FrancophonIA/ELRC3.0 huggingface dataset:
English: There is also an increased risk of systemic undesirable effects when combining fluticasone propionate with other potent CYP3A inhibitors (see section 4.5).
Danish: Der er også øget risiko for systemiske bivirkninger ved kombination af fluticasonpropionat og andre potente CYP3A
English: Once control of asthma is attained treatment should be reviewed and consideration given as to whether patients should be stepped down to an alternative fixed-dose combination of salmeterol and fluticasone propionate containing a lower dose of the inhaled corticosteroid and then ultimately to an inhaled corticosteroid alone.
Danish: Når der er opnået astmakontrol, skal behandlingen vurderes, og det skal overvejes, om patienten skal trappes ned til en fastdosiskombination med salmeterol og fluticasonpropionat, der indeholder en lavere dosis inhaleret kortikosteroid, og i sidste ende til en behandling kun med inhaleret kortikosteroid.
English: • Cataract (cloudy lens in the eye).
Danish: • Grå stær (uklar linse i øjet).
English: System Organ Class Adverse reaction
Danish: Systemorganklasse Bivirkning
English: • Thrush (sore, creamy-yellow, raised patches) in the mouth and throat.
Danish: • Svampeinfektion (ømme, gullige til cremefarvede hævede plamager) i mund og hals.
English: The results of both studies showed that treatment with salmeterol/fluticasone propionate 50/250 resulted in a significantly lower annual rate of moderate/severe COPD exacerbations compared with salmeterol (SCO40043: 1.06 and 1.53 per subject per year, respectively, rate ratio of 0.70, 95% CI: 0.58 to 0.83, p<0.001; SCO100250: 1.10 and 1.59 per subject per year, respectively, rate ratio of 0.70, 95% CI: 0.58 to 0.83, p<0.001).
Danish: Resultaterne af begge studier viste, at behandling med salmeterol/fluticasonpropionat 50/250 mikrogram medførte en signifikant lavere årlig hyppighed af moderate/alvorlige KOL-eksacerbationer sammenlignet med salmeterol (SCO40043: hhv. 1,06 og 1,53 pr. person pr. år; risikorate 0,70; 95 % CI 0,58-0,83; p<0,001.
English: If you feel more wheezy, your chest feels tight more often or you need to use more of your fast-acting ‘reliever' medicine, your chest condition may be getting worse and you could become seriously ill. You should continue to take Aerivio Spiromax but do not increase the number of puffs you take.
Danish: Hvis din vejrtrækning bliver mere hvæsende, hvis du oftere får en trykkende fornemmelse for brystet, eller hvis du hyppigere har behov for hurtigtvirkende anfaldsmedicin, kan det være, at din sygdom er blevet værre, og du kan evt. blive alvorligt syg.
English: Symptomatic candidiasis of the mouth and throat can be treated with topical anti-fungal therapy whilst still continuing with Aerivio Spiromax.
Danish: Symptomatisk candidiasis i mund og svælg kan behandles med topikal svampebehandling, mens behandlingen med Aerivio Spiromax fortsættes.
English: The time on treatment for 50% of subjects to achieve a first individual well controlled week was 16 days for salmeterol/fluticasone propionate compared with 37 days for the ICS group.
Danish: Efter 16 dages behandling havde 50 % af personerne i salmeterol/fluticasonpropionat-gruppen opnået den første individuelle velkontrollerede uge, mens dette tog 37 dage for ICS-gruppen.
English: Aerivio Spiromax may not be suitable to be taken with some other medicines.
Danish: I nogle tilfælde er det ikke hensigtsmæssigt at tage Aerivio Spiromax sammen med andre former for medicin.
English: The concomitant administration of ketoconazole should be avoided, unless the benefits outweigh the potentially increased risk of systemic effects of salmeterol treatment.
Danish: Samtidig administration af ketoconazol bør undgås, medmindre fordelene opvejer den potentielt øgede risiko for systemiske bivirkninger fra salmeterol.
English: Studies SCO40043 and SCO100250 were randomised, double-blind, parallel-group, replicate studies comparing the effect of salmeterol/fluticasone propionate 50/250 micrograms twice daily (a dose not licensed for COPD treatment in the European Union) with salmeterol 50 micrograms twice daily, on the annual rate of moderate/severe exacerbations in subjects with COPD with FEV1 less than 50% predicted and a history of exacerbations.
Danish: Studierne SCO40043 og SCO100250 var randomiserede, dobbeltblinde replikationsstudier med parallelle grupper, der sammenlignede virkningen af salmeterol/fluticasonpropionat 50/250 mikrogram to gange dagligt (en dosis, der ikke er godkendt til KOL-behandling i EU) med salmeterol 50 mikrogram to gange dagligt på den årlige hyppighed af moderate/svære eksacerbationer hos personer med KOL og FEV1 < 50 % af forventet og eksacerbationer i anamnesen.
English: Absorption
Danish: Elimination
English: Aerivio Spiromax should only be used to treat severe asthma in adults aged 18 years and older and
Danish: Aerivio Spiromax må kun anvendes til at behandle svær astma hos voksne i alderen 18 år og derover
English: Respiratory tract infections
Danish: Fraktur pga. traume
English: A clear benefit has not been shown as compared with inhaled fluticasone propionate alone used as initial maintenance therapy when one or two of the criteria of severity are missing.
Danish: Når et eller to af kriterierne for sværhedsgrad mangler, er der ikke blevet vist en klar fordel ved kombinationsbehandling som førstevalgs-vedligeholdelsesbehandling sammenlignet med inhaleret fluticasonpropionat alene.
English: What you need to know before you use Aerivio Spiromax
Danish: Det skal du vide, før du begynder at bruge Aerivio Spiromax
English: If you are not getting enough medicine into your lungs, it will not help your
Danish: Hvis du ikke får nok medicin ned i lungerne, vil medicinen ikke bedre din astma eller KOL som den skal.
English: • Increased number of colds have been reported in patients with chronic obstructive pulmonary disease
Danish: • Det er blevet rapporteret, at patienter med kronisk obstruktiv lungesygdom (KOL) hyppigere bliver
English: Aerivio Spiromax is not recommended for use in children and adolescents aged less than 18 years.
Danish: Aerivio Spiromax anbefales ikke til børn og unge under 18 år.
English: • A fungal infection in the oesophagus (food canal), which might cause difficulties in swallowing.
Danish: • Svampeinfektion i spiserøret, hvilket kan gøre det vanskeligt at synke.
English: Aerivio Spiromax helps to stop breathlessness and wheeziness coming on.
Danish: Aerivio Spiromax hjælper med at forhindre, at du får åndenød og hvæsende vejrtrækning.
English: There were no other differences in safety profile between the treatment arms.
Danish: Der var ingen forskel i sikkerhedsprofilen mellem
English: Aerivio Spiromax is not recommended for use in either children aged 12 years of age and younger or in adolescents aged 13 to 17 years.
Danish: Aerivio Spiromax bør hverken anvendes til børn på 12 år eller yngre eller til unge i alderen 13 til 17 år.
English: Salmeterol/fluticasone propionate COPD - clinical trials TORCH was a 3-year study to assess the effect of treatment with salmeterol/fluticasone propionate inhalation powder 50/500 micrograms twice daily, salmeterol inhalation powder 50 micrograms twice daily, fluticasone propionate (FP) inhalation powder 500 micrograms twice daily or placebo on all-cause mortality in patients with COPD.
Danish: Kliniske studier med salmeterol/fluticasonpropionat KOL TORCH var et studie af 3 års varighed med henblik på at vurdere virkningen af behandling med salmeterol/fluticasonpropionat inhalationspulver 50/500 mikrogram to gange dagligt, salmeterol inhalationspulver 50 mikrogram to gange dagligt, fluticasonpropionat (FP) inhalationspulver 500 mikrogram to gange dagligt eller placebo på mortalitet uanset årsag hos patienter med KOL.
English: You may be very wheezy and cough or be short of breath.
Danish: Din vejtrækning kan blive meget hvæsende, og du kan hoste og få åndenød.
English: There was no significant difference in probability of bone fracture (5.1% placebo, 5.1% salmeterol, 5.4% FP and 6.3% salmeterol/fluticasone propionate; hazard ratio for salmeterol/fluticasone propionate vs placebo: 1.22, 95%
Danish: Der var ingen signifikant forskel i sandsynligheden for knoglefraktur (5,1 % placebo; 5,1 % salmeterol; 5,4 % FP og 6,3 % salmeterol/fluticasonpropionat.
English: Infections and infestations
Danish: • opkastning og diarré
English: There was an increased reporting of lower respiratory tract infections (particularly pneumonia and bronchitis) in the TORCH study in patients with COPD receiving salmeterol/fluticasone propionate 50/500 micrograms twice daily compared with placebo as well as in studies SCO40043 and SCO100250 comparing a lower dose of salmeterol/fluticasone propionate 50/250 micrograms twice daily, (a dose not authorised for use in COPD) with salmeterol 50 micrograms twice daily only (see section 4.8 and section 5.1).
Danish: Der blev hyppigere rapporteret nedre luftvejsinfektioner (især pneumoni og bronkitis) i TORCH-studiet, hvor patienter med KOL fik salmeterol/fluticasonpropionat 50/500 mikrogram to gange dagligt versus placebo, samt i studierne SCO40043 og SCO100250, der sammenlignede en lavere dosis af salmeterol/fluticasonpropionat 50/250 mikrogram to gange dagligt (en dosis, der ikke er godkendt til KOL) versus salmeterol 50 mikrogram to gange dagligt alene (se pkt.
English: Also sore tongue and hoarse voice and throat irritation.
Danish: Desuden øm tunge og hæshed og halsirritation.
English: Aerivio Spiromax is not indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age.
Danish: Aerivio Spiromax er ikke indiceret til børn på 12 år eller yngre eller til unge i alderen 13 til 17 år.
English: salmeterol placebo
Danish: Hazard ratio vs. placebo
English: • Aching, swollen joints and muscle pain.
Danish: Knogler, led, muskler og bindevæv
English: The safety and efficacy of Aerivio Spiromax in children and adolescents aged less than 18 years of age has not been established.
Danish: Aerivio Spiromax' sikkerhed og virkning hos børn og unge i alderen under 18 år er ikke klarlagt.
English: Aerivio Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting β2 agonist) is appropriate:
Danish: Aerivio Spiromax er indiceret til regelmæssig behandling af patienter med svær astma, hvor anvendelse af et kombinationspræparat (inhaleret kortikosteroid og langtidsvirkende β2-agonist) er hensigtsmæssig: - patienter, hvis astma ikke i tilstrækkelig grad kontrolleres med et kortikosteroidkombinationspræparat af en lavere styrke
English: Hence, clinically significant drug interactions mediated by fluticasone propionate
Danish: Derfor er klinisk signifikante interaktioner forårsaget af fluticasonpropionat ikke sandsynlige.
English: Rinsing your mouth out with water and spitting it out immediately and/or brushing your teeth after taking each dose of your medicine may help.
Danish: Det kan hjælpe at skylle munden med vand og straks spytte vandet ud og/eller børste tænder, når du har taget en dosis.
English: Aerivio Spiromax is only appropriate for use in the treatment of patients with severe asthma.
Danish: Aerivio Spiromax er kun hensigtsmæssig til behandling af patienter med svær astma.
English: Due to the fluticasone propionate component, hoarseness and candidiasis (thrush) of the mouth and throat and, rarely of the oesophagus, can occur in some patients.
Danish: Fluticasonpropionat kan forårsage hæshed og candidiasis i mund og svælg og sjældent i øsofagus hos nogle patienter.
English: Aerivio Spiromax is for the treatment of patients with severe asthma only.
Danish: Aerivio Spiromax er kun til behandling af patienter med svær astma.
English: You can also report side effects directly via the national reporting system listed in Appendix V*.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics, ATC code: R03AK06
Danish: Farmakoterapeutisk klassifikation: Midler mod obstruktiv luftvejssygdom, adrenergika i kombination med kortikosteroider/andre lægemidler ekskl.
English: Treatment with Aerivio Spiromax should not be stopped abruptly in patients with asthma due to risk of exacerbation.
Danish: På grund af risikoen for eksacerbationer bør behandling med Aerivio Spiromax ikke stoppes pludseligt hos patienter med astma.
English: Tell your doctor if you are taking the following medicines, before starting to use Aerivio Spiromax:
Danish: Fortæl altid lægen, før du begynder at bruge Aerivio Spiromax, hvis du tager et af følgende lægemidler:
English: One inhalation of 50 micrograms salmeterol and 500 micrograms fluticasone propionate twice daily.
Danish: Én inhalation med 50 mikrogram salmeterol og 500 mikrogram fluticasonpropionat to gange dagligt.
English: Patients with severe lactose intolerance should use this medicine with caution and those with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Patienter med alvorlig lactoseintolerans bør anvende dette lægemiddel med forsigtighed, og patienter med arvelig galactoseintolerans, en særlig form af arvelig lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption bør ikke anvende det. Hjælpestoffet lactose kan indeholde små mængder mælkeprotein, som kan medføre allergiske reaktioner hos patienter, der lider af alvorlig overfølsomhed eller allergi over for mælkeprotein.
English: Aerivio Spiromax is not indicated for use in children and adolescents under the age of 18 years (see Section 4.2).
Danish: Aerivio Spiromax er ikke indiceret til børn og unge under 18 år (se pkt.
English: If a patient with severe COPD has experienced pneumonia, treatment with Aerivio Spiromax should
Danish: Hvis en patient med svær KOL har fået pneumoni, skal behandlingen med Aerivio Spiromax revurderes.
English: Do not open and close the mouthpiece cover unless you are about to use your inhaler.
Danish: Du må ikke åbne og lukke låget på mundstykket, medmindre du
English: To reduce the chance of side effects your doctor will prescribe the lowest dose of this combination of drugs to control your
Danish: For at reducere risikoen for bivirkninger vil lægen ordinere den laveste dosis af dette kombinationslægemiddel, der er nødvendig for at kontrollere din astma eller KOL.
English: The inhaler is white with a semi-transparent yellow mouthpiece cover.
Danish: Inhalatoren er hvid med et halvgennemsigtigt gult låg over mundstykket.
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis du får bivirkninger, skal du kontakte lægen eller apotekspersonalet.
English: Keep the mouthpiece cover closed after removal of the foil wrap.
Danish: Låget på mundstykket skal holdes lukket, efter folien er fjernet.
English: Rounded (moon shaped) face (Cushing's syndrome) Your doctor will check you regularly for any of these side effects and make sure you are taking the lowest dose of this combination of drugs to control your asthma.
Danish: Lægen vil kontrollere dig regelmæssigt for disse bivirkninger og sørge for, at du tager den laveste dosis af dette kombinationslægemiddel til at kontrollere din astma.
English: • Low blood pressure and seizures (fits)
Danish: • lavt blodtryk og krampeanfald.
English: Therefore, concomitant use should be avoided, unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects.
Danish: Samtidig anvendelse skal derfor undgås, medmindre fordelen for patienten opvejer risikoen for systemiske steroidbivirkninger.
English: Your doctor may prescribe an anti-fungal medicine to treat the thrush.
Danish: Lægen kan ordinere et lægemiddel for at bekæmpe
English: There are no data available from clinical trials on overdose with Aerivio Spiromax, however data on overdose with both active substances are given below:
Danish: Der foreligger ingen data fra kliniske studier om overdosering af Aerivio Spiromax.
English: The recommended dose is:
Danish: Virkningerne omfatter:
English: The combination should be avoided unless the benefit outweighs the increased risk of systemic glucocorticoid undesirable effects.
Danish: Kombination bør undgås, medmindre fordelen opvejer den øgede risiko for systemiske kortikosteroid-bivirkninger.
English: Each metered dose contains 50 micrograms of salmeterol (as salmeterol xinafoate) and 500 micrograms of
Danish: Hver afmålt dosis indeholder 50 mikrogram salmeterol (som salmeterolxinafoat) og 500 mikrogram
English: Patients not using inhaled steroids 21/7049
Danish: Patienter, der brugte inhalerede steroider
English: The mouthpiece cover is fixed to your inhaler and must not be taken off. Do not use your inhaler if it is damaged or if the mouthpiece has come apart from your inhaler.
Danish: Brug ikke inhalatoren, hvis den er beskadiget, eller hvis mundstykket har løsnet sig fra inhalatoren.
English: Each metered dose contains 50 micrograms salmeterol (as salmeterol xinafoate) and 500 micrograms fluticasone propionate.
Danish: Hver afmålt dosis indeholder 50 mikrogram salmeterol (som salmeterolxinafoat) og 500 mikrogram fluticasonpropionat.
English: [3%] vs 1 [<1%]) and a similar incidence of inhaled corticosteroid related adverse events (e.g. oral candidiasis - 6 [6%] vs 16 [8%], hoarseness - 2 [2%] vs 4 [2%]) compared with one inhalation twice daily.
Danish: Studiet viste, at sammenlignet med en inhalation to gange dagligt medførte en fordobling af den inhalerede dosis af salmeterol/fluticasonpropionat i op til 14 dage en let øget forekomst af β-agonist-relaterede bivirkninger (tremor: 1 patient [1 %] vs. 0, palpitationer: 6 patienter [3 %] vs. 1 [<1 %], muskelkramper: 6 patienter [3 %] vs. 1 [<1 %]) og en tilsvarende forekomst af bivirkninger relateret til inhaleret kortikosteroid (f.eks. oral candidiasis: 6 patienter [6 %] vs. 16 [8 %], hæshed: 2 patienter [2 %] vs. 4 [2 %]).
English: There have been very rare reports of increases in blood glucose levels (see section 4.8) and this should be considered when prescribing to patients with a history of diabetes mellitus.
Danish: Der har været meget sjældne indberetninger om forhøjede niveauer af blodglucose (se pkt.
English: If you have been told by your doctor that you have an intolerance or allergy to lactose, other sugars, or milk, contact your doctor before taking this medicinal product.
Danish: Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler eller er allergisk over for lactose, andre sukkerarter eller mælk.
English: How to store Aerivio Spiromax
Danish: Sådan skal du bruge Aerivio Spiromax
English: - patients already controlled on a high dose inhaled corticosteroid and long-acting β2 agonist.
Danish: - patienter, hvis astma allerede kontrolleres med højdosis inhaleret kortikosteroid og
English: For patients with COPD cessation of therapy may also be associated with symptomatic decompensation and should be supervised by
Danish: Patienter med KOL bør være under opsyn af en læge, da behandlingsophøret også kan være forbundet med symptomatisk dekompensation.
English: Aerivio Spiromax is indicated in adults 18 years of age and older only.
Danish: Aerivio Spiromax er kun indiceret til voksne i alderen 18 år og derover.
English: • Corticosteroids (by mouth or by injection).
Danish: • Binyrebarkhormoner (som tabletter eller som indsprøjtninger).
English: 3A4 in the gut and liver.
Danish: 4.8 og pkt.
English: Posology
Danish: Kontusioner
English: You must use Aerivio Spiromax every day as directed by your doctor.
Danish: Du skal bruge Aerivio Spiromax hver dag efter lægens anvisning for at sikre, at din astma eller KOL
English: Key findings from SMART: primary endpoint Patient group
Danish: Nøglefund fra SMART: primært endepunkt Antal hændelser (primært endepunkt)/antal
English: FOIL
Danish: KOL
English: White inhaler with a semi-transparent yellow mouthpiece cover.
Danish: Hvid inhalator med et halvgennemsigtigt gult låg over mundstykket.
English: OTHER CONDITIONS AND REQUIREMENTS OF THE
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE
English: The lowest dose of inhaled corticosteroid should be used.
Danish: Der bør anvendes den lavest mulige dosis
English: • Muscle cramps.
Danish: Spiromax.
English: Do not stop or suddenly reduce your dose of Aerivio Spiromax.
Danish: Fortsæt med at tage lægemidlet, indtil lægen fortæller dig, at du skal holde op. Du må ikke holde op eller pludseligt nedsætte din dosis af Aerivio Spiromax.
English: Chronic Obstructive Pulmonary Disease (COPD)
Danish: Luftvejssymptomer (dyspnø)
English: Palpitations
Danish: • mavesmerter
English: What Aerivio Spiromax looks like and contents of the pack Aerivio Spiromax is an inhalation powder.
Danish: Aerivio Spiromax er et inhalationspulver.
English: βeta 2 adrenoreceptor agonists
Danish: Potente CYP3A4-hæmmere
English: It is impossible to accidentally take extra medicine or a double dose in
Danish: Der er ikke risiko for at få en dobbeltdosis i en inhalation.
English: - The active substances are salmeterol and fluticasone propionate.
Danish: Aerivio Spiromax indeholder: - Aktive stoffer: salmeterol og fluticasonpropionat.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Mogilska 80 Str. 31-546 Kraków, Polen Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Your doctor has prescribed this medicine for the treatment of either • Severe asthma, to help prevent attacks of breathlessness and wheeziness,
Danish: • svær astma, for at hjælpe med at forebygge anfald med åndenød og hvæsende vejrtrækning, eller
English: Tel: +370 5 266 02 03
Danish: UAB “Sicor Biotech” Tel: +370 5 266 02 03
English: Excipients
Danish: Artralgi
English: Teva Italia S.r.l.
Danish: Teva Nederland B.V.
English: Tachycardia
Danish: Salmeterol
English: It is recommended to establish the appropriate dosage of inhaled corticosteroid before any fixed-dose combination can be used in patients with severe asthma.
Danish: Hos patienter med svær astma anbefales det, at en passende dosering af inhaleret kortikosteroid fastlægges,
English: • Overactive thyroid gland
Danish: • overaktiv skjoldbruskkirtel
English: Description of selected adverse reactions
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER
English: Each delivered dose (the dose that leaves the mouthpiece) contains 45 micrograms of salmeterol (as salmeterol xinafoate) and 465 micrograms of fluticasone propionate.
Danish: Hver leveret dosis (dosis, der forlader mundstykket) indeholder 45 mikrogram salmeterol (som salmeterolxinafoat) og
English: Use the label on the inhaler to write down
Danish: Låget på mundstykket er fastgjort på inhalatoren og må ikke tages af.
English: - if you regularly drink large amounts of alcohol.
Danish: - hvis du regelmæssigt drikker store mængder alkohol.
English: N % Δ N % Δ N % Δ N % Δ N % Δ
Danish: N % ΔN % ΔN % Δ N % Δ N % Δ
English: However, do not take it if there is less than 4 hours before your next dose.
Danish: Lad dog være med at tage den, hvis der er mindre end 4 timer til din næste dosis.
English: You may need specific blood tests.
Danish: Der kan være brug for at tage nogle bestemte blodprøver.
English: The harmonisation of the quality aspects was not part of this Article 30 procedure.
Danish: Harmoniseringen af kvalitetsaspekterne var ikke en del af denne artikel 30procedure.
English: The Reference Member State was Germany (BfArM).
Danish: Referencemedlemsstaten var Tyskland (BfArM).
English: Follow your doctor's instructions carefully.
Danish: Følg alle lægens anvisninger omhyggeligt.
English: If you are over 70 years your doctor may want to check if you have risk factors for muscular diseases.
Danish: Hvis du er over 70 år gammel, vil din læge måske undersøge, om du har risikofaktorer for muskelsygdomme.