FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use Bretaris Genuair - if you are allergic to aclidinium bromide or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Bretaris Genuair - hvis du er allergisk over for aclidiniumbromid eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: The mouthpiece is covered with a removable green protective cap.
Danish: Mundstykket er dækket med en aftagelig grøn beskyttelseshætte.
English: Regular use of Bretaris Genuair can help you when you have ongoing shortness of breath related to your disease to help you minimise the effects of the disease on your everyday life and reduce the number of flare-ups (the worsening of your COPD symptoms for several days).
Danish: Regelmæssig brug af Bretaris Genuair kan hjælpe dig, når du oplever vedvarende åndenød relateret til din sygdom, ved at minimere sygdommens påvirkning af din hverdag og reducere antallet af opblusninger (forværring af dine KOL-symptomer i flere dage).
English: This medicine may cause headache, dizziness or blurred vision.
Danish: Lægemidlet kan forårsage hovedpine, svimmelhed eller sløret syn.
English: This makes it easier for chronic obstructive pulmonary disease (COPD) patients to breathe.
Danish: Det gør det lettere for patienter med kronisk obstruktiv lungesygdom (KOL) at trække vejret.
English: 2.3 Take a strong, deep breath through your mouth.
Danish: 2.3 Tag en kraftig, dyb indånding gennem munden.
English: Patients should be instructed on how to administer the product correctly as the Genuair inhaler may work differently from inhalers the patients may have used previously.
Danish: Patienter skal instrueres i, hvordan præparatet administreres korrekt, da Genuair inhalator kan fungere forskelligt fra inhalatorer, som patienten måske har anvendt tidligere.
English: The primary safety endpoint was the time to first occurrence of MACE, defined as any of the following adjudicated events: cardiovascular death, non-fatal myocardial infarction (MI), or non-fatal ischemic stroke.
Danish: Det primære sikkerhedsendepunkt var tiden til første forekomst af MACE, defineret som hvilken som helst af følgende hændelser, der blev betragtet som relateret til behandlingen: kardiovaskulær død, ikke-dødeligt myokardieinfarkt (MI) eller ikke-dødeligt iskæmisk apopleksi.
English: You should not use Bretaris Genuair if you are pregnant or are breast-feeding unless your doctor tells you so.
Danish: Du må ikke tage Bretaris Genuair, hvis du er gravid eller ammer, medmindre din læge fortæller dig, at du skal gøre det.
English: Submission of the results of the agreed post-authorisation safety study (PASS) for aclidinium bromide to evaluate the overall mortality and the proposed cardiovascular safety endpoints (with an additional endpoint of cardiac arrhythmia) among patients with COPD using aclidinium, according to a protocol agreed by the PRAC.
Danish: Fremsendelse af resultaterne af det aftalte sikkerhedsstudie efter tilladelse til markedsføring (PASS) for aclidiniumbromid til evaluering af den totale mortalitet og de foreslåede kardiovaskulære sikkerhedsendepunkter (med yderligere et endepunkt for kardiel arytmi) blandt patienter med KOL, der bruger aclidinium, i henhold til en protokol accepteret af PRAC.
English: Plasma levels of the acid metabolite are approximately 100-fold greater than those of the alcohol metabolite and the unchanged active substance following inhalation.
Danish: Plasmaniveauer af syremetabolitten er cirka 100 gange højere end for alkoholmetabolitten og det uændrede aktive stof efter inhalation.
English: Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and 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, karcinogent potentiale samt reproduktions- og udviklingstoksicitet.
English: Bronchodilators relax airways and help keep bronchioles open.
Danish: Bronkodilatorer afspænder luftvejene og holder bronchiolerne åbne.
English: Aclidinium bromide is quickly broken down in plasma, the level of systemic anticholinergic side effects is therefore low.
Danish: Aclidiniumbromid nedbrydes hurtigt i plasma; niveauet af systemiske antikolinerge bivirkninger er derfor lavt.
English: The low absolute bioavailability of inhaled aclidinium bromide (<5%) is because aclidinium bromide undergoes extensive systemic and pre-systemic hydrolysis whether deposited in the lung or swallowed.
Danish: Den lave absolutte biotilgængelighed af inhaleret aclidiniumbromid (<5 %) skyldes, at aclidiniumbromid gennemgår omfattende systemisk og præsystemisk hydrolisering, uanset om det deponeres i lungerne eller synkes
English: Go back to ‘STEP 2 Inhale your medicine' and repeat steps 2.1 to 2.7.
Danish: Gå tilbage til 'PUNKT 2 Inhalér din medicin' og gentag punkt 2.1 - 2.7.
English: 08740 Sant Andreu de la Barca, Barcelona Spain
Danish: 08740 Sant Andreu de la Barca, Barcelona Spanien
English: Store your inhaler with the protective cap in place until it is time to inhale your medicine, then remove the cap and start at Step 1.6.
Danish: Opbevar din inhalator med beskyttelseshætten på, indtil det er tid til, at du skal inhalere din medicin, tag så beskyttelseshætten af og begynd ved punkt 1.6.
English: The main plasma protein that binds aclidinium bromide is albumin.
Danish: Det primære plasmaprotein, som binder aclidiniumbromid, er albumin.
English: Steady state peak plasma concentrations achieved after dry powder inhalation by COPD patients of 400 µg aclidinium bromide were approximately 224 pg/mL.
Danish: Steady-state peak plasmakoncentration opnået efter tørpulver-inhalation af 400 µg aclidiniumbromid af patienter med KOL var cirka 224 pg/ml.
English: Read these Instructions for Use before you start using the medicine.
Danish: Læs denne brugsanvisning, før du begynder at bruge medicinen.
English: Make sure you release the button so the inhaler can work correctly.
Danish: Du skal sikre dig, at du slipper knappen, så din inhalator fungerer korrekt.
English: Ask your doctor or pharmacist if you are not sure.
Danish: Spørg din læge eller på apoteket, hvis du ikke er sikker.
English: Make sure you have released the green button, and you have breathed out completely.
Danish: Du skal sikre dig, at du har sluppet den grønne knap, og at du har åndet helt ud.
English: Co-administration of aclidinium bromide with other anticholinergic-containing medicinal products has not been studied and is not recommended.
Danish: Samtidig administration af aclidiniumbromid med andre lægemidler, der indeholder antikolinerge stoffer, er ikke blevet undersøgt og anbefales ikke.
English: Following repeated inhalations, the systemic exposure of aclidinium bromide has been observed to be similar in Japanese and Caucasian patients.
Danish: Det er observeret, at den systemiske eksponering af aclidiniumbromid efter gentagne inhalationer er ens hos japanske og kaukasiske patienter.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Bretaris Genuair therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med Bretaris Genuair seponeres/undgås, idet der tages højde for fordelene for barnet ved amning og de terapeutiske fordele for moderen.
English: Become familiar with the parts of your Genuair inhaler.
Danish: Lær delene i din Genuair inhalator at kende.
English: Exercise tolerance
Danish: Tolerance ved motion
English: The terminal elimination half-life and effective half-life of aclidinium bromide are approximately 14 hours and 10 hours, respectively, following inhalation of twice daily 400 µg doses in COPD patients.
Danish: Den terminale eliminationshalveringstid og effektive halveringstid for aclidiniumbromid er henholdsvis ca. 14 timer og 10 timer efter inhalation af to daglige doser på 400 µg til KOL-patienter.
English: No studies have been performed on hepatically-impaired patients.
Danish: Ingen studier er blevet udført med patienter med nedsat leverfunktion.
English: c) Pull off the cap by lightly squeezing the arrows marked on each side (Figure B).
Danish: c) Træk hætten af ved at trykke let på de markerede pile på hver side (Figur B).
English: 2.4 Take the inhaler out of your mouth.
Danish: 2.4 Tag inhalatoren ud af munden.
English: Bretaris Genuair also improved daily symptoms of COPD (dyspnoea, cough and sputum production) and night-time and early morning symptoms.
Danish: Bretaris Genuair forbedrede også daglige symptomer på KOL (dyspnø, hoste og spytproduktion) samt symptomer om natten og tidligt om morgenen.
English: In the long-term safety studies, Bretaris Genuair was associated with bronchodilatory efficacy when administered over a 1-year treatment period.
Danish: I de langvarige sikkerhedsstudier var Bretaris Genuair forbundet med bronkodilatorisk virkning ved indgivelse over en behandlingsperiode på 1 år.
English: The MAH shall complete, within the stated timeframe, the below measures:
Danish: Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme gennemføre nedenstående foranstaltninger:
English: 58.7% were male and 90.7% were Caucasian, with a mean postbronchodilator FEV1 of 47.9% of predicted value and a mean CAT (COPD Assessment Test) of 20.7.
Danish: 58,7 % var mænd, og 90,7 % var kaukasiere, med en middel-FEV1 efter bronkodilatator på 47,9 % af den forventede værdi og middel-CAT (KOL-vurderingstest) på 20,7.
English: Excipients with known effect Each delivered dose contains approximately 12 mg lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver afgivet dosis indeholder cirka 12 mg lactose (som monohydrat).
English: Because aclidinium bromide acts locally in the lungs and is quickly broken down in plasma there is no direct relationship between pharmacokinetics and pharmacodynamics.
Danish: Da aclidiniumbromid virker lokalt i lungerne og hurtigt nedbrydes i plasma, er der ikke noget direkte forhold mellem farmakokinetik og farmakodynamik.
English: Stop using the medicine and contact your doctor immediately if you develop swelling of your face, throat, lips or tongue (with or without difficulty breathing or swallowing), dizziness or fainting, faster heart rate or if you get raised severely itchy bumps on your skin (hives) as these may be symptoms of an allergic reaction.
Danish: Hold op med at tage lægemidlet og kontakt straks din læge, hvis du udvikler hævelse i ansigt, hals, læber eller tunge (med eller uden vejrtræknings- eller synkebesvær), svimmelhed eller besvimelse, hurtigere hjerterytme, eller hvis du får hævede, meget kløende knopper på huden (nældefeber), da det kan være symptomer på en allergisk reaktion.
English: Bretaris Genuair is a dry powder inhaler that uses your breath to deliver the medicine directly into your lungs.
Danish: Bretaris Genuair er en tørpulverinhalator, som bruger dit åndedræt til at levere medicinen direkte til lungerne.
English: The Table below shows symptom relief obtained after 6 months treatment with Bretaris Genuair.
Danish: Nedenstående tabel viser symptomlindring opnået efter 6 måneders behandling med Bretaris Genuair.
English: 1.5 Release the green button (Figure F).
Danish: 1.5 Slip den grønne knap (Figur F).
English: Dry mouth, which has been observed with anticholinergic treatment, may in the long term be associated with dental caries.
Danish: Tør mund, som kan forekomme ved antikolinerg behandling, kan på lang sigt være forbundet med karies.
English: The inhaler is supplied in a plastic laminate pouch, placed in a cardboard carton.
Danish: Inhalatoren leveres i en pose af plastlaminat anbragt i en papkarton.
English: Although no formal in vivo drug interaction studies have been performed, inhaled aclidinium bromide has been used concomitantly with other COPD medicinal products including sympathomimetic bronchodilators, methylxanthines, and oral and inhaled steroids without clinical evidence of drug interactions.
Danish: Selvom ingen formelle in vivo-lægemiddelinteraktionsstudier er blevet udført, er inhaleret aclidiniumbromid blevet anvendt samtidig med andre KOL-lægemidler, herunder sympatomimetiske bronkodilatorer, methylxanthiner og orale og inhalerede steroider uden klinisk tegn på lægemiddelinteraktioner.
English: Consistent with its anticholinergic activity, aclidinium bromide should be used with caution in patients with symptomatic prostatic hyperplasia or bladder-neck obstruction or with narrow-angle glaucoma (even though direct contact of the product with the eyes is very unlikely).
Danish: I overensstemmelse med dets antikolinerge aktivitet skal aclidiniumbromid anvendes med forsigtighed hos patienter med symptomatisk prostatahyperplasi eller blærehalsobstruktion eller med snævervinklet glaukom (omend direkte kontakt af produktet med øjnene er yderst usandsynlig).
English: The following side effects may occur whilst using Bretaris Genuair: Common: may affect up to 1 in 10 people - Headache - Inflammation of the sinuses (sinusitis) - Common cold (nasopharyngitis) - Cough - Diarrhoea - Nausea
Danish: Følgende bivirkninger kan forekomme under brug af Bretaris Genuair: Almindelig: kan påvirke op til 1 ud af 10 mennesker - Hovedpine - Bihulebetændelse (sinusitis) - Forkølelse - Hoste - Diaré - Kvalme
English: You should discard your inhaler if you lose the cap.
Danish: Du bør kassere din inhalator, hvis du mister beskyttelseshætten.
English: Keep the inhaler inside the pouch until the administration period starts.
Danish: Lad inhalatoren forblive i posen, indtil administrationsperioden begynder.
English: It is unknown whether aclidinium bromide / metabolites are excreted in human milk.
Danish: Det er ukendt, om aclidiniumbromid/metabolitter udskilles i human modermælk.
English: Approximately 48% of enrolled patients had a prior history of at least 1 documented previous cardiovascular event; cerebrovascular disease (13.1%), coronary artery disease (35.4%), peripheral vascular disease or history of claudication (13.6%).
Danish: Ca. 48 % af de deltagende patienter havde en anamnese med mindst én dokumenteret kardiovaskulær hændelse; cerebrovaskulær sygdom (13,1 %), koronararteriesygdom (35,4 %) eller perifer vaskulær sygdom, eller havde en anamnese med claudicatio intermittens (13,6 %).
English: 2.6 Slowly breathe out away from the inhaler.
Danish: 2.6 Ånd langsomt ud og væk fra inhalatoren.
English: Go back to ‘STEP 1 Prepare your dose' and repeat steps 1.1 to 1.6.
Danish: Gå tilbage til 'PUNKT 1 Forbered din dosis' og gentag punkt 1.1
English: What to do if the control window is still green after inhalation (Figure L).
Danish: Hvad skal du gøre, hvis kontrolvinduet stadigvæk er grønt efter inhalation (Figur L).
English: Aclidinium bromide is rapidly absorbed from the lung, achieving maximum plasma concentrations within 5 minutes of inhalation in healthy subjects, and normally within the first 15 minutes in COPD patients.
Danish: Aclidiniumbromid absorberes hurtigt fra lungerne, og maksimale plasmakoncentrationer opnås inden for 5 minutter efter inhalation hos raske forsøgspersoner og som regel inden for de første 15 minutter hos patienter med KOL.
English: Aclidinium bromide is rapidly and extensively hydrolysed to its pharmacologically inactive alcoholand carboxylic acid-derivatives.
Danish: Aclidiniumbromid hydrolyseres hurtigt og ekstensivt til dets farmakologisk inaktive alkohol- og kulstofsyrederivater.
English: However, single inhaled doses up to 6,000 µg aclidinium bromide have been administered to healthy subjects without systemic anticholinergic adverse reactions.
Danish: Enkelte inhalerede doser på op til 6.000 µg aclidiniumbromid er dog blevet administreret til raske forsøgspersoner uden systemiske antikolinerge bivirkninger.
English: The active ingredient of Bretaris Genuair is aclidinium bromide, which belongs to a group of medicines called bronchodilators.
Danish: Det aktive indholdsstof i Bretaris Genuair er aclidiniumbromid, som tilhører en række lægemidler betegnet bronkodilatorer.
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the Risk Management Plan presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Danish: Indehaveren af markedsføringstilladelsen skal udføre de lægemiddelovervågningsaktiviteter, som er beskrevet i lægemiddelovervågningsplanen, ifølge RMP'en vist i modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende opdatering af RMP, som er godkendt af Udvalget for Lægemidler til Mennesker (CHMP).
English: Red band
Danish: Rødt bånd
English: Bretaris Genuair may have minor influence on the ability to drive and use machines.
Danish: Bretaris Genuair kan i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Squeeze here and pull
Danish: Tryk her og træk
English: 1.2 Look at the control window (should be red, Figure C).
Danish: 1.2 Se på kontrolvinduet (skal være rødt, Figur C).
English: Bronchodilation
Danish: Bronkodilatation
English: RED
Danish: RØDT
English: Locked
Danish: Låst
English: The low toxicity observed in nonclinical toxicity studies is in part due to rapid metabolism of aclidinium bromide in plasma and the lack of significant pharmacological activity of the major metabolites.
Danish: Den lave toksicitet set i ikke-kliniske forsøg skyldes delvist den hurtige metabolisme af aclidiniumbromid i plasma og manglen på betydelig farmakologisk aktivitet af hovedmetabolitterne.
English: Efficacy was assessed by measures of lung function and symptomatic outcomes such as breathlessness, disease-specific health status, use of rescue medication and occurrence of exacerbations.
Danish: Virkningen blev vurderet ved måling af lungefunktion og symptomatiske resultater såsom kortåndethed, sygdomsspecifik helbredsstatus, brug af anfaldsmedicin og forekomst af exacerbationer.
English: (Figure N), or
Danish: (Figur N), eller
English: 1.3 Hold the inhaler horizontally with the mouthpiece facing you and the green button on top (Figure D).
Danish: 1.3 Hold inhalatoren vandret med mundstykket mod dig og den grønne knap opad (Figur D).
English: Make sure the green button is on top.
Danish: Du skal sikre dig, at den grønne knap er opad.
English: Following inhalation of 200 µg and 400 µg of aclidinium bromide by healthy subjects or COPD patients, the urinary excretion of unchanged aclidinium was very low at about 0.1% of the administered dose, indicating that renal clearance plays a minor role in the total aclidinium clearance from plasma.
Danish: Efter inhalation af 200 µg og 400 µg aclidiniumbromid hos raske forsøgspersoner eller patienter med KOL var udskillelsen af uomdannet aclidinium i urinen meget lav på cirka 0,1 % af den administrerede dosis, hvilket indikerer at clearance i nyrerne spiller en mindre rolle i den samlede clearance af aclidinium fra plasma.
English: No effects on QT interval (corrected using either the Fridericia or Bazett method or individuallycorrected) were observed when aclidinium bromide (200 µg or 800 µg) was administered once daily for 3 days to healthy subjects in a thorough QT study.
Danish: Der blev ikke observeret nogen effekt på QT-intervallet (korrigeret ved Fridericia- eller Bazettmetoden eller individuelt korrigeret), når aclidiniumbromid (200 µg eller 800 µg) blev givet 1 gang dagligt i 3 dage til raske forsøgspersoner i et omhyggeligt QT-studie.
English: 1.4 Press the green button all the way down to load your dose (Figure E).
Danish: 1.4 Tryk den grønne knap helt i bund for at klargøre din dosis (Figur E).
English: Stop taking Bretaris Genuair and seek medical help immediately: - if you get tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine.
Danish: Hold straks op med at tage Bretaris Genuair og søg lægehjælp: - hvis du oplever trykken for brystet, hoste, hvæsende vejrtrækning eller kortåndethed umiddelbart efter brug af lægemidlet.
English: Go to ‘STEP 2: Inhale your medicine'.
Danish: Gå til 'PUNKT 2: Inhalér din medicin'.
English: Effects in nonclinical studies with respect to cardiovascular parameters (increased heart rates in dogs), reproductive toxicity (foetotoxic effects), and fertility (slight decreases in conception rate, number of corpora lutea, and pre- and post-implantation losses) were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Danish: I non-kliniske studier blev der kun iagttaget virkninger på kardiovaskulære parametre (øgede hjertefrekvenser hos hunde), reproduktionstoksicitet (føtotoksiske virkninger) og fertilitet (lille nedgang i drægtighedsprocent, antal af corpus luteum samt abort før og efter implantation) ved doser, der anses for at overstige den maksimale humane eksponering i tilstrækkelig grad.
English: Therefore, please remember to pay attention to oral hygiene.
Danish: Det er derfor vigtigt at være opmærksom på tandhygiejnen.
English: 1.1 Look in the opening of the mouthpiece and make sure nothing is blocking it (Figure C).
Danish: 1.1 Se ind i åbningen på mundstykket for at sikre dig, at det ikke er blokeret (Figur C).
English: The medicine is for inhalation use.
Danish: Anvendelsesmåde Medicinen er til inhalation.
English: White or almost white powder in a white inhaler with an integral dose indicator and a green dosage button.
Danish: Hvidt eller næsten hvidt pulver i en hvid inhalator med en indbygget dosisindikator og en grøn doseringsknap.
English: There is no relevant use of Bretaris Genuair in children and adolescents (under 18 years of age) for the indication of COPD.
Danish: Pædiatrisk population Anvendelse af Bretaris Genuair til børn og unge (under 18 år) til indikationen KOL er ikke relevant.
English: a) Before first use, tear open the sealed bag and remove the inhaler.
Danish: a)Før første anvendelse skal du rive den forseglede pose åben og tage inhalatoren ud.
English: Bretaris Genuair should be used with caution in patients who had a myocardial infarction during the previous 6 months, unstable angina, newly diagnosed arrhythmia within the previous 3 months, or hospitalisation within the previous 12 months for heart failure functional classes III and IV as per the “New York Heart Association”.
Danish: Bretaris Genuair skal anvendes med forsigtighed til patienter, som havde haft hjerteinfarkt i de forudgående 6 måneder, ustabil angina, nyligt diagnosticeret arytmi inden for de forudgående 3 måneder eller hospitalsindlæggelse inden for de forudgående 12 måneder for hjertesvigt (NYHA klasse III og IV).
English: Following intravenous administration of 400 µg radiolabelled aclidinium bromide to healthy subjects, approximately 1% of the dose was excreted as unchanged aclidinium bromide in the urine.
Danish: Efter intravenøs administration af 400 µg radioaktivt mærket aclidiniumbromid til raske forsøgspersoner blev cirka 1 % af dosen udskilt som uændret aclidiniumbromid i urinen.
English: In the 6-month study, patients receiving Bretaris Genuair 322 µg twice daily experienced a clinically meaningful improvement in their lung function (as measured by FEV1).
Danish: I 6-månedersstudiet oplevede patienter, som fik Bretaris Genuair 322 µg to gange dagligt, en klinisk relevant forbedring af deres lungefunktion (målt ved FEV1).
English: The median time on-study in the Bretaris Genuair and placebo groups was approximately 1.4 and 1.3 years, respectively.
Danish: Mediantiden i studiet i Bretaris Genuair-gruppen og placebogruppen var henholdsvis ca. 1,4 og 1,3 år.
English: As aclidinium bromide is metabolised mainly by chemical and enzymatic cleavage in the plasma, hepatic dysfunction is very unlikely to alter its systemic exposure.
Danish: Da aclidiniumbromid hovedsagligt metaboliseres ved kemisk og enzymatisk spaltning i plasma, er det usandsynligt, at nedsat leverfunktion ændrer den systemiske eksponering.