FrancophonIA/ELRC3.0 huggingface dataset:
English: They should be reassessed and their maintenance therapy should be reconsidered.
Danish: De bør revurderes, og deres vedligeholdelsesbehandling bør genovervejes.
English: Headache, tremor
Danish: Hovedpine, tremor
English: • If you do not feel better, take another inhalation.
Danish: • Hvis du ikke får det bedre, skal du tage endnu en inhalation.
English: If symptoms persist after a few minutes, an additional inhalation should be taken.
Danish: Hvis symptomerne fortsætter efter et par minutter, bør der tages yderligere en inhalation.
English: • a slowing of the rate of growth of children and adolescents
Danish: • forsinkelse af væksten hos børn og unge
English: Reduction in exacerbation rate is statistically significant (P value <0.01) for both comparisons
Danish: Reduktion i hyppigheden af eksacerbationer er statistisk signifikant (p < 0,01) for begge sammenligninger
English: They may need to change your treatment.
Danish: Lægen kan være nødt til at ændre din behandling.
English: • asthma exacerbations in the past requiring medical intervention.
Danish: • tidligere astmaeksacerbationer, der krævede medicinsk intervention.
English: Treatment groups
Danish: Behandlingsgrupper
English: Patients were required to be symptomatic despite use of inhaled glucocorticosteroids.
Danish: Patienterne skulle være symptomatiske på trods af brug af inhaleret glukokortikoid.
English: Patients using more than 8 inhalations daily should be strongly recommended to seek medical advice.
Danish: Patienter, der tager mere end 8 inhalationer dagligt, bør kraftigt anbefales at søge læge.
English: • Oxytocin which is given to pregnant women to induce labour.
Danish: • Oxytocin, som gives til gravide kvinder for at sætte fødslen i gang.
English: This should be considered not only when treatment with combination medicinal products is initiated but also when the maintenance dose is adjusted.
Danish: Dette skal ikke blot overvejes, når behandling med kombinationspræparater iværksættes, men også når vedligeholdelsesdosis justeres.
English: For such, a separate rapid-acting bronchodilator should be considered.
Danish: Til sådanne situationer bør en separat hurtigtvirkende bronkodilator overvejes.
English: Prolongation of QTc-interval
Danish: Forlænget QTc-interval
English: Hospitalisation/emergency room treatment or treatment with oral steroids b
Danish: Indlæggelse/behandling på skadestue eller behandling med orale steroider b
English: If the wheezing comes on suddenly after using this medicine stop using it and talk to your doctor immediately (see below).
Danish: Hvis din hvæsen starter pludseligt efter brug af denne medicin, skal du holde op med at bruge den og straks tale med din læge (se nedenfor).
English: • Disturbance of the heart's electrical system which does not cause symptoms (prolongation of the QTc interval).
Danish: • Forstyrrelse i hjertets elektriske system, som ikke giver symptomer (forlængelse af QTc interval)
English: There is no data available on the potential effect of budesonide on fertility.
Danish: Der er ingen tilgængelige data for den eventuelle virkning af budesonid på fertilitet.
English: Do NOT use more than 12 inhalations in total in 24 hours.
Danish: Brug IKKE mere end i alt 12 inhalationer i løbet af 24 timer.
English: 1 inhalation in the morning and 1 inhalation in the evening or
Danish: 1 inhalation om morgenen og 1 inhalation om aftenen eller
English: The use of BiResp Spiromax follows three steps: open, breathe and close which are outlined below.
Danish: Brugen af BiResp Spiromax følger tre trin: åbning, indånding og lukning, som beskrevet nedenfor.
English: Before using your BiResp Spiromax for the first time, you need to prepare it for use as follows:
Danish: Inden du bruger BiResp Spiromax første gang, skal du gøre den klar til brug på følgende måde:
English: Budesonide/formoterol maintenance and reliever therapy provided statistically significant and clinically meaningful reductions in severe exacerbations for all comparisons in all 5 studies.
Danish: Budesonid/formoterol vedligeholdelses- og behovsbehandling gav statistisk signifikante og klinisk betydningsfulde reduktioner i svære eksacerbationer for alle sammenligninger i alle 5 studier.
English: • Steroid tablets that you take by mouth (such as prednisolone).
Danish: • Steroidtabletter, som du tager gennem munden (f.eks. prednisolon).
English: If you regularly need to use 8 or more inhalations a day, make an appointment to see your doctor.
Danish: Hvis du jævnligt har brug for 8 eller flere inhalationer om dagen, skal du aftale et besøg hos din læge.
English: • inadequate asthma control and in frequent need of a reliever inhaler.
Danish: • utilstrækkelig astmakontrol og med hyppig brug for en inhalator ved anfald
English: BiResp Spiromax should be used correctly in order to achieve effective treatment.
Danish: BiResp Spiromax skal anvendes korrekt for at opnå en effektiv behandling.
English: Patients should take 1 additional inhalation as needed in response to symptoms.
Danish: Patienter bør tage 1 ekstra inhalation efter behov ved forekomst af symptomer.
English: The amount of BiResp Spiromax to use and when to use it depends on how it has been prescribed for you.
Danish: Den mængde BiResp Spiromax, du skal bruge, og hvornår du skal bruge den, afhænger af, hvordan den er ordineret til dig.
English: • An increase in the amount of sugar (glucose) in your blood, when you have a blood test.
Danish: • Forhøjet sukker (glucose) i blodet, når du får taget en blodprøve.
English: Some medicines may increase the effects of BiResp Spiromax and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Danish: Nogle lægemidler kan øge virkningen af BiResp Spiromax, og din læge vil overvåge dig omhyggeligt, hvis du tager sådanne lægemidler (inklusive visse former for HIV-medicin, herunder ritonavir og cobicistat).
English: 2 inhalations in the evening.
Danish: 2 inhalationer om aftenen.
English: • If you are using BiResp Spiromax for asthma, your doctor will want to regularly check your symptoms.
Danish: • Hvis du bruger BiResp Spiromax mod astma, vil din læge ønske at kontrollere dine symptomer med jævne mellemrum.
English: A total daily dose of more than 8 inhalations is not normally needed; however, a total daily dose of up to 12 inhalations could be used for a limited period.
Danish: En samlet daglig dosis på mere end 8 inhalationer er normalt ikke nødvendig, men en samlet daglig dosis på op til 12 inhalationer kan anvendes i et begrænset tidsrum.
English: In the 5 studies combined, patients receiving budesonide/formoterol maintenance and reliever therapy used, on average, no reliever inhalations on 57% of treatment days.
Danish: I de 5 studier samlet set brugte patienter, der fik budesonid/formoterol vedligeholdelses- og behovsbehandling, i gennemsnit ingen inhalationer efter behov i 57 % af behandlingsdagene.
English: Your medicine is actively metered.
Danish: Din medicin måles løbende.
English: Use the label on the inhaler to write down the date you open the foil pouch.
Danish: Brug etiketten på inhalatoren til at skrive den dato, du åbnede folieposen på.
English: You do not need a separate ‘reliever inhaler' for this.
Danish: Du behøver ikke en særskilt inhalator ”inhalator med anfaldsmedicin” hertil.
English: The prophylactic use of BiResp Spiromax, e.g. before exercise, has not been studied.
Danish: Profylaktisk brug af BiResp Spiromax, f.eks. før motion, er ikke blevet undersøgt.
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, især hvis du bruger høje doser i lang tid.
English: Your doctor may consider adding steroid tablets to your usual treatment if you have an illness such as a chest infection or before an operation.
Danish: Din læge kan overveje at føje steroidtabletter til din sædvanlige behandling, hvis du har en sygdom såsom en infektion i brystet eller før en operation.
English: There are no special dosing requirements for elderly patients.
Danish: Speciel dosering er ikke nødvendigt til ældre patienter.
English: Overview of severe exacerbations in clinical studies
Danish: Oversigt over svære eksacerbationer i kliniske studier Studienr.
English: - The other ingredient is lactose monohydrate (see section 2 under ‘BiResp Spiromax contains lactose')
Danish: - Øvrige indholdsstoffer: lactosemonohydrat (se punkt 2 under 'BiResp Spiromax indeholder lactose')
English: • It is important to use BiResp Spiromax every day, even if you have no asthma or COPD symptoms at the time.
Danish: • Det er vigtigt, at du bruger BiResp Spiromax hver dag, også selvom du ikke har nogen astma eller KOL-symptomer på det pågældende tidspunkt.
English: In 2 other studies with patients seeking medical attention due to acute asthma symptoms, budesonide/formoterol provided rapid and effective relief of bronchoconstriction similar to salbutamol and formoterol.
Danish: I 2 andre studier med patienter, der søgte læge på grund af akutte astmasymptomer, gav budesonid/formoterol hurtig og effektiv lindring af bronkokonstriktion svarende til salbutamol og formoterol.
English: If these effects occur, they are usually mild and usually disappear as you continue to use BiResp Spiromax.
Danish: Hvis disse virkninger forekommer, er de som regel lette og forsvinder normalt, når du fortsætter med at bruge BiResp Spiromax.
English: The reliever inhalations of BiResp Spiromax should be taken in response to symptoms but are not intended for regular prophylactic use, e.g. before exercise.
Danish: Inhalation af BiResp Spiromax efter behov bør ske i forbindelse med symptomer, men er ikke beregnet til regelmæssig profylaktisk brug, f.eks. før motion.
English: The dosage of BiResp Spiromax is individual and should be adjusted to the severity of the disease.
Danish: Doseringen af BiResp Spiromax er individuel og skal justeres i henhold til sygdommens sværhedsgrad.
English: The drug/mucosal contact parts of the inhaler are made of acrylonitrile butadiene styrene (ABS), polyethylene (PE), and polypropylene (PP).
Danish: Lægemidlet/de dele af inhalatoren, der får mukosal kontakt er fremstillet af acrylonitril-butadien-styren (ABS), polyethylen (PE) og polypropylen (PP).
English: • Sudden, unexpected and acute wheezing and/or shortness of breath immediately after using your inhaler (also referred to as ‘paradoxical bronchospasm'.
Danish: • Pludselig, uventet og akut hvæsen og/eller åndenød umiddelbart efter, at du har brugt inhalatoren (betegnes også ”paradoks bronkospasme”).
English: 2 inhalations in the morning or
Danish: 2 inhalationer om morgenen eller
English: The specific properties of budesonide and formoterol allow the combination to be used either as maintenance and reliever therapy, or 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: Also tell your doctor, pharmacist or nurse if you are going to have a general anaesthetic for an operation or for dental work to help lower any risk of interaction with the anesthetic you receive.
Danish: Fortæl også lægen, apotekspersonalet eller sundhedspersonalet, hvis du skal bedøves i forbindelse med operation eller tandbehandling, for at hjælpe med at nedsætte risikoen for at påvirke det bedøvelsesmiddel, du får.
English: • Do NOT take more than 6 inhalations at a single time.
Danish: • Tag IKKE mere end 6 inhalationer i én omgang.
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 BiResp Spiromax - 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 BiResp Spiromax - brug IKKE denne medicin, medmindre din læge beder dig om det.
English: However, your doctor may allow you to take up to 12 inhalations a day for a limited period.
Danish: Din læge kan imidlertid give dig lov til at tage op til 12 inhalationer om dagen i et begrænset tidsrum.
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 BiResp Spiromax.
Danish: Hvis du har taget steroidtabletter for din astma eller KOL, kan lægen reducere det antal tabletter, du tager, når du begynder at bruge BiResp Spiromax.
English: If you are doing exercise and you get asthma symptoms, use BiResp Spiromax as described here.
Danish: Hvis du dyrker motion, og du får astmasymptomer, skal du bruge BiResp Spiromax som beskrevet her.
English: A total daily dose of more than 8 inhalations is not normally needed.
Danish: Der er normalt ikke behov for en total daglig dosis på mere end 8 inhalationer.
English: This included a comparison with budesonide/formoterol at a higher maintenance dose with terbutaline as reliever (study 735) and budesonide/formoterol at the same maintenance dose with either formoterol or terbutaline as reliever (study 734) (see table below).
Danish: Dette omfattede en sammenligning med budesonid/formoterol ved en højere vedligeholdelsesdosis med terbutalin efter behov (studie 735) og budesonid/formoterol ved samme vedligeholdelsesdosis med enten formoterol eller terbutalin efter behov (studie 734) (se nedenstående tabel).
English: N Severe exacerbationsa Events Events/ patient-year
Danish: Hændelser/ patient-år
English: You should speak to your doctor if you are concerned as to whether you should continue to use BiResp Spiromax.
Danish: Tal med din læge, hvis du er i tvivl om, hvorvidt du skal fortsætte med at bruge BiResp Spiromax.
English: Concomitant treatment with quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine) 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) og tricykliske antidepressiva kan forlænge QTc-intervallet og øge risikoen for ventrikulære arytmier.
English: Your doctor will help you to manage your asthma and will adjust the dose of this medicine to the lowest dose that controls your asthma.
Danish: Din læge vil hjælpe dig med at behandle din astma og vil justere dosen af dette lægemiddel til den laveste dosis, der kan kontrollere din astma.
English: For BiResp Spiromax there are two treatment approaches:
Danish: For BiResp Spiromax findes der to behandlingsmetoder:
English: Since BiResp Spiromax contains both budesonide and formoterol, the same pattern of adverse reactions as reported for these substances may occur.
Danish: Da BiResp Spiromax indeholder både budesonid og formoterol, kan det samme bivirkningsmønster, som er indberettet for disse stoffer, forekomme.
English: BiResp Spiromax maintenance and reliever therapy should especially be considered for patients with:
Danish: BiResp Spiromax vedligeholdelses- og behovsbehandling bør specielt overvejes til patienter med:
English: A total of 12076 asthma patients were included in 5 double-blind clinical studies (4447 were randomised to budesonide/formoterol maintenance and reliever therapy) for 6 or 12 months.
Danish: I alt 12.076 astmapatienter blev inkluderet i 5 dobbeltblindede kliniske studier (4.447 blev randomiseret til budesonid/formoterol vedligeholdelses- og behovsbehandling) i 6 eller 12 måneder.
English: In Study 735, lung function, symptom control, and reliever use were similar in all treatment groups.
Danish: I studie 735 var resultaterne for lungefunktion, symptomkontrol og brug af anfaldsmedicin sammenlignelige i alle behandlingsgrupper.
English: Variations in blood pressure
Danish: • Ændringer i blodtrykket
English: Patients should be reassessed regularly by their prescriber/healthcare provider so that the dose of BiResp Spiromax remains optimal.
Danish: Patienterne bør revurderes med jævne mellemrum af deres læge/sundhedsperson, således at dosis af BiResp Spiromax forbliver optimal.
English: In Study 734, symptoms and reliever use were reduced and lung function improved, compared with both comparator treatments.
Danish: I studie 734 var symptomer og brug af anfaldsmedicin reduceret og lungefunktion forbedret sammenlignet med begge komparatorbehandlingerne.
English: 1 inhalation twice daily
Danish: 1 inhalation to gange dagligt.
English: Close monitoring for dose-related adverse reactions is needed in patients who frequently take high numbers of BiResp Spiromax as-needed inhalations.
Danish: Nøje overvågning for dosisrelaterede bivirkninger er nødvendig hos patienter, der ofte tager et stort antal BiResp Spiromax inhalationer efter behov.
English: The most common symptoms that may occur after when you use more BiResp Spiromax than you should are trembling, headache or a rapid heartbeat.
Danish: De hyppigste symptomer, der kan opstå efter, du har taget for meget BiResp Spiromax, er rysten, hovedpine eller hurtig hjerterytme (puls).
English: BiResp Spiromax can also be used to treat the symptoms of severe COPD in adults.
Danish: BiResp Spiromax kan også anvendes til at behandle symptomer på svær KOL hos voksne.
English: Pack sizes of 1, 2 or 3 inhalers.
Danish: Multipakninger med 1, 2 eller 3 inhalatorer.
English: If you feel you are getting breathless or wheezy while using BiResp Spiromax, you should continue to use BiResp Spiromax 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 BiResp Spiromax, skal du fortsætte med at bruge BiResp Spiromax, men søge læge så hurtigt som muligt, da du måske har brug for yderligere behandling.
English: <1/10), uncommon (≥1/1,000, < 1/100), rare (≥1/10,000, < 1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Adults (18 years and older): The recommended maintenance dose is 2 inhalations per day, given either as one inhalation in the morning and evening or as 2 inhalations in either the morning or evening.
Danish: Voksne (fra og med 18 år): Den anbefalede vedligeholdelsesdosis er 2 inhalationer dagligt, givet enten som én inhalation morgen og aften eller som 2 inhalationer enten morgen eller aften.
English: BiResp Spiromax contains two different active substances: budesonide and formoterol fumarate dihydrate.
Danish: BiResp Spiromax indeholder to aktive stoffer: budesonid og formoterolfumaratdihydrat.
English: BiResp Spiromax should be discontinued immediately, the patient should be assessed and an alternative therapy is instituted if necessary (see section
Danish: BiResp Spiromax skal straks seponeres, patienten skal udredes og alternativ behandling iværksættes, hvis det er nødvendigt (se pkt.
English: COPD is a long-term lung disease of the airways in the lungs, which is often caused by cigarette smoking.
Danish: KOL er en langvarig sygdom i lungerne, der ofte opstår som følge af cigaretrygning.
English: BiResp Spiromax can be prescribed for asthma in two different ways.
Danish: BiResp Spiromax kan ordineres for astma på to måder.
English: Symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV1) < 70% predicted normal (post bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
Danish: Symptomatisk behandling af patienter med KOL med et forceret ekspiratorisk volumen på 1 sekund (FEV1) < 70 % af forventet normalværdi (post-bronkodilator) og tidligere gentagne eksacerbationer, som har betydelige symptomer på trods af behandling med langtidsvirkende bronkodilator.
English: Patients should be advised to have their rescue inhaler available at all times, either BiResp Spiromax (for asthma patients using BiResp Spiromax as maintenance and reliever therapy) or a separate rapid-acting bronchodilator (for asthma patients using BiResp Spiromax as maintenance therapy only).
Danish: Patienterne skal informeres om altid at have deres anfaldsmedicin på sig, enten BiResp Spiromax (til astmapatienter, der bruger BiResp Spiromax som vedligeholdelses- og behovsbehandling) eller en separat hurtigtvirkende bronkodilator (til astmapatienter, der kun bruger BiResp Spiromax som vedligeholdelsesbehandling).
English: If your doctor feels that you need a lower dose than is available from your BiResp Spiromax, your doctor may prescribe an alternative inhaler containing the same active substances as your BiResp Spiromax 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 BiResp Spiromax, kan din læge ordinere en anden inhalator, som indeholder de samme aktive stoffer som BiResp Spiromax, men med en lavere dosis kortikosteroid.
English: Always keep your BiResp Spiromax with you and use it to relieve sudden attacks of breathlessness and wheezing.
Danish: Hav altid din BiResp Spiromax på dig og brug den til at afhjælpe pludselige anfald af åndenød og hvæsen.
English: The need for, and dose of inhaled corticosteroids should be re-evaluated in patients with active or quiescent pulmonary tuberculosis, fungal and viral infections in the airways.
Danish: Behovet for, og dosis af inhaleret kortikosteroid bør revurderes hos patienter med aktiv eller latent lungetuberkulose eller svampe- og virusinfektioner i luftvejene.
English: Do not use BiResp Spiromax to treat these asthma symptoms.
Danish: Brug ikke BiResp Spiromax til at behandle disse astmasymptomer.
English: • changes in bone mineral density (thinning of the bones)
Danish: • ændringer i knoglemineraltæthed (udtynding af knoglerne)
English: Long-term studies with inhaled budesonide in children at mean daily doses of 400 micrograms (metered dose) or in adults at daily doses of 800 micrograms (metered dose) have not shown any significant effects on bone mineral density.
Danish: Langstidsstudier med inhaleret budesonid hos børn ved gennemsnitlige daglige doser på 400 mikrogram (afmålt dosis) eller hos voksne ved daglige doser på 800 mikrogram (afmålt dosis) har ikke vist nogen signifikante påvirkninger af knoglemineraltætheden.
English: BiResp Spiromax is an inhalation powder.
Danish: BiResp Spiromax er et inhalationspulver.
English: If BiResp Spiromax 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 BiResp Spiromax på grund af overdosering med lægemidlets formoterol-komponent, skal det overvejes at give passende behandling med inhaleret kortikosteroid.
English: Adults (18 years and older):
Danish: Voksne (fra og med 18 år):
English: • If you have been prescribed BiResp Spiromax as your only inhaler, read the section called (B) Using
Danish: • Hvis du har fået ordineret BiResp Spiromax som din eneste inhalator, skal du læse afsnittet (B)
English: 7.Then breathe out gently (do not breathe out through the inhaler).
Danish: Ånd forsigtigt ud (ånd ikke ud gennem inhalatoren).
English: Adverse reactions, which have been associated with budesonide or formoterol, are given below and listed by system organ class and frequency.
Danish: Tabel over bivirkninger Bivirkninger, som har været forbundet med budesonid eller formoterol, er angivet nedenfor og opført efter systemorganklasse og hyppighed.
English: If any of the following happen to you, stop using BiResp Spiromax and talk to your doctor immediately:
Danish: Hvis noget af følgende sker for dig, skal du holde op med at bruge BiResp Spiromax og straks tale med din læge:
English: However, at therapeutic doses no effects on the suckling child are anticipated.
Danish: Der forventes imidlertid ikke nogen indvirkning på det ammende barn ved terapeutiske doser.