FrancophonIA/ELRC3.0 huggingface dataset:
English: Budesonide is excreted in breast milk.
Danish: Budesonid udskilles i mælk.
English: Do not breathe out through your inhaler.
Danish: Du må ikke ånde ud gennem inhalatoren.
English: Formoterol itself may induce prolongation of the QTc-interval.
Danish: Formoterol kan inducere forlængelse af QTc-intervallet.
English: The inhaler is made of acrylonitrile butadiene styrene (ABS), polyethylene terephthalate (PT) , and polypropylene (PP).
Danish: Inhalatoren er fremstillet af acrylonitril-butadien-styren (ABS), polyethylenterephthalat (PT) og polypropylen (PP).
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Generelt
English: After inhalation, 8% to 13% of the delivered dose of formoterol is excreted unmetabolised in the urine.
Danish: Efter inhalation udskilles 8 % til 13 % af den afgivne dosis formoterol uomdannet i urinen.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF
Danish: SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
English: Your doctor may need to change your treatment in order to reduce your symptoms of asthma (breathlessness, wheezing and cough) and improve your asthma control and make your breathing easier.
Danish: Din læge skal måske ændre din behandling for et reducere dine astmasymptomer (åndenød, hvæsende vejrtrækning og hoste) og forbedre kontrollen med din astma og lette din vejrtrækning.
English: The excipient lactose contains small amounts of milk proteins which may cause allergic reactions.
Danish: Lactose indeholder små mængder af mælkeproteiner, som kan forårsage allergiske reaktioner.
English: Do not stop using your inhaler without telling your doctor first.
Danish: Hold ikke op med at bruge din inhalator, uden først at fortælle din læge om det.
English: Caution should be observed when treating patients with prolongation of the QTc-interval.
Danish: Der skal udvises forsigtighed ved behandling af patienter med forlænget QTc-interval.
English: • Use the ‘reliever inhaler' when you get asthma symptoms, to make it easier to breathe again.
Danish: • Brug inhalatoren med anfaldsmedicin, når du får astmasymptomer, for at gøre det lettere at trække vejret igen.
English: In addition L-Dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards β2 sympathomimetics.
Danish: Desuden kan L-Dopa, L-thyroxin, oxytocin og alkohol svække hjertets tolerance over for β2-adrenerge sympatomimetika.
English: The metabolites of budesonide are eliminated in urine as such or in conjugated form.
Danish: Budesonids metabolitter udskilles i urinen som sådan eller i konjugeret form.
English: Formoterol has a high systemic clearance (approximately 1.4 L/min) and the terminal elimination half-life averages 17 hours.
Danish: Formoterol har en høj systemisk clearance (ca. 1,4 l/min), og den terminale eliminationshalveringstid er i gennemsnit 17 timer.
English: • If you open and close the mouthpiece without taking an inhalation, the dose indicator will still register it as a count.
Danish: • Hvis du åbner og lukker mundstykket uden at tage en inhalation, vil dosisindikatoren tælle det som en dosis.
English: If any of these symptoms bother you, or if symptoms such as headache, tiredness, nausea (feeling sick) or vomiting (being sick) occur, please contact your doctor immediately.
Danish: Hvis nogen af disse symptomer generer dig, eller hvis symptomer som hovedpine, træthed, kvalme eller opkastninger forekommer, skal du straks kontakte din læge.
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 justere dosen af dette lægemiddel til den laveste dosis, der kan kontrollere din astma.
English: The glucocorticosteroid activity of the major metabolites, 6-beta-hydroxy-budesonide and 16-alfa-hydroxyprednisolone, is less than 1% of that of budesonide.
Danish: Aktiviteten af de vigtigste metabolitter, 6-beta-hydroxy-budesonid og 16-alfa-hydroxy-prednisolon, er mindre end 1 % af budesonids.
English: The lowest effective dose of budesonide needed to maintain adequate asthma control should be used.
Danish: Den laveste effektive budesonid-dosis, som er nødvendig for at opnå tilstrækkelig astmakontrol, bør anvendes.
English: Close your lips around the mouthpiece.
Danish: Luk læberne omkring mundstykket.
English: Each pack contains 1 inhaler.
Danish: Hver pakning indeholder 1 inhalator.
English: It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored.
Danish: Det anbefales regelmæssigt at følge højden hos børn, som får langvarig behandling med inhaleret kortikosteroid.
English: • Keep the mouthpiece closed all the time unless you are about to use your inhaler.
Danish: • Hold mundstykket lukket hele tiden, medmindre du skal til at bruge din inhalator.
English: You may need to take other medicines if you develop allergic or arthritic symptoms.
Danish: Det kan være nødvendigt, at du tager anden medicin, hvis du udvikler allergiske reaktioner eller gigtsymptomer.
English: As budesonide and formoterol are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver cirrhosis.
Danish: Da budesonid og formoterol primært udskilles via hepatisk metabolisme, kan en øget eksponering forventes hos patienter med alvorlig levercirrhose.
English: However, these animal experimental results do not seem to be relevant in humans at the recommended doses.
Danish: Disse testresultater hos dyr forekommer imidlertid ikke at være relevante for mennesker ved de anbefalede doser.
English: It is also important to advise patients not to shake the inhaler before use and not to breathe out through the Spiromax and not to block the air vents when they are preparing the “Breathe” step.
Danish: Det er også vigtigt at informere patienterne om ikke at ryste inhalatoren før brug, ikke at puste ud gennem Spiromax og ikke at blokere ventilationsåbningerne, når de gør klar til ”Indåndingstrinnet”.
English: Budesonide undergoes an extensive degree (approximately 90%) of biotransformation on first passage through the liver to metabolites of low glucocorticosteroid activity.
Danish: Budesonid metaboliseres i omfattende grad (ca. 90 %) ved første passage gennem leveren til metabolitter med lav glukokortikoidaktivitet.
English: • Steroid medicines that you take by mouth (such as prednisolone).
Danish: • Steroider, som du tager gennem munden (f.eks. prednisolon).
English: When to start using a new Spiromax
Danish: Hvornår skal jeg bruge en ny Spiromax?
English: Volume of distribution is about 4 L/kg for formoterol and 3 L/kg for budesonide.
Danish: Fordelingsvolumenet er ca. 4 l/kg for formoterol og 3 l/kg for budesonid.
English: How to take an inhalation Every time you need to take an inhalation, follow the instructions below.
Danish: Sådan tager du en inhalation Hver gang, du har brug for at tage en inhalation, skal du følge nedenstående anvisninger.
English: This is less likely to occur if you rinse your mouth out with water after using your medicine.
Danish: Det er mindre sandsynligt, at dette forekommer, hvis du skyller munden med vand, hver gang du har taget medicinen.
English: When reducing steroid tablets, you may feel generally unwell even though your chest symptoms may be improving.
Danish: Når antallet af steroidtabletter reduceres, vil du muligvis føle dig utilpas, selvom dine symptomer i brystet forbedres.
English: The systemic bioavailability is about 61% of the delivered dose.
Danish: Den systemiske biotilgængelighed er ca. 61 % af den afgivne dosis.
English: The specific properties of budesonide and formoterol allow the combination to be used as maintenance treatment of asthma.
Danish: De specifikke egenskaber af budesonid og formoterol gør, at kombinationen kan anvendes som vedligeholdelsesbehandling af astma.
English: Cleaning your Spiromax
Danish: Sådan rengøres Spiromax
English: Rinse your mouth with water after every dose, and spit it out.
Danish: Skyl munden med vand efter hver dosis, og spyt det ud.
English: Open the mouthpiece cover by folding it down until one loud click is heard.
Danish: Åbn mundstykkets låg ved at folde det ned, indtil der høres et højt klik.
English: Candida infections in the oropharynx
Danish: Candida-infektioner i orofarynx
English: As such, the patients should be advised to read the patient information leaflet carefully and follow the instructions for use as detailed in the leaflet.
Danish: Patienterne skal derfor informeres om at læse indlægssedlen omhyggeligt og følge brugsanvisningen som beskrevet i indlægssedlen.
English: Particular caution is recommended in unstable asthma with variable use of rescue bronchodilators, in acute severe asthma as the associated risk may be augmented by hypoxia and in other conditions when the likelihood for hypokalaemia is increased.
Danish: Det anbefales at udvise særlig forsigtighed ved ustabil astma med varierende brug af bronkodilatorer som anfaldsmedicin; ved akut svær astma, da den forbundne risiko kan forstærkes af hypoxi, og under andre forhold, når sandsynligheden for hypokaliæmi er øget.
English: Mild irritation in the throat, coughing, hoarseness
Danish: Let irritation i halsen, hoste, hæshed
English: OTHER SPECIAL WARNING(S), IF NECESSARY Front panel: Not for use in children and adolescents.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Karton-forside: Må ikke anvendes til børn og unge.
English: • Thrush (a fungal infection) in the mouth.
Danish: • Trøske (en svampeinfektion) i munden.
English: Recommended doses:
Danish: Anbefalede doser:
English: For formoterol, maximal plasma concentration was similar after administration of the fixed combination.
Danish: For formoterol var den maksimale plasmakoncentration sammenlignelig efter administration af fastdosiskombinationen.
English: The mean PIFR achieved by patients with asthma 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 var over 60 l/min, en flow-hastighed, hvor de 2 undersøgte devices vides at levere en sammenlignelig mængde lægemiddel til lungerne.
English: The prolonged treatment with high doses of inhaled corticosteroids, particularly higher than recommended doses, may also result in clinically significant adrenal suppression.
Danish: Langtidsbehandling med høje doser af inhalerede kortikosteroider, især højere doser end de anbefalede, kan også resultere i klinisk signifikant binyrebarksuppression.
English: If this is not possible the time interval between administration of the inhibitor and budesonide should be as long as possible (see section 4.4).
Danish: Hvis dette ikke er muligt, skal tidsintervallet mellem administration af hæmmeren og budesonid være så langt som muligt (se pkt.
English: Always keep your ‘reliever inhaler' with you and use it to relieve sudden attacks of breathlessness and wheezing.
Danish: Hav altid din inhalator med anfaldsmedicin 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: • Sudden acute wheezing and/or shortness of breath immediately after using your inhaler (also referred to as ‘paradoxical bronchospasm'.
Danish: • Pludselig akut hvæsen og/eller åndenød umiddelbart efter, at du har brugt inhalatoren (betegnes også ”paradoks bronkospasme”).
English: The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Danish: Dosis skal titreres til den laveste dosis, der kan opretholde effektiv symptomkontrol.
English: The systemic bioavailability is approximately 49% of the delivered dose.
Danish: Den systemiske biotilgængelighed er ca. 49 % af den afgivne dosis.
English: PHARMACEUTICAL FORM AND CONTENTS Inhalation powder
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Inhalationspulver
English: Spiromax is a breath actuated, inspiratory flow-driven inhaler, which means that the active substances are delivered into the airways when the patient inhales through the mouthpiece.
Danish: Spiromax er en åndedrætsaktiveret, inspiratorisk flow-drevet inhalator, hvilket betyder, at de aktive stoffer frigives til luftvejene, når patienten inhalerer gennem mundstykket.
English: Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Netherlands
Danish: Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Holland
English: Use of your ‘reliever inhaler' should not exceed 8 inhalations (puffs) in any 24 hours and you should not use your ‘reliever inhaler' more often than every 4 hours.
Danish: Du må ikke bruge din inhalator med anfaldsmedicin mere end 8 gange (inhalationer) i døgnet, og du bør ikke bruge din inhalator med anfaldsmedicin oftere end hver 4. time.
English: If it is nearly time for your next dose just take your next dose at the usual time.
Danish: Tag blot den næste dosis på det sædvanlige tidspunkt, hvis tiden næsten er inde til at tage din næste dosis.
English: In addition consideration should be given to referring the patient to a paediatric respiratory specialist.
Danish: Henvisning til en pædiatrisk lungespecialist bør desuden overvejes.
English: Adverse reactions, which have been associated with budesonide or formoterol, are given below and listed by system organ class and frequency.
Danish: Bivirkninger, som har været forbundet med budesonid eller formoterol, er angivet nedenfor og opført efter systemorganklasse og hyppighed.
English: Contents of the pack and other information (page 22)
Danish: Pakningsstørrelser og yderligere oplysninger (side 22)
English: Peak Inspiratory Flow Rate through the Spiromax Device
Danish: Maksimal inspiratorisk flow igennem Spiromax-devicet
English: Open: Hold the Spiromax with the mouthpiece cover at the bottom and open the mouthpiece cover by folding it down until it is fully opened when one click is heard.
Danish: Åbning: Hold Spiromax med mundstykkets låg forneden og åbn mundstykkets låg ved at folde det ned, indtil det er helt åbnet, og der høres et klik.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, adrenergics and other drugs for obstructive airway diseases.
Danish: Farmakoterapeutisk klassifikation: Lægemidler mod obstruktiv lungesygdom, adrenerge lægemidler og andre lægemidler mod obstruktiv lungevejssygdom.
English: Systemic effects
Danish: Systemiske påvirkninger
English: However, at therapeutic doses no effects on the suckling child are anticipated.
Danish: Der forventes imidlertid ikke nogen indvirkning på det ammede barn ved terapeutiske doser.
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 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: The exposure of budesonide and formoterol may be increased in patients with liver disease.
Danish: Eksponeringen af budesonid og formoterol kan øges hos patienter med leversygdom.
English: All treatment arms used a short-acting β2 adrenoceptor agonist as needed.
Danish: Alle behandlingsgrupper brugte en korttidsvirkende β2-agonist efter behov.
English: Animal reproduction studies with formoterol have shown a somewhat reduced fertility in male rats at high systemic exposure and implantation losses as well as decreased early postnatal survival and birth weight at considerably higher systemic exposures than those reached during clinical use.
Danish: Reproduktionsstudier med formoterol hos dyr har vist en noget nedsat fertilitet hos hanrotter ved høj systemisk eksponering og implantationstab samt nedsat tidlig postnatal overlevelse og fødselsvægt ved betydeligt højere systemisk eksponering, end der opnås ved klinisk brug.
English: Concomitant treatment with itraconazole, ritonavir or other potent CYP3A4 inhibitors should be avoided (see section 4.5).
Danish: Samtidig behandling med itraconazol, ritonavir eller andre potente CYP3A4-hæmmere bør undgås (se pkt.
English: Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides.
Danish: Hypokaliæmi kan øge tilbøjeligheden til arytmier hos patienter, som behandles med digitalisglykosider.
English: The data from the study indicated that regardless of age and underlying disease severity, children, adolescents and adults with asthma were able to able to achieve inspiratory flow rates through the Spiromax device that were similar to those generated through the marketed multi-dose dry powder inhaler device.
Danish: Data fra studiet viste, at uanset alder og sværhedsgrad af den underliggende sygdom, var børn, unge og voksne med astma 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: In spite of this, a small increase in cortisol suppression was seen after administration of fixed-dose combination compared to the monoproducts.
Danish: På trods af dette sås der en lille stigning i kortisolsuppression efter administration af fastdosiskombinationen sammenlignet med enkeltstofpræparaterne.
English: This helps to prevent asthma symptoms such as breathlessness and wheezing from occurring.
Danish: Dette hjælper med at forebygge astmasymptomer som åndenød og hvæsen.
English: • you have a lung infection.
Danish: • Du har en lungeinfektion.
English: • Chest pain or tightness in the chest (angina pectoris).
Danish: • Brystsmerter eller trykken for brystet (angina pectoris).
English: Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Ireland
Danish: Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Irland
English: In usual practice when control of symptoms is achieved with the twice daily dose regimen with a lower strength product, titration to a lower effective dose could include once daily dosing when, in the opinion of the prescriber, a long-acting bronchodilator is required to maintain control rather than treatment with an inhaled corticosteroid alone.
Danish: Det er normal praksis, at når der er opnået symptomkontrol med dosering to gange dagligt med et præparat af lavere styrke, kan titrering til en lavere, effektiv dosis inkludere dosering én gang dagligt, når en langtidsvirkende bronkodilator efter den ordinerende læges mening er nødvendig for at opretholde kontrollen, frem for udelukkende at behandle med inhaleret kortikosteroid.
English: You should not exceed your prescribed dose without seeking medical advice.
Danish: Du må ikke overskride den ordinerede dosis uden at spørge en læge.
English: The toxicity observed in animal studies with budesonide and formoterol, given in combination or separately, were effects associated with exaggerated pharmacological activity.
Danish: Den observerede toksicitet af budesonid og formoterol, givet i kombination eller separat, i dyrestudier var virkninger forbundet med øget farmakologisk aktivitet.
English: Concomitant use of other β adrenergic medicinal products and anticholinergic medicinal products can have a potentially additive bronchodilating effect.
Danish: Samtidig brug af andre beta-adrenerge lægemidler og antikolinergika kan have en potentielt additiv bronkodilaterende effekt.
English: • Swelling of your face, particularly around your mouth (tongue and/or throat and/or difficulty to swallow) or hives together with difficulties to breathe (angioedema) and/or sudden feeling of faintness.
Danish: • Hævelse i ansigtet, især omkring munden (tunge og/eller svælg og/eller synkebesvær) eller nældefeber kombineret med vejrtrækningsproblemer (angioødem) og/eller pludselig mathedsfornemmelse.
English: It works by relaxing the muscles in your airways.
Danish: Det virker ved at få musklerne i luftvejene til at slappe af.
English: Increasing use of a separate rapid-acting bronchodilator indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy.
Danish: Et øget forbrug af en særskilt hurtigtvirkende bronkodilator indikerer forværring af den tilgrundliggende sygdom, og at astmabehandlingen bør revurderes.
English: Advising the patient to rinse the mouth out with water after each dose will minimise the risk.
Danish: Ved at råde patienten til at skylle munden med vand efter hver dosis minimeres risikoen.
English: For budesonide, AUC was slightly higher, rate of absorption more rapid and maximal plasma concentration higher after administration of the fixed combination.
Danish: For budesonid var AUC lidt højere, absorptionshastigheden hurtigere og den maksimale plasmakoncentration højere efter administration af fastdosiskombinationen.
English: To minimise the risk of oropharyngeal candida infection, the patient should be instructed to rinse their mouth out with water after inhaling the dose.
Danish: For at mindske risikoen for orofaryngeal Candida-infektion bør patienten informeres om at skylle munden med vand efter inhalation af dosis.
English: • Other bronchodilators (such as salbutamol).
Danish: • Andre bronkodilatorer (såsom salbutamol).
English: Inhaled budesonide has less severe adverse reactions than systemic corticosteroids.
Danish: Inhaleret budesonid har færre alvorlige bivirkninger end systemiske kortikosteroider.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/950/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/950/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/950/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/950/002
English: Moderate and severe asthmatic patients were shown to be able to generate sufficient inspiratory flow rate for Spiromax to deliver the therapeutic dose (see section 5.1).
Danish: Det er vist, at moderat og svært astmatiske patienter kan generere tilstrækkeligt inspiratorisk flow til, at Spiromax kan levere den terapeutiske dosis (se pkt.
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 samtidigt med inhaleret budesonid (enkelt dosis på 1000 mikrogram).
English: Candida infection in the oropharynx is due to active substance deposition.
Danish: Candida-infektion i orofarynx skyldes aflejring af aktivt stof.
English: Do not open and close the mouthpiece cover unless you are about to use your inhaler.
Danish: Forsøg ikke at åbne og lukke mundstykkets låg, medmindre du skal til at bruge din inhalator.
English: • Do not use this medicine after the expiry date which is stated on the carton or on the label of your inhaler after EXP.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på pakningen, eller på etiketten til din inhalator efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: There was no evidence of pharmacokinetic interactions between budesonide and formoterol.
Danish: Der var ingen tegn på farmakokinetiske interaktioner mellem budesonid og formoterol.