FrancophonIA/ELRC3.0 huggingface dataset:
English: A decision must be made whether to discontinue breastfeeding or to discontinue Aerivio Spiromax therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med Aerivio Spiromax skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de
English: The only safety concerns for human use derived from animal studies of salmeterol and fluticasone propionate given separately were effects associated with exaggerated pharmacological actions.
Danish: På basis af dyrestudier med salmeterol og fluticasonpropionat givet separat er de eneste sikkerhedsmæssige problemstillinger ved human brug virkninger forbundet med for kraftige farmakologiske virkninger.
English: The small increase in β agonist-related adverse events should be taken into account if doubling the dose of salmeterol/fluticasone propionate is considered by the physician in adult patients requiring additional shortterm (up to 14 days) inhaled corticosteroid therapy.
Danish: Der skal tages hensyn til den let øgede forekomst af β-agonist-relaterede bivirkninger, hvis lægen overvejer en fordobling af dosis af salmeterol/fluticasonpropionat til voksne patienter, der har behov for ekstra, kortvarig (op til 14 dage) behandling med inhaleret kortikosteroid.
English: Patients should commence treatment with a fixeddose combination containing a lower dose of the corticosteroid component and will then be titrated up in respect of the corticosteroid dose until control of asthma is achieved.
Danish: Patienterne bør starte behandlingen med en fastdosiskombination, der indeholder en lavere dosis kortikosteroid, hvorefter kortikorsteroiddosis trappes op, indtil der opnås astmakontrol.
English: It is important, therefore, that the patient is reviewed regularly and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is
Danish: Det er derfor vigtigt, at patienten vurderes regelmæssigt, og at dosis af inhaleret kortikosteroid reduceres til den laveste dosis, der kan opretholde en effektiv astmakontrol.
English: Prior to run-in, subjects discontinued use of previous COPD medications except short-acting bronchodilators.
Danish: Før indkøring seponerede personerne deres tidligere KOL-medicin undtagen hurtigtvirkende bronkodilatatorer.
English: In an interaction study in healthy subjects with intranasal fluticasone propionate, ritonavir (a highly potent cytochrome P450 3A4 inhibitor) 100 mg twice daily increased the fluticasone propionate plasma concentrations several hundred fold, resulting in markedly reduced serum cortisol concentrations.
Danish: I et interaktionsstudie med intranasalt fluticasonpropionat hos raske personer øgede ritonavir (en højpotent CYP3A4-hæmmer) 100 mg to gange dagligt plasmakoncentrationen af fluticasonpropionat flere hundrede gange, hvilket resulterede i markant reducerede cortisolkoncentrationer i serum.
English: • Fluticasone propionate is a corticosteroid which reduces swelling and irritation in the lungs.
Danish: • Fluticasonpropionat tilhører en gruppe lægemidler, der kaldes kortikosteroider (binyrebarkhormon), der nedsætter hævelse og irritation i lungerne.
English: EXP Use within 3 months of removing from foil wrapping.
Danish: EXP: Anvendes inden for 3 måneder efter, at inhalatoren er taget ud af folien.
English: Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, cataract and glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children) (see Paediatric population sub-heading below for information on the systemic effects of inhaled corticosteroids in children and adolescents).
Danish: Mulige systemiske virkninger omfatter Cushings syndrom, cushingoide træk, adrenal suppression, nedsat knoglemineraltæthed, katarakt og glaukom samt sjældnere en række psykiske eller adfærdsmæssige virkninger, herunder psykomotorisk hyperaktivitet, søvnforstyrrelser, angst, depression eller aggression (især hos børn) (se underafsnittet ”Pædiatrisk population” nedenfor for oplysninger om systemiske virkninger af inhalerede kortikosteroider hos børn og unge).
English: • A reduction in the amount of potassium in the blood (you may get an uneven heartbeat, muscle
Danish: • En nedsat mængde kalium i blodet (dit hjerteslag kan blive uregelmæssigt, du kan opleve muskelsvaghed og få kramper).
English: If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical
Danish: Ved symptomer som sløret syn eller andre synsforstyrrelser bør det overvejes at henvise patienten til oftalmolog med henblik på vurdering af de mulige årsager; disse kan være grå stær, glaukom eller sjældne sygdomme såsom central serøs korioretinopati (CSCR), som er indberettet efter brug af systemiske og topikale kortikosteroider.
English: Both hoarseness and the incidence of candidiasis of the mouth and throat may be relieved by rinsing the mouth with water and spitting the water out and/or brushing the teeth after using the product.
Danish: Både hæshed og forekomst af candidiasis i mund og svælg kan mindskes ved at skylle munden med vand og spytte vandet ud og/eller børste tænder efter inhalation.
English: The average improvement over three years for salmeterol/fluticasone propionate compared with placebo was -3.1 units (95% CI: -4.1 to -2.1; p<0.001) and when compared with salmeterol was -2.2 units (p<0.001) and when compared with FP was -1.2 units (p=0.017).
Danish: Den gennemsnitlige forbedring efter tre år for salmeterol/fluticasonpropionat i forhold til placebo var -3,1 enheder (95 % CI: -4,1 til -2,1; p<0,001); -2,2 enheder (p<0,001) sammenlignet med salmeterol og -1,2 enheder (p=0,017) sammenlignet med FP.
English: Aerivio Spiromax has no or negligible influence on the ability to drive and use machines.
Danish: Aerivio Spiromax påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene
English: If this happens stop using your Aerivio Spiromax inhaler.
Danish: Hvis dette sker, skal du straks holde op med at bruge din Aerivio Spiromaxinhalator.
English: Children received either salmeterol/fluticasone propionate (50/100 micrograms) or fluticasone propionate (100 micrograms) alone twice daily.
Danish: Børnene fik enten salmeterol/fluticasonpropionat (50/100 mikrogram) eller fluticasonpropionat (100 mikrogram) alene 2 gange dagligt.
English: The estimated 3-year probability of having pneumonia reported as an adverse event was 12.3% for placebo, 13.3% for salmeterol, 18.3% for FP and 19.6% for salmeterol/fluticasone propionate (hazard ratio for salmeterol/fluticasone propionate vs placebo: 1.64, 95% CI: 1.33 to 2.01, p<0.001).
Danish: Den estimerede 3-års sandsynlighed for, at pneumoni rapporteres som en bivirkning, var 12,3 % for placebo, 13,3 % for salmeterol, 18,3 % for FP og 19,6 % for salmeterol/fluticasonpropionat (hazard ratio for salmeterol/fluticasonpropionat vs. placebo: 1,64; 95 % CI: 1,33-2,01; p<0,001).
English: Suomi/Finland Teva FinlandPuh/Tel: +358 20 180 5900
Danish: Puh /Tel: +358 20 180 5900
English: A flow rate of greater than 60L/min is required for optimal delivery of drugs to the lungs through the multidose dry powder Spiromax inhaler.
Danish: En flowhastighed på over 60 l/min er nødvendig for optimal levering af lægemiddel til lungerne via
English: Beta adrenergic blockers may weaken or antagonise the effect of salmeterol.
Danish: Betablokkere kan svække virkningen af salmeterol eller have en antagonistisk virkning.
English: Aerivio Spiromax should be used with caution in patients with severe cardiovascular disorders or heart rhythm abnormalities and in patients with diabetes mellitus, thyrotoxicosis, uncorrected hypokalaemia or patients predisposed to low levels of serum potassium.
Danish: Aerivio Spiromax skal anvendes med forsigtighed til patienter med svære hjerte-kar-sygdomme eller forstyrrelser i hjerterytmen samt hos patienter med diabetes mellitus, tyreotoksikose, ikke korrigeret hypokaliæmi og patienter disponeret for lav serumkalium.
English: Aerivio Spiromax is not likely to affect your ability to drive or use machines.
Danish: Det er ikke sandsynligt, at Aerivio Spiromax vil påvirke din evne til at føre motorkøretøj eller betjene
English: Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, acute adrenal crisis and growth retardation in children and adolescents and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression.
Danish: Mulige systemiske virkninger omfatter Cushings syndrom, cushingoide træk, adrenal suppression, akut adrenal krise og væksthæmning og sjældnere en række forskellige psykiske eller adfærdsmæssige virkninger, herunder psykomotorisk hyperaktivitet, søvnforstyrrelser, angst, depression eller aggression.
English: Once control of asthma is achieved patients should be reviewed regularly and the dose of inhaled corticosteroid titrated downwards as appropriate to maintain disease control.
Danish: Når der er opnået astmakontrol, skal behandlingen vurderes regelmæssigt, og dosis af inhaleret kortikosteroid nedtrappes hensigtsmæssigt for at opretholde sygdomskontrol.
English: Angioedema (mainly facial and oropharyngeal
Danish: Angioødem (primært i ansigt og orofaryngealt ødem)
English: Each dose contains approximately 10 milligrams of lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver dosis indeholder ca. 10 milligram lactose (som monohydrat).
English: In a 12-week trial of children aged 4 to 11 years [n=257] treated with either salmeterol/fluticasone propionate 50/100 or salmeterol 50 micrograms + fluticasone propionate 100 micrograms both twice daily, both treatment arms experienced a 14% increase in peak expiratory flow rate as well as improvements in symptom score and rescue salbutamol use.
Danish: I et 12-ugers forsøg med børn i alderen 4 til 11 år [n=257], der blev behandlet 2 gange dagligt med enten salmeterol/fluticasonpropionat 50/100 mikrogram eller salmeterol 50 µg + fluticasonpropionat 100 µg, oplevede begge behandlingsgrupper en 14 % stigning i den maksimale eksspiratoriske flowhastighed samt forbedringer i symptomscore og brug af salbutamol som akutmedicin.
English: Aerivio Spiromax contains salmeterol and fluticasone propionate, which have differing modes of action.
Danish: Aerivio Spiromax indeholder salmeterol og fluticasonpropionat, der har forskellige virkningsmekanismer.
English: Possible systemic effects in these age groups include Cushing's syndrome, Cushingoid features, adrenal suppression and growth retardation in children and adolescents (see section 4.4).
Danish: Mulige systemiske bivirkninger i disse aldersgrupper omfatter Cushings syndrom, cushingoide træk, adrenal suppression og væksthæmning (se pkt.
English: See leaflet for further information
Danish: Læs indlægssedlen for yderligere information.
English: If a patient with severe COPD has experienced pneumonia, treatment with Aerivio Spiromax should be re-evaluated.
Danish: Hvis en patient med svær KOL har fået pneumoni, skal behandlingen med Aerivio Spiromax evalueres igen.
English: Subjects used salbutamol on an as-needed
Danish: Personerne anvendte salbutamol efter behov i alle studierne.
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: The respective mechanisms of action of both active substances are discussed below.
Danish: Virkningsmekanismen for hvert af stofferne er beskrevet nedenfor.
English: Pneumonia-related events were reported for 55 (7%) subjects in the salmeterol/fluticasone propionate 50/250 micrograms twice daily group and 25 (3%) in the salmeterol group.
Danish: Pneumoni-relaterede bivirkninger blev rapporteret hos 55 (7 %) personer i gruppen med salmeterol/fluticasonpropionat 50/250 mikrogram to gange dagligt og hos 25 (3 %) i salmeterolgruppen.
English: The increased incidence of reported pneumonia with salmeterol/fluticasone propionate 50/250 micrograms twice daily appears to be of similar magnitude to the incidence reported following treatment with salmeterol/fluticasone propionate 50/500 micrograms twice daily in TORCH.
Danish: Den øgede forekomst af rapporterede tilfælde af pneumoni med salmeterol/fluticasonpropionat 50/250 mikrogram to gange dagligt forekommer at være af samme størrelsesorden som den rapporterede forekomst efter behandling med salmeterol/fluticasonpropionat 50/500 mikrogram to gange dagligt i TORCH.
English: Cardiac arrhythmias (including supraventricular tachycardia and extrasystoles).
Danish: Hjertearytmier (herunder supraventrikulær takykardi
English: Aerivio Spiromax 50 micrograms/500 micrograms inhalation powder
Danish: Aerivio Spiromax 50 mikrogram/500 mikrogram inhalationspulver
English: Pooled results across the 3 treatment levels *Well controlled asthma - less than or equal to 2 days with symptom score greater than 1 (symptom score 1 defined as ‘symptoms for one short period during the day'), SABA use on less than or equal to 2 days and less than or equal to 4 occasions/week, greater than or equal to 80% predicted morning peak expiratory flow, no night-time awakenings, no exacerbations and no side effects enforcing a change in therapy **Total control of asthma - no symptoms, no SABA use, greater than or equal to 80% predicted morning peak expiratory flow, no night-time awakenings, no exacerbations and no side effects enforcing a change in
Danish: *Velkontrolleret astma: op til 2 dage med symptomscore over 1 (symptomscore 1 defineret som 'symptomer i en kort periode i løbet af dagen'), anvendelse af SABA i op til 2 dage og op til 4 gange/uge, maksimalt eksspiratorisk flow om morgenen ≥ 80 % af forventet, ingen natlig opvågnen, ingen eksacerbationer og ingen bivirkninger, der medførte en ændring i behandlingen.
English: When it is appropriate to titrate down to a lower strength not available for Aerivio Spiromax, a change to an alternative fixed-dose combination of salmeterol and fluticasone propionate containing a lower dose of the inhaled corticosteroid is
Danish: Når det er hensigtsmæssigt at titrere ned til en lavere styrke, der ikke findes for Aerivio Spiromax, er det nødvendigt at ændre til en fastdosiskombination af salmeterol og fluticasonpropionat, der indeholder en lavere dosis inhaleret kortikosteroid.
English: If you are breastfeeding, check with your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du ammer, skal du spørge lægen eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: This translates to a reduction in the rate of moderate to severe exacerbations of 25% (95% CI: 19% to 31%; p<0.001) compared with placebo, 12% compared with salmeterol (95% CI: 5% to 19%, p=0.002) and 9% compared with FP (95% CI: 1% to 16%, p=0.024).
Danish: Dette giver en reduktion af hyppigheden af moderate til svære eksacerbationer på 25 % (95 % CI: 19-31 %; p<0,001) sammenlignet med placebo, 12 % sammenlignet med salmeterol (95 % CI: 5-19 %; p=0,002) og 9 % sammenlignet med FP (95 % CI: 1-16 %; p=0,024).
English: Patients should be advised to have their inhaler to be used for relief in an acute asthma attack available at all times.
Danish: Patienterne skal rådes til altid at have deres inhalator på sig, så den kan anvendes til lindring af akutte anfald.
English: Rarely, Aerivio Spiromax may cause cardiac arrhythmias e.g. supraventricular tachycardia, extrasystoles and atrial fibrillation, and a mild transient reduction in serum potassium at high therapeutic doses.
Danish: I sjældne tilfælde kan Aerivio Spiromax ved høje terapeutiske doser forårsage hjertearytmi, f.eks. supraventrikulær takykardi, ekstrasystoler og atrieflimmer, og en let, forbigående reduktion i serumkalium.
English: Patients should not be initiated on Aerivio Spiromax during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.
Danish: Patienterne må ikke starte behandling med Aerivio Spiromax under en eksacerbation, eller hvis de har signifikant eller akut forværring.
English: In patients with asthma or COPD a lesser degree of systemic exposure to inhaled fluticasone propionate has been
Danish: Hos patienter med astma eller KOL er systemisk eksponering blevet observeret i mindre grad efter inhalation af
English: Serious asthma-related adverse events and exacerbations may occur during treatment with Aerivio Spiromax.
Danish: Der kan opstå alvorlige astmarelaterede bivirkninger og eksacerbationer under behandling med Aerivio Spiromax.
English: Patients may notice a taste when using Aerivio Spiromax due to the lactose excipient.
Danish: Patienterne registrerer muligvis en smag, når de bruger Aerivio Spiromax.
English: The primary endpoint was reduction in all-cause mortality at 3 years for salmeterol/fluticasone
Danish: Det primære endepunkt var reduktion i mortalitet uanset årsag efter 3 år for salmeterol/fluticasonpropionat vs. placebo.
English: • Use within 3 months of removing from the foil wrapping.
Danish: • Anvendes inden for 3 måneder efter, at inhalatoren er taget ud af folien.
English: This makes it easier for air to get in and out.
Danish: Det gør det nemmere at trække vejret.
English: - if you are allergic (hypersensitive) to salmeterol, fluticasone propionate or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Aerivio Spiromax: - hvis du er allergisk (overfølsom) over for salmeterol, fluticasonpropionat eller et af de øvrige indholdsstoffer i Aerivio Spiromax (angivet i punkt 6).
English: The main pathway is metabolism to an inactive carboxylic acid metabolite, by the cytochrome P450 enzyme CYP3A4.
Danish: Den primære vej er CYP3A4metabolisering til en inaktiv carboxylsyremetabolit.
English: Co-administration of erythromycin (500 mg orally three times a day) and salmeterol (50 micrograms inhaled twice daily) in 15 healthy subjects for 6 days resulted in a small but non-statistically significant increase in salmeterol exposure (1.4-fold Cmax and 1.2-fold AUC).
Danish: Samtidig administration af erythromycin (500 mg oralt tre gange dagligt) og salmeterol (50 mikrogram inhaleret to gange dagligt) i 6 dage hos 15 raske personer medførte en lille, men ikke statistisk signifikant forhøjelse i eksponeringen for salmeterol (1,4 gange Cmax og 1,2 gange AUC).
English: Co-administration of ketoconazole (400 mg orally once daily) and salmeterol (50 micrograms inhaled twice daily) in 15 healthy subjects for 7 days resulted in a significant increase in plasma salmeterol exposure (1.4fold Cmax and 15-fold AUC).
Danish: Samtidig administration af ketoconazol (400 mg oralt en gang dagligt) og salmeterol (50 mikrogram inhaleret to gange dagligt) i 7 dage hos 15 raske personer medførte signifikant øget plasma-eksponering af salmeterol (1,4 gange Cmax og 15 gange AUC).
English: In the subset of steroid naive asthmatics the time to an individual well controlled week was 16 days in the salmeterol/fluticasone propionate treatment compared with 23 days following treatment with ICS.
Danish: I undergruppen af astmatikere, der ikke tidligere havde fået steroid, gik der 16 dage, før der blev opnået en individuel velkontrolleret uge i salmeterol/fluticasonpropionat-gruppen sammenlignet med 23 dage i ICS-gruppen.
English: Aerivio Spiromax 50 micrograms/500 micrograms inhalation powder salmeterol/fluticasone propionate
Danish: Aerivio Spiromax 50 mikrogram/500 mikrogram inhalationspulver salmeterol/fluticasonpropionat
English: Adverse event profiles were similar with the exception of a higher incidence of pneumonias and known local side effects (candidiasis and dysphonia) in the salmeterol/fluticasone propionate 50/250 micrograms twice daily group compared with salmeterol.
Danish: Bivirkningsprofilerne var sammenlignelige med undtagelse af en højere forekomst af pneumoni og kendte lokale bivirkninger (candidiasis og dysfoni) i gruppen med salmeterol/fluticasonpropionat 50/250 mikrogram to gange dagligt versus salmeterolgruppen.
English: Other unidentified metabolites are also found in the faeces.
Danish: Der er fundet andre, ikke identificerede metabolitter i fæces.
English: Findings for the secondary efficacy measures (time to first moderate/severe exacerbation, the annual rate of exacerbations requiring oral corticosteroids, and pre-dose morning (AM) FEV1) significantly favoured salmeterol/fluticasone propionate 50/250 micrograms twice daily over salmeterol.
Danish: Resultater for sekundære endepunkter (tid til første moderate/svære eksacerbation, årlig hyppighed af eksacerbationer, som krævede oralt kortikosteroid og FEV1 før dosering om morgenen) favoriserede signifikant salmeterol/fluticasonpropionat 50/250 mikrogram to gange dagligt i forhold til salmeterol.
English: Salmeterol and FP significantly reduced exacerbation rates compared with placebo by 15% (95% CI: 7% to 22%; p<0.001) and 18% (95% CI: 11% to 24%; p<0.001) respectively.
Danish: Salmeterol og FP reducerede hyppigheden af eksacerbationer signifikant i forhold til placebo med hhv. 15 % (95 % CI: 7-22 %; p<0,001) og 18 % (95 % CI: 11-24 %; p<0,001).
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 forblive opmærksom på risikoen for pneumoni hos patienter med KOL, da de kliniske symptomer ved denne infektion kan forveksles med symptomerne på en KOL-eksacerbation.
English: Salmeterol produces a longer duration of bronchodilation, lasting for at least 12 hours, than recommended doses of conventional short-acting β2 agonists.
Danish: Salmeterol er en selektiv langtidsvirkende (12 timer) β2-agonist med en lang sidekæde, som binder til Salmeterol giver en længere varende bronkodilatation (varighed mindst 12 timer) end anbefalede doser af konventionelle hurtigtvirkende β2-agonister.
English: When to start using a new Aerivio Spiromax
Danish: Hvornår skal du begynde at bruge en ny Aerivio Spiromax
English: Patients with severe asthma and COPD were shown to be able to generate sufficient inspiratory flow rate when they breathed in forcefully through the Spiromax device to enable the delivery of the required therapeutic dose to the lungs (see also section 5.1 - last five paragraphs)
Danish: Det er blevet vist, at patienter med svær astma og KOL kan generere en tilstrækkelig inspiratorisk flowhastighed, når de tager en kraftig indånding gennem Spiromax-inhalatoren, til at muliggøre levering af den påkrævede terapeutiske dosis i lungerne (se også ”Maksimal inspiratorisk flowhastighed gennem Spiromax-inhalationsdevice”
English: Potentially serious hypokalaemia may result from β2 agonist therapy.
Danish: Behandling med β2-agonister kan medføre potentielt alvorlig hypokaliæmi.
English: As Aerivio Spiromax contains salmeterol and fluticasone propionate, the type and severity of adverse reactions associated with each of the active substance may be expected.
Danish: Da Aerivio Spiromax indeholder salmeterol og fluticasonpropionat, må der forventes samme type og sværhedsgrad af bivirkninger som ved administration af hvert af disse aktive stoffer.
English: Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of the inhaled corticosteroid and therefore a change to an alternative fixed-dose combination of salmeterol and fluticasone propionate containing a lower dose of the inhaled corticosteroid is required.
Danish: Når astmasymptomerne er under kontrol, kan det overvejes gradvist at reducere dosis af inhaleret kortikosteroid, og det er derfor nødvendigt at ændre til en fastdosiskombination af salmeterol og fluticasonpropionat, der indeholder en lavere dosis inhaleret kortikosteroid.
English: Pneumonia (in COPD patients)
Danish: Pneumoni hos patienter med KOL