FrancophonIA/ELRC3.0 huggingface dataset:
English: • Use BiResp Spiromax when you need to take extra inhalations or puffs to relieve asthma symptoms andto make it easier to breathe again.
Danish: • Brug også BiResp Spiromax, når du har brug for ekstra inhalationer eller pust til lindring af astmasymptomer og for at gøre det lettere at trække vejret igen.
English: If any of the above applies to you, or if you are not sure, talk to your doctor, pharmacist or nurse before using BiResp Spiromax.
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 BiResp Spiromax.
English: If the patient experiences paradoxical bronchopasm BiResp Spiromax should be discontinued immediately, the patient should be assessed and an alternative therapy instituted, if necessary.
Danish: Hvis patienten oplever paradoks bronkospasme, skal BiResp Spiromax straks seponeres, patienten udredes og alternativ behandling iværksættes, hvis det er nødvendigt.
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: This helps to prevent asthma symptoms such as breathlessness and wheezing from occurring.
Danish: Dette hjælper med at forebygge astmasymptomer, såsom åndenød og hvæsen.
English: Study 6 months
Danish: Studie 735 6 måneder
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 flowhastighed hvor de 2 undersøgte devices vides at levere en sammenlignelig mængde lægemiddel til lungerne.
English: Packs of 1, 2, and 3 inhalers.
Danish: Pakker med 1, 2 og 3 inhalatorer.
English: Patients take a daily maintenance dose of BiResp Spiromax and in addition take BiResp Spiromax as needed in response to symptoms.
Danish: Patienterne tager en daglig vedligeholdelsesdosis af BiResp Spiromax og tager desuden BiResp Spiromax efter behov ved forekomst af symptomer.
English: BiResp Spiromax contains formoterol and budesonide, which have different modes of action and show additive effects in terms of reduction of asthma exacerbations.
Danish: BiResp Spiromax indeholder formoterol og budesonid, som har forskellige virkningsmekanismer og udviser additiv virkning med hensyn til reduktion af astmaeksacerbationer.
English: A lower strength of BiResp Spiromax is available for the maintenance and reliever therapy regimen.
Danish: En lavere styrke af BiResp Spiromax er tilgængelig til vedligeholdelses- og behovsbehandling.
English: BiResp Spiromax pharmacokinetic profile
Danish: BiResp Spiromax farmakokinetisk profil
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: BiResp Spiromax has no or negligible influence on the ability to drive and use machines.
Danish: BiResp Spiromax påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: • If you get pregnant while using BiResp Spiromax, do NOT stop using BiResp Spiromax but talk to your doctor immediately.
Danish: • Hvis du bliver gravid, mens du bruger BiResp Spiromax, skal du IKKE holde op med BiResp Spiromax, men straks tale med din læge.
English: • If you get asthma symptoms such as sudden attacks of breathlessness and wheezing, take 1 inhalation and wait a few minutes.
Danish: • Hvis du får astmasymptomer, såsom pludselige anfald af åndenød og hvæsen, skal du tage 1
English: Talk to your doctor,pharmacist or nurse before taking BiResp Spiromax if
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger BiResp Spiromax, hvis
English: The spaces between the even numbers represent the odd number of remaining inhalations.
Danish: Mellemrummene mellem de lige numre viser de ulige antal resterende inhalationer.
English: BiResp Spiromax contains lactose
Danish: BiResp Spiromax indeholder lactose
English: BiResp Spiromax is not likely to affect your ability to drive or to use tools or machines.
Danish: Det er ikke sandsynligt, at BiResp Spiromax vil påvirke din evne til at køre motorkøretøj eller betjene maskiner.
English: BiResp Spiromax is not intended for the initial management of asthma.
Danish: BiResp Spiromax er ikke beregnet til indledende behandling af astma.
English: • glaucoma (increased pressure in the eye)
Danish: • grøn stær (glaukom − øget tryk i øjet)
English: Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation with BiResp Spiromax.
Danish: Patienterne skal informeres om at fortsætte behandlingen og søge læge, hvis astmasymptomerne forbliver ukontrollerede eller forværres efter påbegyndelse af BiResp Spiromaxbehandling.
English: • Open the foil pouch by tearing at the notch at the top of the foil pouch and take out the inhaler
Danish: • Åbn folieposen ved at afrive den øverste del af folieposen og tage inhalatoren ud.
English: • Do not store above 25 oC. Keep the mouthpiece cover closed after removal of the foil wrapping.
Danish: • Må ikke opbevares ved temperaturer over 25 oC. Hold mundstykkets låg lukket, når inhalatoren er taget ud af folien.
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 BiResp Spiromax (angivet i punkt 6).
English: a) You may be prescribed two asthma inhalers: BiResp Spiromax together with a separate ‘reliever inhaler' such as salbutamol.
Danish: a) Du kan få ordineret to astma-inhalatorer: BiResp Spiromax sammen med en separat inhalator med anfaldsmedicin, såsom salbutamol.
English: Patients should be reminded to take their BiResp Spiromax maintenance dose as prescribed, even when asymptomatic.
Danish: Patienterne bør mindes om at tage deres BiResp Spiromax vedligeholdelsesdosis som ordineret, også når de er symptomfri.
English: Limited data about this interaction for high-dose inhaled budesonide indicates that marked increases in plasma levels (on average four fold) may occur if itraconazole, 200 mg once daily, is administered concomitantly with inhaled budesonide (single dose of 1000 micrograms).
Danish: Begrænsede data om denne interaktion for højdosis inhaleret budesonid indikerer, at der kan opstå markant stigning i plasmaniveauet (i gennemsnit fire gange), hvis itraconazol, 200 mg én gang dagligt, gives samtidig med inhaleret budesonid (enkelt dosis på 1000 mikrogram).
English: • Use BiResp Spiromax every day.
Danish: • Brug BiResp Spiromax hver dag.
English: There are no clinical study data on BiResp Spiromax available in COPD patients with a pre-bronchodilator FEV1 >50% predicted normal and with a post-bronchodilator FEV1 <70% predicted normal (see section 5.1)
Danish: Der er ingen tilgængelige kliniske studiedata for BiResp Spiromax for patienter med KOL med en præ-bronkodilator FEV1 på > 50 % af forventet normalværdi, og med en post-bronkodilator FEV1 på < 70 % af forventet normalværdi (se pkt.
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 bronkodilatormedicin, f.eks. et antikolinergikum (såsom tiotropium eller ipratropiumbromid) for din KOL.
English: Patients should be advised to always have BiResp Spiromax available for rescue use.
Danish: Patienterne skal informeres om altid at have BiResp Spiromax tilgængelig til brug ved anfald.
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 oralt administreret budesonid (enkeltdosis 3 mg) seks gange.
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 sværhedsgraden 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: For some patients a maintenance dose of 2 inhalations twice daily may be appropriate.
Danish: For nogle patienter kan en vedligeholdelsesdosis på 2 inhalationer to gange dagligt være hensigtsmæssig.
English: When it is appropriate to titrate down to a lower strength than is available for BiResp Spiromax, 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 BiResp Spiromax, er det nødvendigt at skifte til en alternativ fastdosiskombination af budesonid og formoterolfumarat, som indeholder en lavere dosis af inhaleret kortikosteroid.
English: However, do not use BiResp Spiromax just before exercise to stop asthma symptoms from happening.
Danish: Du må imidlertid ikke bruge BiResp Spiromax lige før, du dyrker motion, for at forhindre, at der opstår astmasymptomer.
English: When used for asthma, your doctor will prescribe BiResp Spiromax together with a separate ‘reliever inhaler' such as salbutamol.
Danish: Ved brug til astma vil din læge ordinere BiResp Spiromax sammen med en separat inhalator med anfaldsmedicin, såsom salbutamol.
English: The safety and efficacy of BiResp Spiromax in children, 12 years and younger and adolescents, 13 to 17 years of age has not yet been established.
Danish: BiResp Spiromax' sikkerhed og virkning hos børn i alderen 12 år og derunder og unge i alderen 13-17 år er endnu ikke klarlagt.
English: Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of BiResp Spiromax.
Danish: Når din astma er velkontrolleret, kan din læge finde det hensigtsmæssigt gradvist at reducere BiResp Spiromax-dosen.
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 prænatal glukokortikoidniveau og øget risiko for intrauterin væksthæmning, hjertekarsygdom som voken og permanente ændringer i tætheden af glukokortikoidreceptorer, neurotransmitter- turnover og adfærd ved eksponeringer under det teratogene dosisområde.
English: The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.
Danish: Kombination bør undgås, medmindre fordelen opvejer den øgede risiko for systemiske kortikosteroid-bivirkninger.
English: BiResp Spiromax maintenance therapy: BiResp Spiromax is taken as regular maintenance treatment with a separate rapid-acting bronchodilator reliever inhaler.
Danish: BiResp Spiromax vedligeholdelsesbehandling: BiResp Spiromax tages regelmæssigt som vedligeholdelsesbehandling med en særskilt hurtigtvirkende bronkodilator til anfaldsbrug.
English: • Medicines for a fast or uneven heartbeat (such as quinidine, disopyramide, procinamide and terfanidine).
Danish: • Lægemidler til behandling af hurtig eller uregelmæssig hjerterytme (såsom quinidin, disopyramid, procainamid og terfenadin).
English: Systemic effects
Danish: Systemiske påvirkninger.
English: • Antipsychotic phenothiazine medicines (such as chlorpromazine and prochlorperazine).
Danish: • Antipsykotiske phenothiaziner (såsom chlorpromazin og prochlorperazin).
English: BiResp Spiromax is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:
Danish: BiResp Spiromax er indiceret til behandling af astma, hvor det er hensigtsmæssigt at anvende en kombination (inhaleret kortikosteroid og langtidsvirkende β2-agonist):
English: BiResp Spiromax maintenance and reliever therapy: BiResp Spiromax is taken as regular maintenance treatment and as needed in response to symptoms.
Danish: BiResp Spiromax vedligeholdelses- og behovsbehandling: BiResp Spiromax tages regelmæssigt som vedligeholdelsesbehandling og efter behov ved symptomer.
English: Chronic Obstructive Pulmonary Disease (COPD)
Danish: Kronisk obstruktiv lungesygdom (KOL)
English: In pharmacokinetic studies with and without a charcoal blockage, BiResp Spiromax 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 BiResp Spiromax evalueret ved at sammenligne det med et andet godkendt inhalationspræparat med fastdosiskombination, der indeholdt de samme aktive indholdsstoffer, budesonid og formoterol.
English: Contents of the pack and other information What BiResp Spiromax contains
Danish: Pakningsstørrelser og yderligere oplysninger BiResp Spiromax indeholder:
English: Use your BiResp Spiromax every day.
Danish: Brug BiResp Spiromax hver dag.
English: BiResp Spiromax 320 micrograms/9 micrograms should be used as maintenance therapy only.
Danish: BiResp Spiromax 320 mikrogram/9,0 mikrogram bør kun anvendes som vedligeholdelsesbehandling.
English: Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of BiResp Spiromax.
Danish: Når astmasymptomerne er under kontrol, kan det overvejes gradvist at reducere dosis af BiResp Spiromax.
English: If you use more BiResp Spiromax than you should, contact your doctor, pharmacist or nurse for advice.
Danish: Hvis du har brugt for meget BiResp Spiromax, skal du kontakte lægen, apotekspersonalet eller sundhedspersonalet.
English: Patients should not be initiated on BiResp Spiromax during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.
Danish: Patienter bør ikke starte behandling BiResp Spiromax under en eksacerbation eller ved signifikant eller akut forværring af astma.
English: Only use BiResp Spiromax in this way if your doctor has told you to. Use your BiResp Spiromax every day.
Danish: Brug kun BiResp Spiromax på denne måde, hvis lægen har bedt dig om det.
English: µg bd + terbutaline 0.4 mg as needed Salmeterol/fluticasone 2 x 25/125 µg bd + terbutaline 0.4 mg as needed
Danish: Budesonid/formoterolfurmaratdihydrat 320/9 µg to gange dagligt + terbutalin 0,4 mg efter behov Salmeterol/fluticason 2 x 25/125 µg to gange dagligt + terbutalin 0,4 mg efter behov
English: • The dose indicator, on the rear of the device, shows the number of inhalations remaining as even numbers.
Danish: • Dosisindikatoren på bagsiden af enheden viser de lige antal resterende inhalationer.
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 glukokortikoid-virkninger, såsom hyperkorticisme og binyrebarksuppression.
English: Each BiResp Spiromax inhaler contains 60 inhalations and has a white body with a semi-transparent wine red mouthpiece cover.
Danish: Hver BiResp Spiromax inhalator indeholder 60 inhalationer og har en hvid hoveddel med et halvgennemsigtigt vinrødt låg til mundstykket.
English: Animal reproduction studies with formoterol have shown a somewhat reduced fertility in male rats at high systemic exposure (see section 5.3).
Danish: Dyrereproduktionsstudier med formoterol har vist en noget nedsat fertilitet hos hanrotter ved høj systemisk eksponering (se pkt.
English: • Do not store above 25oC.
Danish: Må ikke opbevares ved temperaturer over 25 ºC.
English: Each BiResp Spiromax inhaler contains 120 inhalations and has a white body with a semi-transparent wine red mouthpiece cover.
Danish: Hver BiResp Spiromax inhalator indeholder 120 inhalationer og har en hvid hoveddel med et halvgennemsigtigt, vinrødt låg til mundstykket.
English: Linearity/non-linearity Systemic exposure for both budesonide and formoterol correlates in a linear fashion to administered dose.
Danish: Systemisk eksponering over for både budesonid og formoterol korrelerer lineært med den administrerede dosis.
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
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: BiResp Spiromax 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: BiResp Spiromax 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: What you need to know before you use BiResp Spiromax Do not use BiResp Spiromax if:
Danish: Det skal du vide, før du begynder at bruge BiResp Spiromax Brug ikke BiResp Spiromax
English: BiResp Spiromax is NOT indicated for use in children 12 years of age and younger or adolescents 13 to 17 years of age.
Danish: BiResp Spiromax er IKKE beregnet til brug hos børn under 12 år eller unge i alderen 13 til 17 år.
English: If you stop using BiResp Spiromax
Danish: Hvis du holder op med at bruge BiResp Spiromax
English: If you forget to use BiResp Spiromax
Danish: Hvis du har glemt at bruge BiResp Spiromax
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: BiResp Spiromax is indicated for use in adults 18 years of age and older only.
Danish: BiResp Spiromax er udelukkende beregnet til brug hos voksne i alderen 18 år og derover.
English: Adults (18 years and older): • 1 inhalation twice a day, taken in the morning and in the evening.
Danish: Voksne (fra og med 18 år): • 1 inhalation 2 gange dagligt, som tages om morgenen og om aftenen.
English: In animal studies glucocorticosteroids have been shown to induce malformations (see section 5.3).
Danish: Det er i dyrestudier blevet påvist, at glukokortikoider fremkalder misdannelser (se pkt.
English: 1 or 2 inhalations (actuations), twice a day, taken in the morning and in the evening.
Danish: 1 eller 2 inhalationer 2 gange dagligt, som tages om morgenen og om aftenen.
English: Also use BiResp Spiromax as a ‘reliever inhaler' to treat asthma symptoms when they occur.
Danish: Brug også BiResp Spiromax som anfaldsmedicin til behandling af astmasymptomer, når de forekommer.
English: b) You may be prescribed BiResp Spiromax as your only asthma inhaler.
Danish: b) Du kan få ordineret BiResp Spiromax som din eneste astma-inhalator.
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: Symptoms of adrenal gland suppression could be tiredness, weakness, stomach problems including nausea, vomiting, pain and diarrhoea,
Danish: Symptomer på binyreundertrykkelse kan være træthed, svaghed, maveproblemer, herunder kvalme, opkastning,
English: Not more than 6 inhalations should be taken on any single occasion.
Danish: Der må højst tages 6 inhalationer på én gang.
English: • The dose indicator tells you how many doses (inhalations) are left in your inhaler, starting with 120 inhalations when it is full and ending with 0 (zero) inhalations when it is empty.
Danish: Indikatoren starter med 120 inhalationer, når den er fuld, og slutter med 0 (nul) inhalationer, når den er tom.
English: • an effect on the adrenal gland (a small gland next to the kidney).
Danish: • påvirkning af binyrerne (2 små kirtler, der sidder ved nyrerne).
English: • Xanthine medicines (such as theophylline or aminophylline).
Danish: • Lægemidler, der indeholder xanthin (såsom theophyllin eller theophyllinethylendiamin).
English: Other medicines and BiResp Spiromax
Danish: Brug af anden medicin sammen med BiResp Spiromax
English: Budesonide/Formoterol Furmarate Dihydrate 160/4.5 µg bd + as needed
Danish: Budesonid/formoterolfurmaratdihydrat 160/4,5 µg to gange dagligt + efter behov
English: BiResp Spiromax is indicated in adults 18 years of age and older only.
Danish: BiResp Spiromax er indiceret til voksne fra og med 18 år.
English: (B) Using BiResp Spiromax as your only asthma inhaler
Danish: (B) Brug af BiResp Spiromax som din eneste astmainhalator
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 en kombinationsbehandling med budesonid/formoterolfumarat med fast dosis.
English: • The dose indicator tells you how many doses (inhalations) are left in your inhaler, starting with 60 inhalations when it is full and ending with 0 (zero) inhalations when it is empty.
Danish: Indikatoren starter med 60 inhalationer, når den er fuld, og slutter med 0 (nul) inhalationer, når den er tom.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Front panel: Not for use in children and adolescents.
Danish: Karton-forside: Må ikke anvendes til børn og unge.
English: (A) Using BiResp Spiromax and a separate ‘reliever inhaler'
Danish: (A) Brug af BiResp Spiromax og en særskilt inhalator med anfaldsmedicin.