied are known to deliver comparable amounts of drug to the lungs.
Danish: Den gennemsnitlige PIF-hastighed opnået af patienter med astma eller KOL var over 60 l/min, en flow-hastighed, hvor de 2 undersøgte devices vides at levere en sammenlignelig mængde lægemiddel til lungerne.
English: Clinical studies in adults have shown that the addition of formoterol to budesonide improved asthma symptoms and lung function, and reduced exacerbations.
Danish: Kliniske studier hos voksne har vist, at tillæg af formoterol til budesonid forbedrede astmasymptomer og lungefunktion samt reducerede eksacerbationer.
English: Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations.
Danish: Lægen skal være opmærksom på mulig udvikling af pneumoni hos KOL-patienter, da de kliniske tegn på sådanne infektioner ligner symptomerne på KOL-eksacerbationer.
English: Candida infections in the oropharynx, pneumonia (in COPD patients)
Danish: Candida-infektioner i orofarynx, pneumoni (hos KOL-patienter)
English: Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Ireland Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Netherlands Teva Operations Sp. Z o.o ul, Mogilska 80; 31-546 Krakow, Poland.
Danish: Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Irland Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Holland Teva Operations Sp. Z o.o ul, Mogilska 80, 31-546 Krakow, Polen Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: The mean number of days on oral corticosteroids/patient during the 12 months was slightly reduced in the budesonide/formoterol group (7-8 days/patient/year compared with 11-12 and 9-12 days in the placebo and formoterol groups, respectively).
Danish: Det gennemsnitlige antal dage på oralt kortikosteroid/patient i de 12 måneder blev reduceret en smule i budesonid/formoterolgruppen (7-8 dage/patient/år sammenlignet med 11-12 og 9-12 dage i henholdsvis placebo- og formoterol-grupperne).
English: Budesonide/Formoterol Teva is an inhalation powder.
Danish: Budesonid/Formoterol Teva er et inhalationspulver.
English: Budesonide/Formoterol Teva contains lactose
Danish: Budesonid/Formoterol Teva indeholder lactose
English: • Do not use this medicine after the expiry date which is stated on the carton or on the label of your inhaler after EXP.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på pakningen eller på etiketten til din inhalator efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index (BMI) and severe COPD.
Danish: Risikofaktorer for pneumoni hos KOL-patienter inkluderer aktiv rygning, højere alder, lavt BMI (body mass index) og svær KOL.
English: Patients should be reassessed regularly by their prescriber/healthcare provider so that the dose of Budesonide/Formoterol Teva remains optimal.
Danish: Patienterne bør revurderes med jævne mellemrum af deres læge/sundhedsperson, således at dosis af Budesonid/Formoterol Teva forbliver optimal.
English: The data from the study indicated that regardless of age and underlying disease severity, children, adolescents and adults with asthma as well as patients with COPD were able to able to achieve inspiratory flow rates through the Spiromax device that were similar to those generated through the marketed multi-dose dry powder inhaler device.
Danish: Data fra studiet viste, at uanset alder og sværhedsgrad af den underliggende sygdom, var børn, unge og voksne med astma, såvel som patienter med KOL, i stand til at opnå et inspiratorisk flow gennem Spiromax-devicet, der svarede til det flow, der blev opnået gennem den markedsførte tørpulverinhalator med flere doser.
English: Do not use Budesonide/Formoterol Teva to treat these asthma symptoms.
Danish: Brug ikke Budesonid/Formoterol Teva til at behandle disse astmasymptomer.
English: Your doctor may also prescribe another bronchodilator medicine, for example an anticholinergic (such as tiotropium or ipratropium bromide) for your COPD disease.
Danish: Din læge kan også ordinere en anden bronkodilator-medicin, f.eks. et antikolinergikum (såsom tiotropium eller ipratropiumbromid) for din KOL.
English: An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids.
Danish: Der er set en øget forekomst af pneumoni, herunder pneumoni, der krævede hospitalsindlæggelse, hos KOL-patienter, der fik kortikosteroider til inhalation.
English: Since Budesonide/Formoterol Teva contains both budesonide and formoterol, the same pattern of adverse reactions as reported for these substances may occur.
Danish: Da Budesonid/Formoterol Teva indeholder både budesonid og formoterol, kan det samme bivirkningsmønster, som er indberettet for disse stoffer, forekomme.
English: (budesonide/formoterol fumarate dihydrate)
Danish: (budesonid/formoterolfumaratdihydrat)
English: Budesonide/Formoterol Teva can also be used to treat the symptoms of severe COPD in adults.
Danish: Budesonid/Formoterol Teva kan også anvendes til at behandle symptomer på svær KOL hos voksne.
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: Each dose contains approximately 10 milligrams of lactose (as monohydrate) .
Danish: Hver dosis indeholder cirka 10 milligram lactose (som monohydrat).
English: Each dose contains approximately 5 milligrams of lactose (as monohydrate).
Danish: Hver dosis indeholder cirka 5 milligram lactose (som monohydrat).
English: Budesonide/Formoterol Teva contains formoterol and budesonide, which have different modes of action and show additive effects in terms of reduction of asthma exacerbations.
Danish: Budesonid/Formoterol Teva indeholder formoterol og budesonid, som har forskellige virkningsmekanismer og udviser additiv virkning med hensyn til reduktion af astmaeksacerbationer.
English: If you have been taking steroid tablets for your asthma or COPD, your doctor may reduce the number of tablets that you take, once you start to use Budesonide/Formoterol Teva.
Danish: Hvis du har taget steroidtabletter for din astma eller KOL, kan lægen reducere det antal tabletter, du tager, når du begynder at bruge Budesonid/Formoterol Teva.
English: The most common symptoms that may occur after if you use more Budesonide/Formoterol Teva 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, er rysten, hovedpine eller hurtig hjerterytme (puls).
English: The prophylactic use of Budesonide/Formoterol Teva , e.g. before exercise, has not been studied.
Danish: Profylaktisk brug af Budesonid/Formoterol Teva, f.eks. før motion, er ikke blevet undersøgt.
English: Contains 1 inhaler.
Danish: Indeholder 1 inhalator.
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 to substanser var sammenlignelige efter administration af budesonid og formoterol som enkeltstofpræparater og som fastdosiskombination.
English: Budesonide/Formoterol Teva is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:
Danish: Budesonid/Formoterol Teva er indiceret til behandling af astma, hvor det er hensigtsmæssigt at anvende en kombination (inhaleret kortikosteroid og langtidsvirkende β2-agonist):
English: Patients should not be initiated on Budesonide/Formoterol Teva during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.
Danish: Patienter bør ikke starte behandling med Budesonid/Formoterol Teva under en eksacerbation eller ved signifikant eller akut forværring af astma.
English: Chronic obstructive pulmonary disease (COPD)
Danish: Kronisk obstruktiv lungesygdom (KOL)
English: If the patient experiences paradoxical bronchopasm Budesonide/Formoterol Teva should be discontinued immediately, the patient should be assessed and an alternative therapy instituted, if necessary.
Danish: Hvis patienten oplever paradoks bronkospasme, skal Budesonid/Formoterol Teva straks seponeres, patienten udredes og alternativ behandling iværksættes, hvis det er nødvendigt.
English: Budesonide/Formoterol Teva should be discontinued immediately, the patient should be assessed and an alternative therapy is instituted if necessary (see section 4.4).
Danish: Budesonid/Formoterol Teva skal straks seponeres, patienten skal udredes og alternativ behandling iværksættes, hvis det er nødvendigt (se pkt.
English: You should speak to your doctor if you are concerned as to whether you should continue to use Budesonide/Formoterol Teva.
Danish: Tal med din læge, hvis du er i tvivl om, hvorvidt du skal fortsætte med at bruge Budesonid/Formoterol Teva.
English: There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products.
Danish: Der er ikke fundet afgørende klinisk evidens på forskelle i risikoen for pneumoni mellem de enkelte klasser af kortikosteroider til inhalation.
English: If you are doing exercise and you get asthma symptoms, use your separate ‘reliever inhaler' to relieve these symptoms.
Danish: Hvis du motionerer og får astmasymptomer, skal du bruge din særskilte inhalator med anfaldsmedicin for at lindre disse symptomer.
English: Inhalation powder 1 inhaler containing 60 doses.
Danish: Inhalationspulver 1 inhalator indeholdende 60 doser.
English: Inhalation powder 1 inhaler containing 120 doses.
Danish: Inhalationspulver 1 inhalator indeholdende 120 doser.
English: If Budesonide/Formoterol Teva therapy has to be withdrawn due to overdose of the formoterol component of the medicinal product, provision of appropriate inhaled corticosteroid therapy must be considered.
Danish: Hvis det er nødvendigt at seponere Budesonid/Formoterol Teva på grund af overdosering med lægemidlets formoterol-komponent, skal det overvejes at give passende behandling med inhaleret kortikosteroid.
English: • If you get pregnant while using Budesonide/Formoterol Teva, do NOT stop using Budesonide/Formoterol Teva but talk to your doctor immediately.
Danish: • Hvis du bliver gravid, mens du bruger Budesonid/Formoterol Teva, skal du IKKE holde op med at bruge Budesonid/Formoterol Teva, men straks tale med din læge.
English: Budesonide/Formoterol Teva contains two different active substances: budesonide and formoterol fumarate dihydrate.
Danish: Budesonid/Formoterol Teva indeholder to aktive stoffer: budesonid og formoterolfumaratdihydrat.
English: If you feel you are getting breathless or wheezy while using Budesonide/Formoterol Teva, you should continue to use Budesonide/Formoterol Teva 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, skal du fortsætte med at bruge Budesonid/Formoterol Teva, men søge læge så hurtigt som muligt, da du måske har brug for yderligere behandling.
English: Budesonide/Formoterol Teva is not likely to affect your ability to drive or to use tools or machines.
Danish: Det er ikke sandsynligt, at Budesonid/Formoterol Teva vil påvirke din evne til at køre motorkøretøj eller betjene maskiner.
English: Teva Pharma B.V., Swensweg 5, 2031GA Haarlem,The Netherlands
Danish: Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, Holland
English: If any of the following happen to you, stop using Budesonide/Formoterol Teva and talk to your doctor immediately:
Danish: Hvis noget af følgende sker for dig, skal du holde op med at bruge Budesonid/Formoterol Teva og straks tale med din læge:
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: 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), adults with chronic obstructive pulmonary disease (COPDaged >50 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), voksne med kronisk obstruktiv lungesygdom (KOL - i alderen > 50 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: • Medicines for allergies or antihistamines (such as terfenadine).
Danish: • Antihistaminer (lægemidler mod allergi) såsom terfenadin.
English: The specific properties of budesonide and formoterol allow the combination to be used as maintenance treatment of asthma.
Danish: De specifikke egenskaber af budesonid og formoterol gør, at kombinationen kan anvendes som enten vedligeholdelses- og behovssbehandling eller som vedligeholdelsesbehandling af astma.
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.
Danish: Patienterne skal informeres om at fortsætte behandlingen og søge læge, hvis astmasymptomerne forbliver ukontrollerede eller forværres efter påbegyndelse af Budesonid/Formoterol Teva-behandling.
English: Budesonide/Formoterol Teva has no or negligible influence on the ability to drive and use machines.
Danish: Budesonid/Formoterol Teva påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: If your doctor feels that you need a lower dose than is available from your Budesonide/Formoterol Teva, your doctor may prescribe an alternative inhaler containing the same active substances as your Budesonide/Formoterol Teva 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, kan din læge ordinere en anden inhalator, som indeholder de samme aktive stoffer som Budesonid/Formoterol Teva, men med en lavere dosis kortikosteroid.
English: Budesonide/Formoterol Teva is not an appropriate treatment for the adult patient with only mild asthma who is not adequately controlled with an inhaled corticosteroid and “as needed” inhaled short-acting β2 adrenoreceptor agonists.
Danish: Budesonid/Formoterol Teva er ikke en passende behandling til voksne patienter, som blot lider af mild astma, som ikke kontrolleres tilstrækkeligt med inhalationssteroid samt korttidsvirkende β2-agonist efter behov.
English: Budesonide/Formoterol Teva is taken as regular maintenance treatment with a separate rapid-acting bronchodilator reliever inhaler.
Danish: Budesonid/Formoterol Teva tages regelmæssigt som vedligeholdelsesbehandling med en særskilt hurtigvirkende bronkodilator til anfaldsbrug.
English: • Use Budesonide/Formoterol Teva every day.
Danish: • Brug Budesonid/Formoterol Teva hver dag.
English: Do not use Budesonide/Formoterol Teva just before exercise to stop asthma symptoms from occurring, use your separate ‘reliever inhaler'.
Danish: Du må ikke bruge Budesonid/Formoterol Teva, lige før du skal motionere, for at forhindre astmasymptomerne i at opstå, du skal i stedet bruge din særskilte inhalator med anfaldsmedicin.
English: You are allergic to budesonide, formoterol fumarate dihydrate, or the other ingredient in this medicine (listed in section 6).
Danish: Hvis du er allergisk over for budesonid, formoterolfumaratdihydrat eller det øvrige indholdsstof i Budesonid/Formoterol Teva (angivet i punkt 6).
English: • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor,pharmacist or nurse for advice before taking Budesonide/Formoterol Teva - do NOT use this medicine unless your doctor tells you to.
Danish: • Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge, apotekspersonalet eller sundhedspersonalet til råds, før du tager Budesonid/Formoterol Teva - brug IKKE denne medicin, medmindre din læge beder dig om det.
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.
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.
English: - The active substances are budesonide and formoterol fumarate dihydrate.
Danish: - Aktive stoffer: budesonid og formoterolfumaratdihydrat.
English: A separate rapid-acting bronchodilator should be considered for such prophylactic use.
Danish: Til sådanne situationer bør en separat hurtigtvirkende bronkodilator overvejes.
English: Budesonide/Formoterol Teva is not intended for the initial management of asthma.
Danish: Budesonid/Formoterol Teva er ikke beregnet til indledende behandling af astma.
English: Symptoms include shortness of breath, cough, chest discomfort and coughing up mucus.
Danish: Symptomerne inkluderer åndenød, hoste, ubehag i brystet og ophostning af slim.
English: This medicine should not be used in children or adolescents under the age of 18 years.
Danish: Dette lægemiddel må ikke anvendes til børn eller unge under 18 år.
English: In pharmacokinetic studies with and without a charcoal blockage, Budesonide/Formoterol Teva was evaluated by comparing it with an alternative authorised fixed-dose combination inhaled product containing the same active substances, budesonide and formoterol and has been shown to be equivalent in both systemic exposure (safety) and pulmonary deposition (efficacy).
Danish: I farmakokinetiske studier med og uden blokade med medicinsk kul blev Budesonid/Formoterol Teva evalueret ved at sammenligne det med et andet godkendt inhalationspræparat med fastdosiskombination, der indeholdt de samme aktive indholdsstoffer, budesonid og formoterol.
English: Cushing´s syndrome, adrenal suppression, growth retardation, decrease in bone mineral density
Danish: Cushings syndrom, binyrebarksuppression, væksthæmning, nedsat knogletæthed
English: If you use more Budesonide/Formoterol Teva than you should, contact your doctor, pharmacist or nurse for advice.
Danish: Hvis du har brugt for meget Budesonid/Formoterol Teva, skal du kontakte lægen, apotekspersonalet eller sundhedspersonalet.
English: Cardiac arrhythmias, e.g. atrial fibrillation, supraventricular tachycardia, extrasystoles Angina pectoris.
Danish: Hjertearytmier, f.eks. atrieflimren, supraventrikulær takykardi, ekstrasystoler Angina pectoris, forlænget QTc-interval
English: Variations in blood pressure
Danish: Blodtryksvariationer
English: Pneumonia in patients with COPD
Danish: Pneumoni hos KOL-patienter
English: Use your Budesonide/Formoterol Teva every day.
Danish: Brug Budesonid/Formoterol Teva hver dag.
English: Patients should be reminded to take their Budesonide/Formoterol Teva maintenance dose as prescribed, even when asymptomatic.
Danish: Patienterne bør mindes om at tage deres vedligeholdelsesdosis som ordineret, også når de er symptomfri.
English: Budesonide/Formoterol Teva is not indicated in children and adolescents under the age of 18 years (see section 4.2).
Danish: Budesonid/Formoterol Teva er ikke indiceret hos børn og unge under 18 år (se pkt.