FrancophonIA/ELRC3.0 huggingface dataset:
English: Volume of post-authorisation procedures finalised for human medicines increased by 13%
Danish: Antallet af afsluttede procedurer efter godkendelse for humanmedicinske lægemidler steg med
English: an anti-rheumatic biological agent (interleukin-6 receptor antagonist) that can be used in combination with methotrexate to treat adults with moderate to severe active rheumatoid arthritis (an immune disease causing inflammation of the joints).
Danish: et lægemiddel til behandling af hyperfenylalaninæmi (høje niveauer af phenylalanin i blodet) hos patienter med den genetiske sygdom fenylketonuri eller tetrahydrobiopterinmangel et nyt stof i en eksisterende klasse af antiretrovirale lægemidler, der kan bruges til behandling af voksne inficeret med hiv-1 (det virus, der forårsager aids), hos hvem behandling med andre lægemidler i samme klasse er slået fejl en antireumatisk biologisk agens (interleukin-6-receptorantagonist), som kan anvendes i kombination med methotrexat til behandling af voksne med moderat til alvorlig aktiv reumatoid artritis (en immunlidelse, der forårsager hævelse af leddene).
English: Volume of post-authorisation procedures initiated for human medicines increased by 10%
Danish: Antallet af indledte procedurer efter godkendelse for humanmedicinske lægemidler steg med
English: Assessing applications for orphan designation
Danish: Vurdering af ansøgninger om udpegelse af lægemidler til sjældne sygdomme
English: Positive opinions Negative opinions Application withdrawals
Danish: Negative udtalelser
English: Type-I variations Type-II variations Extensions
Danish: Type-II ændringer
English: If this happens, try again.
Danish: Hvis dette sker, så prøv igen.
English: It will also help you to remember to use it.
Danish: Det vil også hjælpe dig med at huske at bruge den.
English: Throw away the bag.
Danish: Smid posen ud.
English: Preferred term Frequency
Danish: Foretrukket term Hyppighed
English: Percentage of Patients who achieved MCID
Danish: Procentdel af patienter, som opnåede MCID
English: 1.0 unit
Danish: 1,0 enhed
English: Some patients may not hear the ‘click'.
Danish: Nogle patienter hører måske ikke 'klikket'.
English: Stop and Check:
Danish: Stop og kontroller:
English: Date of first authorisation: 20 July 2012 Date of last renewal: 20 April 2017
Danish: Dato for første markedsføringstilladelse: 20. juli 2012 Dato for seneste fornyelse: 20. april 2017
English: This ensures that there is always enough medicine in your body to help you breathe more easily throughout the day and night.
Danish: Det garanterer, at der altid er tilstrækkelig medicin i din krop til at hjælpe dig med at trække vejret lettere hele dagen og natten.
English: Deterioration of disease:
Danish: Forværring af sygdom:
English: 70.7% of patients completed the study per investigator assessment.
Danish: 70,7 % af patienterne fuldførte studiet ifølge investigators vurdering.
English: Allergic reactions may rarely occur (may affect up to 1 in 1,000 people).
Danish: Allergiske reaktioner kan forekomme i sjældne tilfælde (kan påvirke op til 1 ud af 1.000 personer).
English: Keep breathing in as long as possible after you hear the ‘click'.
Danish: Bliv ved med at indånde så længe som muligt, efter du har hørt 'klikket'.
English: How does the dose indicator work?
Danish: Hvordan fungerer dosisindikatoren?
English: What should you do if you accidently prepare a dose?
Danish: Hvad skal du gøre, hvis du ved en fejl kommer til at forberede en dosis?
English: Please contact your doctor if the control window is still green after repeated attempts.
Danish: Kontakt din læge, hvis kontrolvinduet stadigvæk er grønt efter gentagne forsøg.
English: Do not take an extra dose even if you do not taste or feel anything after inhaling.
Danish: Tag ikke en ekstra dosis, selv ikke hvis du ikke smager eller føler noget efter inhalationen.
English: When you press the button all the way down, the control window changes from red to green.
Danish: Når du trykker knappen helt ned, skifter kontrolvinduet fra rødt til grønt.
English: The dose is not prepared.
Danish: Dosis er ikke forberedt.
English: A risk to newborns/infants cannot be excluded.
Danish: Det kan ikke udelukkes, at der er en risiko for nyfødte/spædbørn.
English: Before use:
Danish: Før brug:
English: Control window Red = confirms correct inhalation
Danish: Kontrolvindue Rødt = bekræfter korrekt inhalation
English: Improvement over placebo p-value
Danish: Forbedring over placebo p-værdi
English: Anaphylactic reaction Not known
Danish: Ikke kendt Anafylaktisk reaktion Ikke kendt
English: Read steps 2.1 to 2.7 fully before use.
Danish: Læs punkt 2.1 - 2.7 igennem før brug.
English: 30 doses 60 doses
Danish: 30 doser 60 doser
English: Aclidinium bromide should only be used during pregnancy if the expected benefits outweigh the potential risks.
Danish: Aclidiniumbromid bør kun anvendes under graviditet, når de forventede fordele opvejer de potentielle risici.
English: Dose indicator moves slowly from 60 to 0: 60, 50, 40, 30, 20, 10, 0.
Danish: Dosisindikator flytter langsomt fra 60 til 0: 60, 50, 40, 30, 20, 10, 0.
English: You can use Bretaris Genuair any time before or after food or drink.
Danish: Du kan bruge Bretaris Genuair på ethvert tidspunkt før eller efter indtagelse af mad eller drikke.
English: The Instructions for Use is divided into the following sections:
Danish: Brugsanvisningen er inddelt i følgende afsnit:
English: b) Do not press the green button until you are ready to take a dose.
Danish: b) Tryk ikke på den grønne knap, før du er klar til at tage en dosis.
English: Pregnancy There are no data available on the use of aclidinium bromide in pregnant women.
Danish: Graviditet Der er ingen data for anvendelse af aclidiniumbromid hos gravide kvinder.
English: If the control window still does not change to red, you may have forgotten to release the green button before inhaling, or you may not have inhaled strongly enough.
Danish: Hvis kontrolvinduet stadigvæk ikke er skiftet til rødt, har du måske glemt at slippe den grønne knap før inhalation, eller du har måske ikke inhaleret kraftigt nok.
English: Do not use this medicine after the expiry date which is stated on the inhaler label and carton after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på inhalatorens etiket og karton efter "EXP".
English: How do you know that your inhaler is empty?
Danish: Hvordan ved du, at din inhalator er tom?
English: A ‘click' will let you know that you are inhaling correctly.
Danish: Et 'klik' lader dig vide, at du inhalerer korrekt.
English: NEVER use water to clean the inhaler, as this may damage your medicine.
Danish: Brug ALDRIG vand til at rengøre inhalatoren, da det kan ødelægge medicinen.
English: These conditions may be affected by the anticholinergic mechanism of action.
Danish: Disse tilstande kan påvirkes af den antikolinerge virkningsmekanisme.
English: Keep breathing in for as long as possible.
Danish: Bliv ved med at indånde så længe som muligt.
English: The rate of moderate or severe COPD exacerbations per patient per year during the first year of treatment was evaluated as the primary efficacy endpoint in the study.
Danish: Antallet af moderate eller svære KOL-eksacerbationer pr. patient pr. år i løbet af behandlingens første år blev evalueret som det primære effektendepunkt i studiet.
English: Some patients may experience a grainy sensation in their mouth, or a slightly sweet or bitter taste.
Danish: Nogle patienter kan opleve en grynet fornemmelse i munden, eller en svag sød eller bitter smag.
English: c Odds ratio, increase in the likelihood of achieving the MCID compared to placebo.
Danish: c Odds-ratio, stigning i sandsynligheden for at opnå MCID sammenlignet med placebo.
English: The study had an event-driven design and was terminated once sufficient MACE events for the primary safety analysis were observed.
Danish: Studiet havde et hændelsesdrevet design og blev afsluttet, da der blev observeret tilstrækkeligt med MACE-hændelser til den primære sikkerhedsanalyse.
English: After that, the inhaler cannot be used again and you should start using a new inhaler.
Danish: Herefter kan inhalatoren ikke anvendes mere, og du skal begynde at bruge en ny inhalator.
English: 59.8% of patients had at least one COPD exacerbation within the past 12 months from the screening visit.
Danish: 59,8 % af patienterne havde haft mindst én KOL-eksacerbation inden for de seneste 12 måneder efter screeningsbesøget.
English: The use of Bretaris Genuair with these medicines is not recommended.
Danish: Brug af Bretaris Genuair med disse lægemidler anbefales ikke.
English: 2.5 Hold your breath for as long as possible.
Danish: 2.5 Hold vejret så længe som muligt.
English: Use the control window to ensure you have inhaled correctly.
Danish: Brug kontrolvinduet for at sikre dig, at du har inhaleret korrekt.
English: b MCID of at least - 4 units change in SGRQ.
Danish: b MCID på mindst - 4 enheders ændring i SGRQ.
English: • Each time you load a dose by pressing the green button, the dose indicator moves by a small amount towards the next number (50, 40, 30, 20, 10, or 0).
Danish: • Hver gang du klargør en dosis ved at trykke på den grønne knap, flytter dosisindikatoren sig et lille stykke mod det næste tal (50, 40, 30, 20, 10 eller 0).
English: It is supplied in a plastic pouch.
Danish: Den leveres i en plastikpose.
English: Never breathe out into the inhaler (Figure I).
Danish: Ånd aldrig ud gennem inhalatoren (Figur I).
English: It is important to instruct the patients to carefully read the Instructions for Use in the Package Leaflet, which is packed together with each inhaler.
Danish: Det er vigtigt at instruere patienten i nøje at læse brugsanvisningen i indlægssedlen, som er pakket sammen med hver inhalator.
English: Up to 65% of the dose was eliminated as metabolites in the urine and up to 33% as metabolites in the faeces.
Danish: Op til 65 % af dosen blev elimineret som metabolitter i urinen og op til 33 % som metabolitter i afføringen.
English: The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: Hyppigheden af bivirkninger defineres i henhold til 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: When the green button will not return to its full upper position and is locked in a middle position, you have reached the last dose (Figure O).
Danish: Når den grønne knap ikke returnerer helt til udgangspositionen og er låst i en midterposition, har du nået den sidste dosis (Figur O).
English: • On first use, every inhaler contains at least 60 doses, or at least 30 doses, depending on the pack size.
Danish: • Ved første anvendelse, indeholder hver inhalator mindst 60 doser eller 30 doser, afhængig af pakningsstørrelse.
English: Do not hold the green button down while inhaling.
Danish: Hold ikke den grønne knap nede mens du inhalerer.
English: Push the protective cap back onto the mouthpiece after each use (Figure M), to prevent contamination of the inhaler with dust or other materials.
Danish: Sæt beskyttelseshætten tilbage på mundstykket efter hver brug (Figur M), for at forhindre forurening af inhalatoren med støv eller andre ting.
English: Your medicine is ready to be inhaled.
Danish: Din medicin er nu klar til at blive inhaleret.
English: Also contains: Lactose
Danish: Indeholder også: Lactose
English: Getting Started
Danish: Før opstart
English: You should get a new inhaler:
Danish: Du bør anskaffe en ny inhalator:
English: 2.2 Hold your head upright, put the mouthpiece between your lips, and close your lips tightly around it (Figure J).
Danish: 2.2 Hold dit hoved oprejst, sæt mundstykket mellem dine læber og luk læberne tæt omkring det (Figur J).
English: Then take a strong, deep breath through the mouthpiece.
Danish: Tag derefter en kraftig, dyb indånding gennem mundstykket.
English: Paradoxical bronchospasm:
Danish: Paradoks bronkospasme:
English: Inform your doctor if you have been or are using similar medicines for breathing problems, such as medicines containing tiotropium, ipratropium.
Danish: Fortæl lægen, hvis du har taget eller aktuelt tager andre lignende lægemidler for vejrtrækningsproblemer, såsom lægemidler, der indeholder tiotropium, ipratropium.
English: - 4.6 units a Minimum clinically important difference (MCID) of at least 1 unit change in TDI.
Danish: - 4,6 enheder a Minimum klinisk betydelig forskel (MCID) på mindst 1 enheds ændring i TDI.
English: When should you get a new inhaler?
Danish: Hvornår bør du anskaffe en ny inhalator?
English: All patients had a history of cardiovascular or cerebrovascular disease and/or significant cardiovascular risk factors.
Danish: Alle patienter havde kardiovaskulær eller cerebrovaskulær sygdom i anamnesen og/eller signifikante kardiovaskulære risikofaktorer.
English: The recommended dose can be used for elderly patients and for patients with kidney or liver problems.
Danish: Den anbefalede dosis kan anvendes til ældre patienter og til patienter med nedsat nyre- eller leverfunktion.
English: Steady-state plasma levels were attained within seven days of twice daily dosing.
Danish: Steady-state plasmaniveauer blev nået inden for syv dage ved dosering to gange dagligt.
English: Aclidinium bromide is a competitive, selective muscarinic receptor antagonist (also known as an anticholinergic), with a longer residence time at the M3 receptors than the M2 receptors.
Danish: Aclidiniumbromid er en kompetitiv, selektiv muskarin receptor-antagonist (også kendt som et anticholinergikum) med en længere opholdstid ved M3-receptorerne end M2-receptorerne.
English: If you forget a dose of Bretaris Genuair, inhale the dose as soon as you remember.
Danish: Hvis du glemmer en dosis af Bretaris Genuair, skal du inhalere dosen, så snart du husker det.
English: In the event of a change in COPD intensity while the patient is being treated with aclidinium bromide so that the patient considers additional rescue medication is required, a re-evaluation of the patient and the patients' treatment regimen should be conducted.
Danish: Hvis der er en ændring i intensiteten af KOL, mens patienten behandles med aclidiniumbromid, og patienten mener, at yderligere anfaldsbehandling er nødvendig, skal patienten og patientens behandlingsregimen revurderes.
English: If you are affected by any of these side effects do not drive or use machinery until the headache has cleared, the feeling of dizziness has passed and your vision has returned to normal.
Danish: Hvis du er påvirket af nogen af disse bivirkninger, må du ikke føre motorkøretøjer eller betjene maskiner, før hovedpinen eller fornemmelsen af svimmelhed er gået væk, og dit syn er blevet normalt igen.
English: High doses of aclidinium bromide may lead to anticholinergic signs and symptoms.
Danish: Høje doser af aclidiniumbromid kan føre til antikolinerge tegn og symptomer.
English: The upper bound of the confidence interval excluded a pre-defined risk margin of 1.8.
Danish: Den øvre grænse for konfidensintervallet udelukkede en prædefineret risikomargen på
English: After you have taken the last dose, the inhaler has to be disposed of.
Danish: Når du har taget den sidste dosis, skal inhalatoren bortskaffes.
English: Patients discontinued treatment if they experienced a MACE event and entered into the post-treatment follow-up period during the study.
Danish: Patienterne seponerede behandlingen, hvis de fik en MACE-hændelse og overgik efter behandling til studiets opfølgningsperiode.
English: The recommended dose is one inhalation twice a day in the morning and evening.
Danish: Den anbefalede dosis er én inhalation to gange dagligt, morgen og aften.
English: It is important that you read this information as the Genuair may work differently from inhalers you have used previously.
Danish: Det er vigtigt, at du læser denne information, da Genuair måske fungerer anderledes end inhalatorer, som du har brugt tidligere.
English: Children and adolescents Bretaris Genuair is not for use in children or adolescents below 18 years of age.
Danish: Børn og unge Bretaris Genuair er ikke beregnet til brug hos børn eller unge under 18 år.
English: These may be signs of a condition called bronchospasm.
Danish: Dette kan være tegn på en tilstand betegnet bronkospasme.
English: Similar observations were made with Bretaris Genuair in the 3 month study.
Danish: Lignende observationer blev set med Bretaris Genuair i 3-månedersstudiet.
English: The frequency of patients with at least one MACE was 3.85% vs. 4.23% patients in the aclidinium and placebo groups, respectively.
Danish: Frekvensen af patienter med mindst én MACE var 3,85 % versus 4,23 % patienter i henholdsvis aclidinium- og placebogruppen.
English: Administration of Bretaris Genuair may cause paradoxical bronchospasm.
Danish: Administration af Bretaris Genuair kan medføre paradoks bronkospasme.
English: Biotransformation via CYP450 enzymes plays a minor role in the total metabolic clearance of aclidinium bromide.
Danish: Biotransformation via CYP450-enzymer spiller en mindre rolle i den samlede metaboliske clearance af aclidiniumbromid.
English: This means you have not inhaled your medicine correctly.
Danish: Det betyder, at du ikke har inhaleret din medicin korrekt.
English: Maximal bronchodilatory effects were evident from day one and were maintained over the 6-month treatment period.
Danish: Maksimal bronkodilatatorisk effekt opnåedes fra dag 1 og blev opretholdt over behandlingsperioden på 6 måneder.
English: STEP 1: Prepare your dose
Danish: PUNKT 1: Forbered din dosis
English: The safety margins for human systemic exposure with 400 µg twice daily over the no observed adverse effect levels in these studies ranged from 7- to 73-fold.
Danish: Sikkerhedsmargenerne for human systemisk eksponering i disse forsøg ved 400 µg to gange dagligt over "no observed adverse effect"-niveauerne strakte sig fra 7 til 73 gange.
English: This section contains information on how to use your Genuair inhaler.
Danish: Dette afsnit indeholder information om, hvordan du skal anvende din Genuair inhalator.
English: How should you clean the inhaler?
Danish: Hvordan skal du rengøre din inhalator?
English: It is considered unlikely that aclidinium bromide administered at the recommended dose will affect fertility in humans.
Danish: Det betragtes som usandsynligt, at aclidiniumbromid indgivet ved den anbefalede dosis vil påvirke fertiliteten hos mennesker.
English: 1.87-fold c increase in likelihood
Danish: 1,87-gang forøgelse af sandsynlighed
English: - Getting started - Step 1: Prepare your dose - Step 2: Inhale your medicine - Additional information
Danish: - Før opstart - Punkt 1: Forbered din dosis - Punkt 2: Inhalér din medicin - Yderligere information
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, anticholinergics; ATC Code: R03BB05.
Danish: Farmakoterapeutisk klassifikation: Lægemidler mod obstruktiv lungesygdom, antikolinergika; ATCkode: R03BB05.
English: If you wish to clean your inhaler, just wipe the outside of the mouthpiece with a dry tissue or paper towel.
Danish: Hvis du ønsker at rengøre din inhalator, skal du bare tørre ydersiden af mundstykket af med et tørt stykke køkkenrulle eller papirlommetørklæde.
English: Cardiovascular effects:
Danish: Kardiovaskulære virkninger:
English: • If your inhaler appears to be damaged or if you lose the cap, or
Danish: • hvis din inhalator ser ud at at være beskadiget, eller hvis du har mistet beskyttelseshætten, eller
English: • If your inhaler is empty (Figure O).
Danish: • hvis din inhalator er tom (Figur O).
English: If a dose is missed the next dose should be taken as soon as possible.
Danish: Hvis en dosis springes over, skal den næste dosis tages hurtigst muligt.
English: - if you have an enlarged prostate, problems passing urine, or a blockage in your bladder.
Danish: - hvis du har en forstørret prostata, problemer med vandladning eller blokering i blæren.
English: The hydrolysis occurs both chemically (non-enzymatically) and enzymatically by esterases, butyrylcholinesterase being the main human esterase involved in the hydrolysis.
Danish: Hydrolysen forekommer både kemisk (ikke-enzymatisk) og enzymatisk ved esteraser, hvor butyrylcholinesterase er den primære humane esterase involveret i hydrolysen.
English: • The dose indicator shows the total number of doses left in the inhaler (Figure N).
Danish: • Dosisindikatoren viser det totale antal af doser der er tilbage i inhalatoren (Figur N).
English: Do not use the Bretaris Genuair if you notice that the pack is damaged or shows signs of tampering.
Danish: Brug ikke Bretaris Genuair, hvis du bemærker, at pakningen er beskadiget, eller der er synlige tegn på manipulering.
English: Even though the green button is locked, your last dose may still be inhaled.
Danish: Selvom den grønne knap er låst, kan du stadigvæk inhalere den sidste dosis.
English: If this occurs, treatment with Bretaris Genuair should be stopped and other treatments considered.
Danish: Hvis dette sker, skal behandling med Bretaris Genuair stoppes og andre behandlinger overvejes.
English: The fraction of the inhaled dose that reaches the systemic circulation as unchanged aclidinium is very low at less than 5%.
Danish: Den brøkdel af den inhalerede dosis, der når systemkredsløbet som uændret aclidinium er meget lav, under 5 %.
English: Talk to your doctor, pharmacist or nurse before using Bretaris Genuair: - if you have had heart problems recently.
Danish: Kontakt lægen, apotekspersonalet eller sygeplejersken, før du bruger Bretaris Genuair: - hvis du for nylig har haft hjerteproblemer.
English: 1.68-fold c increase in likelihood
Danish: 1,68-gang forøgelse af sandsynlighed
English: The Bretaris Genuair group showed a statistically significant delay in the time to first moderate or severe exacerbation while on-treatment compared to the placebo group.
Danish: Bretaris Genuair-gruppen udviste en statistisk signifikant forsinkelse i tiden til første moderate eller svære eksacerbation under behandlingen sammenlignet med placebogruppen.
English: If your COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse you should contact your doctor for advice as soon as possible.
Danish: Hvis dine KOL-symptomer (åndenød, hvæsen, hoste) ikke bliver bedre, eller hvis de bliver værre, skal du snarest muligt spørge din læge til råds.
English: The inhaler device is a multicomponent device made of polycarbonate, acrylonitrile-butadiene-styrene, polyoxymethylene, polyester-butylene-terephthalate, polypropylene, polystyrene and stainless steel.
Danish: Inhalatoranordningen er en anordning med flere komponenter, der er fremstillet af polycarbonat, acrylonitril-butadien-styren, polyoxymethylen, polyesterbutylenterephthalat, polypropylen, polystyren og rustfrit stål.
English: The pharmacokinetic properties of aclidinium bromide in patients with moderate to severe COPD appear to be similar in patients aged 40-59 years and in patients aged ≥70 years.
Danish: De farmakokinetiske egenskaber af aclidiniumbromid hos patienter med moderat til svær KOL lader til at være sammenlignelige hos patienter i alderen 40-59 år og hos patienter ≥70 år.
English: If you want to stop treatment, first talk to your doctor, as your symptoms may worsen.
Danish: Tal med din læge inden, hvis du ønsker at stoppe behandlingen, da dine symptomer kan blive værre.
English: - The other ingredient is lactose monohydrate (refer to Section 2 “Bretaris Genuair contains lactose”).
Danish: - Øvrige indholdsstoffer: lactosemonohydrat (se punkt 2 "Bretaris Genuair indeholder lactose").
English: This means you have inhaled your medicine correctly.
Danish: Dette betyder, at du har inhaleret din medicin korrekt.
English: 2.1 Hold the inhaler away from your mouth, and breathe out completely.
Danish: 2.1 Hold inhalatoren væk fra munden og pust helt ud.