FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, the corresponding frequency category for each adverse reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: Derudover er den tilsvarende hyppighedskategori for hver bivirkning baseret på følgende konvention: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Limited treatment experience is available for the black population.
Danish: Der er kun ringe erfaring med den sorte population.
English: - you have heart problems.
Danish: - hvis du har hjerteproblemer.
English: The apparent volume of distribution in the terminal phase following inhalation was almost 20-fold larger, which reflects the much slower elimination after inhalation.
Danish: Det tilsyneladende fordelingsvolumen i den terminale fase efter inhalation var næsten 20 gange større, hvilket afspejler den meget langsommere eliminering efter inhalation.
English: Then, inhale the next dose as usual the next day.
Danish: Inhalér derefter næste dosis til sædvanlig tid næste dag.
English: A further 5% of the dose was found in the bile.
Danish: Yderligere 5 % af dosis blev fundet i galden.
English: - Tell your doctor immediately if your COPD symptoms such as breathlessness, wheezing or cough do not improve or get worse.
Danish: Fortæl det øjeblikkeligt til lægen, hvis dine KOL-symptomer som fx stakåndethed, hvæsen eller hoste ikke forbedres eller bliver værre.
English: • Do not handle capsules with wet hands.
Danish: • Håndter ikke kapslerne med fugtige hænder.
English: • Do not press the side buttons more than once.
Danish: • Tryk ikke på sideknapperne mere end én gang.
English: The capsule may be stuck in the capsule chamber.
Danish: Kapsel kan muligvis sidde fast i kammeret.
English: Up to 23% of the delivered dose was found in urine as parent drug.
Danish: Op til 23 % af leveret dosis blev fundet i urin i form af moderstoffet.
English: Fertility and pre- and post-natal development were not affected in rats.
Danish: Fertilitet, præ- og postnatal udvikling var upåvirket hos rotter.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Danish: Tag ikke lægemidlet efter den udløbsdato, der står på pakningen og blisteren efter ”EXP”.
English: Reproduction studies and other data in animals do not indicate a concern regarding fertility in either males or females.
Danish: Reproduktionsstudier og andre data fra dyr indikerer ikke problemer i forbindelse med fertilitet hos hverken mænd eller kvinder.
English: Do not use this medicine to treat a sudden attack of breathlessness or wheezing.
Danish: Brug ikke dette lægemiddel til behandling af pludselige anfald af åndenød eller hvæsen.
English: Ask your pharmacist how to dispose of medicines and inhalers that are no longer required.
Danish: Spørg på apoteket hvordan du skal bortskaffe medicin og inhalatorer, som du ikke længere har behov for.
English: - Please read the instructions at the end of this leaflet for more information on how to use the inhaler.
Danish: - Læs brugsanvisningen sidst i denne indlægsseddel for at få yderligere oplysninger om, hvordan du bruger inhalatoren.
English: If you have questions about how long to continue your treatment with this medicine, talk to your doctor or pharmacist.
Danish: Hvis du har spørgsmål om, hvor lang tid du skal fortsætte din behandling med dette lægemiddel, skal du tale med din læge eller apoteket.
English: Hypokalaemic treatment
Danish: Hypokaliæmisk behandling
English: There is no relevant use of Ultibro Breezhaler in the paediatric population (under 18 years) in the indication COPD.
Danish: Der er ingen relevant brug af Ultibro Breezhaler i den pædiatriske population (under 18 år) ved indikationen KOL.
English: Trough and peak FEV1:
Danish: Dal og peak FEV1:
English: Treatment difference
Danish: Forskel i behandling
English: Where required, cardioselective beta-adrenergic blockers should be preferred, although they should be administered with caution.
Danish: Hvor det er påkrævet, skal kardioselektive beta-adrenerge blokkere foretrækkes, selvom de skal anvendes med forsigtighed.
English: The effect remains constant over the whole 24-h dosing interval.
Danish: Virkningen er konstant over hele 24-timers doseringsintervallet.
English: Reports received from post-marketing experience; frequencies calculated, however, on the basis of clinical trial data.
Danish: Bivirkninger fra efter markedsføring; hyppigheden er dog beregnet ud fra data baseret på kliniske studier.
English: Steady state concentrations of indacaterol were achieved within 12 to 15 days following once-daily administration.
Danish: Steady state koncentrationer for indacaterol blev opnået inden for 12 til 15 dage efter administration én gang dagligt.
English: Carcinogenicity was assessed in a two-year rat study and a six-month transgenic mouse study.
Danish: Karcinogenitet blev vurderet i et toårigt forsøg med rotter og i et seks måneders forsøg med transgene mus.
English: I felt small pieces of the capsule on my tonguedoes this matter?
Danish: Jeg kunne mærke små stykker af kapslen på min tunge - betyder det noget?
English: PA/Alu/PVC - Alu perforated unit-dose blister.
Danish: PA/Alu/PVC - Alu perforeret enkeltdosisblister.
English: This medicine blocks the tightening of these muscles in the lungs, making it easier for air to get in and out of the lungs.
Danish: Dette lægemiddel hindrer, at musklerne i lungerne trækker sig sammen, og gør det derved nemmere at trække vejret ind og ud af lungerne.
English: What should I do if there is powder left inside the capsule?
Danish: Hvad skal jeg gøre, hvis der er overskydende pulver i kapslen?
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, adrenergics in combination with anticholinergics, ATC code: R03AL04
Danish: Farmakoterapeutisk klassifikation: Lægemidler til obstruktive luftvejssygdomme, adrenergika i kombination med antikolinergika, ATC-kode: R03AL04
English: Capsule chamber
Danish: Kapselkammer
English: Concomitant use not recommended
Danish: Samtidig brug ikke anbefalet
English: The safety profile is characterised by typical anticholinergic and beta-adrenergic symptoms related to the individual components of the combination.
Danish: Sikkerhedsprofilen er karakteriseret ved typiske antikolinerge og beta-adrenerge symptomer relateret til de individuelle komponenter i kombinationen.
English: The in vitro human serum and plasma protein binding was about 95%.
Danish: Den humane in vitro serum- og plasmaproteinbinding var ca. 95 %.
English: Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first.
Danish: Inden for hver systemorganklasse er bivirkningerne ordnet efter hyppighed med den hyppigste bivirkning først.
English: If this occurs, treatment should be discontinued immediately and alternative therapy instituted.
Danish: Hvis det opstår, skal behandlingen straks seponeres og erstattes med alternativ behandling.
English: No evidence of carcinogenicity was seen in mice.
Danish: Der var ingen tegn på karcinogenitet hos mus.
English: There were no major differences in total systemic exposure (AUC) between Japanese and Caucasian subjects.
Danish: Der var ingen større forskelle i total systemisk eksponering (AUC) mellem japanere og kaukasiere.
English: Also contains: lactose and magnesium stearate.
Danish: Indeholder også: lactose og magnesiumstearat.
English: In patients with COPD, pharmacokinetic steady-state of glycopyrronium was reached within one week of the start of treatment.
Danish: Hos patienter med KOL blev den farmakokinetiske steady state for glycopyrronium nået inden for en uge efter behandlingsstart.
English: • pain in arms or legs.
Danish: • smerte i arme eller ben.
English: A greater than 4-fold selectivity for the human M3 receptors over the human M2 receptor has been demonstrated using radioligand binding studies.
Danish: Der er påvist en selektivitet på mere end fire gange over for de humane M3-receptorer end over for de humane M2receptorer ved hjælp af forsøg med radioligand binding.
English: • feeling tired or very thirsty, having an increased appetite without gaining weight and passing more urine than usual - these may be signs of high level of sugar in the blood (hyperglycaemia).
Danish: • føle sig træt eller være meget tørstig, øget appetit uden at tage på i vægt og hyppigere vandladning end vanligt - dette kan være tegn på forhøjet blodsukkerniveau (hyperglykæmi).
English: Ask your doctor or pharmacist for advice before using any medicine.
Danish: Spørg din læge eller apoteket til råds, før du tager nogen form for medicin.
English: When compared with the serum clearance of indacaterol of 23.3 litres/hour, it is evident that renal clearance plays a minor role (about 2 to 5% of systemic clearance) in the elimination of systemically available indacaterol.
Danish: Når dette sammenlignes med en serumclearance af indacaterol på 23,3 liter/time, er det klart, at renal clearance spiller en mindre rolle (ca. 2 til 5 % af den systemiske clearance) i forbindelse med eliminering af systemisk tilgængeligt indacaterol.
English: As it contains indacaterol and glycopyrronium, the type and severity of adverse reactions associated with each of these components may be expected in the combination.
Danish: Da det indeholder indacaterol og glycopyrronium, kan typen og sværhedsgraden af bivirkninger, der er forbundet med hver af disse komponenter, forventes i kombinationen.
English: Cleaning the inhaler Wipe the mouthpiece inside and outside with a clean, dry, lint-free cloth to remove any powder residue.
Danish: Rengøring af inhalatoren Tør inderside og yderside af mundstykket med en ren, tør og fnugfri klud for at fjerne eventuelle pulverrester.
English: Check
Danish: Tjek
English: The decrease in serum potassium is usually transient, not requiring supplementation.
Danish: Reduktionen af serumkalium er typisk midlertidig og kræver ikke supplering.
English: Pierce and release
Danish: Perforer og slip
English: OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)
Danish: YDERKARTON TIL MULTIPAKNING (INKLUSIVE BLÅ BOKS)
English: The usual dose is to inhale the content of one capsule each day.
Danish: Den sædvanlige dosis er inhalation af én kapsel dagligt.
English: Indacaterol serum concentrations declined in a multi-phasic manner with an average terminal half-life ranging from 45.5 to 126 hours.
Danish: Serumkoncentrationer af indacaterol faldt på en multifasisk måde med en gennemsnitlig terminal halveringstid på 45,5 til 126 timer.
English: After intravenous infusion the volume of distribution of indacaterol during the terminal elimination phase was 2557 litres indicating an extensive distribution.
Danish: Efter intravenøs infusion var indacaterols fordelingsvolumen under den terminale eliminationsfase 2.557 liter, hvilket indikerer en omfattende distribution.
English: If there is powder left in the capsule:
Danish: Hvis der er overskydende pulver i kapslen:
English: Glycopyrronium bromide (including its metabolites) was excreted into the milk of lactating rats and reached up to 10-fold higher concentrations in the milk than in the blood of the dam.
Danish: Glycopyrroniumbromid (herunder dets metabolitter) blev udskilt i mælken hos diegivende rotter og nåede op til 10 gange større koncentrationer i mælken end i blodet hos moderen.
English: In clinical studies, the amount of indacaterol excreted unchanged via urine was generally lower than 2.5% of the delivered dose.
Danish: I kliniske forsøg var den udskilte mængde uændret indacaterol i urinen generelt lavere end 2,5 % af leveret dosis.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Danish: Non-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: Although beta2-adrenergic receptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1-adrenergic receptors are the predominant receptors in the human heart, there are also beta2-adrenergic receptors in the human heart comprising 10% to 50% of the total adrenergic receptors.
Danish: Selvom beta2-adrenerge receptorer er de fremherskende adrenerge receptorer i den bronkiale glatte muskulatur, og beta1-adrenerge receptorer er de fremherskende receptorer i det humane hjerte, eksisterer der ligeledes beta2-adrenerge receptorer i det humane hjerte, som udgør 10-50 % af den samlede mængde adrenerge receptorer.
English: They have the product code “IGP110.50” printed in blue under two blue bars on the body and the company logo ( ) printed in black on the cap.
Danish: De har produktkoden ”IGP110.50” trykt med blåt under to blå streger på underdelen og virksomhedens logo ( ) trykt i sort på hætten.
English: • difficulty sleeping.
Danish: • søvnproblemer.
English: Repeat steps 3a to 3c.
Danish: Gentag trin 3a til 3c.
English: - you have diabetes.
Danish: - hvis du har sukkersyge.
English: Rare (may affect up to 1 in 1000 people) • tingling or numbness.
Danish: Sjælden (kan forekomme hos op til 1 ud af 1.000 personer) • prikken eller følelsesløshed.
English: Paradoxical bronchospasm
Danish: Paradokse bronkospasmer
English: If you forget to inhale a dose at the usual time, inhale one as soon as possible that day.
Danish: Hvis du har glemt at inhalere en dosis til sædvanlig tid, så inhalér én så hurtigt som muligt samme dag.
English: Never wash your inhaler with water.
Danish: Vask aldrig din inhalator med vand.
English: INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
Danish: DELPAKNING AF MULTIPAKNING (UDEN BLÅ BOKS)
English: • Never place the capsule into your mouth or the mouthpiece of the inhaler.
Danish: • Læg aldrig kapslen direkte i munden eller i inhalatorens mundstykke.
English: Renal elimination of parent drug accounts for about 60 to 70% of total clearance of systemically available glycopyrronium whereas non-renal clearance accounts for about 30 to 40%.
Danish: Renal udskillelse af moderstoffet står for ca. 60 til 70 % af den totale clearance af systemisk tilgængeligt glycopyrronium, mens ikke-renale clearanceprocesser står for ca. 30 til 40 %.
English: • Never wash your inhaler with water.
Danish: • Vask aldrig din inhalator med vand.
English: Other most common adverse reactions related to the medicinal product (at least 3% of patients for Ultibro Breezhaler and also greater than placebo) were cough, nasopharyngitis and headache.
Danish: Øvrige mest almindelige bivirkninger relateret til lægemidlet (mindst 3 % af patienterne på Ultibro Breezhaler og også højere end for placebo) var hoste, nasopfaryngitis og hovedpine.
English: In vitro investigations further indicated that indacaterol is a low affinity substrate for the efflux pump P-gp.
Danish: In vitro-undersøgelser indikerer endvidere, at indacaterol er et substrat med lav affinitet for efflukspumpen P-gp.
English: A negative correlation between systemic exposure and lean body weight (or body weight) was observed; however, no dose adjustment is recommended due to the magnitude of the change or the predictive precision of lean body weight.
Danish: Der sås negativ korrelation mellem systemisk eksponering og fedt-fri legemsvægt (eller legemsvægt), der anbefales dog ikke dosisjustering på baggrund af omfanget af disse ændringer eller den forudsigelige præcision af fedt-fri legemsvægt.
English: Only pierce the capsule once.
Danish: Perforer kun kapslen én gang.
English: The capsules should remain in the blister until you need to use them.
Danish: Kapslerne skal forblive i blisteren, indtil de skal bruges.
English: Insufficient pharmacokinetic data is available for other ethnicities or races.
Danish: Der er ikke tilstrækkelige farmakokinetiske data for andre etniske grupper eller racer.
English: You should hear a noise as the capsule is pierced.
Danish: Du vil høre et klik, når kapslen perforeres.
English: Metabolism and nutrition disorders Hyperglycaemia and diabetes mellitus
Danish: Metabolisme og ernæring Hyperglykæmi og diabetes mellitus
English: This medicine contains two active substances called indacaterol and glycopyrronium.
Danish: Dette lægemiddel indeholder to aktive stoffer, der kaldes indacaterol og glycopyrronium.
English: The in vitro human plasma protein binding of glycopyrronium was 38% to 41% at concentrations of 1 to 10 nanograms/ml.
Danish: In vitro-binding til humant plasmaprotein af glycopyrronium var 38 % til 41 % ved koncentrationer på 1 til 10 nanogram/ml.
English: Glucuronide and/or sulfate conjugates of glycopyrronium were found in urine of humans after repeated inhalation, accounting for about 3% of the delivered dose.
Danish: Glucuronid og/eller sulfatkonjugater af glycopyrronium blev fundet i urin hos mennesker efter gentagen inhalation og udgør ca. 3 % af den leverede dosis.
English: However, as shown in a clinical study in populations with different UGT1A1 genotypes, systemic exposure to indacaterol is not significantly affected by the UGT1A1-genotype.
Danish: Som vist i kliniske studier hos populationer med forskellige UGT1A1-genotyper, er systemisk eksponering af indacaterol dog ikke påvirket signifikant af UGT1A1-genotypen.
English: Post-dose trough FEV1 (least squares mean) at day 1 and week 26 (primary endpoint)
Danish: Postdosis dal-FEV1 (least squares gennemsnit) ved dag 1 og uge 26 (primært endepunkt)
English: Step 1a: Pull off cap
Danish: Trin 1a: Fjern hætten
English: The mean bronchodilator effect derived from serial FEV1 measurements over 24 h was 320 ml after 26 weeks of treatment.
Danish: Den gennemsnitlige bronkodilaterende virkning stammende fra serie FEV1-målinger over 24 timer var 320 ml efter 26 ugers behandling.
English: The presentation of the safety profile is based on the experience with Ultibro Breezhaler and the individual active substances.
Danish: Oplysningerne om sikkerhedsprofilen er baseret på erfaringerne med Ultibro Breezhaler og de individuelle aktive stoffer.
English: Caution required with concomitant use
Danish: Forsigtighed nødvendig ved samtidig brug
English: Disposing of the inhaler after use
Danish: Bortskaffelse af inhalator efter brug
English: Shortening of electrocardiograph intervals and decreased systolic and diastolic blood pressure were also apparent.
Danish: Der var også tydelig afkortning af ekg-intervaller og nedsat systolisk og diastolisk blodtryk.
English: Inhale medicine deeply Hold the inhaler as shown in the picture.
Danish: Inhaler medicinen dybt Hold inhalatoren som vist på billedet.
English: Therefore Ultibro Breezhaler should not be given together with beta-adrenergic blockers (including eye drops) unless there are compelling reasons for their use.
Danish: Ultibro Breezhaler bør derfor ikke gives sammen med beta-adrenerge blokkere (herunder øjendråber), medmindre der er tvingende årsager hertil.
English: If you feel dizzy while taking this medicine, do not drive or use machines.
Danish: Hvis du føler dig svimmel under behandlingen med dette lægemiddel, må du ikke køre bil eller betjene maskiner.
English: Use of cardioselective beta blockers may be considered for treating beta2adrenergic effects, but only under the supervision of a physician and with extreme caution since the use of beta-adrenergic blockers may provoke bronchospasm.
Danish: Brug af kardioselektive betablokkere kan overvejes til at behandle beta2-adrenerge virkninger, men kun under overvågning af en læge og med ekstrem forsigtighed, da brugen af beta-adrenerge blokkere kan udløse bronkospasme.
English: After oral administration of radiolabelled indacaterol in a human ADME (absorption, distribution, metabolism, excretion) study, unchanged indacaterol was the main component in serum, accounting for about one third of total drug-related AUC over 24 hours.
Danish: Efter oral administration af radioaktivt mærket indacaterol i et humant ADME-forsøg (absorption, distribution, metabolisme, ekskretion), var indacaterol som uændret form den primære komponent i serum og udgjorde ca. en tredjedel af det samlede lægemiddelrelaterede AUC over 24 timer.
English: Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
Danish: Tag ikke lægemidlet, hvis pakningen er beskadiget eller viser tegn på at have været åbnet.
English: The recommended dose is the inhalation of the content of one capsule once daily using the Ultibro Breezhaler inhaler.
Danish: Den anbefalede dosis er inhalation af indholdet i en kapsel én gang dagligt ved hjælp af Ultibro Breezhaler-inhalatoren.
English: Adverse reactions detected during clinical trials and from post-marketing sources are listed by MedDRA system organ class (Table 1).
Danish: Bivirkninger set i kliniske studier og efter markedsføringen er angivet i henhold til MedDRAsystemorganklasserne (Tabel 1).
English: • diarrhoea or stomach ache.
Danish: • diarré eller mavepine.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter faldende alvorlighed.
English: Glycopyrronium was not teratogenic in rats or rabbits following inhalation administration.
Danish: Glycopyrronium var ikke teratogent hos rotter eller kaniner efter inhalationsadministration.
English: Therefore, long-acting beta2-adrenergic agonists should be used with caution in patients with known or suspected prolongation of the QT interval or treated with medicinal products affecting the QT interval.
Danish: Langtidsvirkende beta2-adrenerge agonister bør derfor anvendes med forsigtighed hos patienter med kendt eller mistænkt forlængelse af QT-intervallet, eller som behandles med lægemidler, der kan påvirke QT-intervallet.
English: The effect was significantly greater for Ultibro Breezhaler, when compared to indacaterol, glycopyrronium or tiotropium alone (difference 110 ml, for each comparison).
Danish: Virkningen var signifikant højere for Ultibro Breezhaler sammenlignet med indacaterol, glycopyrronium eller tiotropium alene (forskel på 110 ml for hver sammenligning).
English: Talk to your doctor, pharmacist or nurse before using Ultibro Breezhaler if any of the following applies to you: - you have asthma - this medicine should not be used as a treatment for asthma.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Ultibro Breezhaler hvis noget af følgende passer på dig: - hvis du har astma - denne medicin må ikke bruges til behandling af astma.
English: Following inhalation of Ultibro Breezhaler, the absolute bioavailability of indacaterol has been estimated to range from 61 to 85% of the delivered dose, and that of glycopyrronium was about 47% of the delivered dose.
Danish: Efter inhalation af Ultibro Breezhaler er den absolutte biotilgængelighed af indacaterol blevet estimeret til at være fra 61 til 85 % af leveret dosis, og for glycopyrronium var den omkring 47 % af leveret dosis.
English: Based on the magnitude of these changes, no clinically relevant drug interaction is expected when glycopyrronium is co-administered with cimetidine or other inhibitors of the organic cation transport.
Danish: På baggrund af disse ændringers omfang forventes der ingen klinisk relevant lægemiddelinteraktion, når glycopyrronium administreres sammen med cimetidin eller andre hæmmere af organisk kationtransport.
English: Remove capsule Separate one of the blisters from the blister card.
Danish: Fjern kapslen Adskil en blister fra blisterkortet.