FrancophonIA/ELRC3.0 huggingface dataset:
English: The most frequently reported adverse reactions with Brimica Genuair were nasopharyngitis (7.9%) and headache (6.8%).
Danish: De hyppigst indberettede bivirkninger med Brimica Genuair var forkølelsessymptomer (nasopharyngitis) (7,9 %) og hovedpine (6,8 %).
English: Cytochrome P450 isoenzymes CYP2D6, CYP2C19, CYP2C9 and CYP2A6 are involved in the O-demethylation of formoterol.
Danish: Cytokrom P450 isoenzymerne CYP2D6, CYP2C19, CYP2C9 og CYP2A6 indgår i O-demethyleringen af formoterol.
English: Medicinal products that are known to prolong the QTc interval are associated with an increased risk of ventricular arrhythmias.
Danish: Lægemidler, der vides at forlænge QTc-intervallet, er forbundet med øget risiko for ventrikulære arytmier.
English: If your usual COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse while you are using Brimica Genuair you should continue to use it, but go to see your doctor as soon as possible because you may need another medicine.
Danish: Hvis dine sædvanlige KOL-symptomer (kortåndethed, hvæsen, hoste) ikke forbedres eller bliver værre, mens du bruger Brimica Genuair, skal du fortsætte med at bruge det, men kontakte din læge så hurtigt som muligt, fordi du kan have brug for et andet lægemiddel.
English: The low absolute bioavailability of inhaled aclidinium (<5%) is because aclidinium undergoes extensive systemic and pre-systemic hydrolysis whether deposited in the lung or swallowed.
Danish: Den lave absolutte biotilgængelighed af inhaleret aclidinium (<5 %) skyldes, at aclidinium gennemgår omfattende systemisk og præsystemisk hydrolysering, uanset om det deponeres i lungerne eller sluges.
English: The Genuair inhaler delivers the active ingredients directly into your lungs as you breathe in.
Danish: Genuair-inhalatoren leverer de aktive stoffer direkte ind i dine lunger, når du ånder ind.
English: There is no relevant use of Brimica Genuair in children and adolescents (under 18 years of age) for the indication of COPD.
Danish: Der er ingen relevant anvendelse af Brimica Genuair til børn og unge (under 18 år) til indikationen KOL.
English: Tell your doctor or pharmacist if you are taking:
Danish: Fortæl din læge eller apotekspersonalet, hvis du tager:
English: Dry mouth, which has been observed with anticholinergic treatment, may in the long term be associated with dental caries.
Danish: Tør mund, som er blevet observeret med antikolinerg behandling, kan på længere sigt være forbundet med karies.
English: Children and adolescents Brimica Genuair is not for use in children or adolescents below 18 years of age.
Danish: Børn og unge Brimica Genuair er ikke beregnet til brug hos børn eller unge under 18 år.
English: Taking Brimica Genuair regularly will reduce the effects of COPD on your everyday life.
Danish: Ved at tage Brimica Genuair regelmæssigt nedsættes KOL´s påvirkning af din dagligdag.
English: Do not use Brimica Genuair: - if you are allergic to aclidinium, formoterol fumarate dihydrate or to the other ingredient of this medicine (listed in Section 6).
Danish: Brug ikke Brimica Genuair: - hvis du er allergisk over for aclidinium, formoterolfumaratdihydrat eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: - If you have an eye condition called narrow angle glaucoma, which results in high pressure in the eye.
Danish: - Hvis du har en øjensygdom, der hedder snævervinklet glaukom, som resulterer i højt tryk i øjet.
English: Even though the orange button is locked, your last dose may still be inhaled.
Danish: Selvom den orange knap er låst, kan du stadigvæk inhalere den sidste dosis.
English: Maximal bronchodilator effects (peak FEV1) relative to baseline were evident from day one (304 ml) and were maintained over the 6-month treatment period (326 ml).
Danish: Maksimale bronkodilaterende virkninger (peak FEV1) i forhold til baseline var tydelige fra første dag (304 ml) og blev opretholdt over den 6-måneders behandlingsperiode (326 ml).
English: Aclidinium/formoterol did not statistically significantly reduce the average number of night-time awakenings due to COPD compared with placebo or formoterol.
Danish: Aclidinium/formoterol reducerede ikke statistisk signifikant det gennemsnitlige antal opvågninger i løbet af natten på grund af KOL sammenlignet med placebo eller formoterol.
English: Electrocardiogram QTc prolonged Palpitations
Danish: Elektrokardiogram QTc-forlængelse Palpitationer
English: In addition to improving pulmonary function, formoterol has been shown to improve symptoms and quality of life in patients with COPD.
Danish: Ud over at forbedre lungefunktionen er det påvist, at formoterol forbedrer symptomer og livskvalitet hos patienter med KOL.
English: Do not hold the orange button down while inhaling.
Danish: Hold ikke den orange knap nede mens du inhalerer.
English: In long-term safety studies, Brimica Genuair was associated with sustained efficacy when administered over a one-year treatment period with no evidence of tachyphylaxis.
Danish: I langsigtede sikkerhedsstudier var Brimica Genuair forbundet med vedvarende effekt, når det blev administreret over en et-årig behandlingsperiode uden tegn på takyfylaksi.
English: Biotransformation via CYP450 enzymes plays a minor role in the total metabolic clearance of aclidinium.
Danish: Biotransformation via CYP450-enzymer spiller en mindre rolle i den samlede metaboliske clearance af aclidinium.
English: Aclidinium is rapidly and extensively hydrolysed to its pharmacologically inactive alcohol- and carboxylic acid-derivatives.
Danish: Aclidinium hydrolyseres hurtigt og ekstensivt til dets farmakologiske inaktive alkohol- og karboxylsyrederivater.
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: Plasmaniveauerne for syremetabolitten er cirka 100 gange større end for alkoholmetabolitten og det uomdannede aktive stof efter inhalation.
English: Менарини България” EООД тел.
Danish: Менарини България” EООД
English: Formoterol is a potent selective β2-adrenoceptor agonist.
Danish: Formoterol er en potent selektiv β2-adrenoceptor agonist.
English: Paradoxical bronchospasm
Danish: Paradoksal bronkospasme
English: After you have taken the last dose, the inhaler has to be disposed of.
Danish: Efter du har taget den sidste dosis, skal inhalatoren bortskaffes.
English: The safety experience with Brimica Genuair comprised exposure in clinical trials at the recommended therapeutic dose for up to 12 months, and in post-marketing experience.
Danish: De sikkerhedsmæssige erfaringer med Brimica Genuair omfatter eksponering i kliniske studier ved den anbefalede terapeutiske dosis i op til 12 måneder samt ved erfaring efter markedsføring.
English: As studies in rats have shown excretion of small amounts of aclidinium (and/or its metabolites) and formoterol into milk, the use of Brimica Genuair by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant.
Danish: Da studier på rotter har påvist udskillelse af små mængder aclidinium (og/eller metabolitter) og formoterol i modermælk, bør ammende kvinders anvendelse af Brimica Genuair kun overvejes, hvis den forventede fordel for kvinden er større end en eventuel risiko for barnet.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, adrenergics in combination with anticholinergics, ATC code: R03AL05
Danish: Farmakoterapeutisk klassifikation: Midler mod obstruktiv lungesygdom, adrenergica i kombination med anticholinergica, ATC-kode: R03AL05
English: After inhalation, 6% to 9% of the delivered dose of formoterol is excreted in the urine unchanged or as direct conjugates of formoterol.
Danish: Efter inhalation udskilles 6 % til 9 % af den leverede dosis formoterol uændret i urinen eller som direkte konjugater af formoterol.
English: If you forget a dose of Brimica Genuair, just take it as soon as possible and take your next dose at the usual time.
Danish: Hvis du glemmer en dosis Brimica Genuair, skal du bare tage den så snart som muligt og tage din næste dosis på det sædvanlige tidspunkt.
English: Talk to your doctor, pharmacist or nurse before using Brimica Genuair, if you have any of the following conditions/symptoms: - If you have asthma.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Brimica Genuair, hvis du har nogen af følgende lidelser/symptomer: - Hvis du har astma.
English: - Brimica Genuair is for inhalation use.
Danish: - Brimica Genuair er til inhalation.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for aclidinium bromide / formoterol fumarate dihydrate, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR´en/PSUR'erne for aclidiniumbromid/formoterolfumaratdihydrat er CHMP nået frem til følgende videnskabelige konklusioner:
English: When aclidinium and formoterol were administered in combination by the inhaled route, the pharmacokinetics of each component showed no relevant differences from those observed when the medicinal products were administered separately.
Danish: Når aclidinium og formoterol blev administreret sammen via inhalation, var farmakokinetikken for hver komponent ikke væsentlig forskellig fra det, der blev observeret, når lægemidlerne blev administreret hver for sig.
English: EU/1/14/963/001 1 inhaler with 60 doses EU/1/14/963/002 3 inhalers each with 60 doses EU/1/14/963/003 1 inhaler with 30 doses
Danish: EU/1/14/963/001 1 inhalator med 60 doser EU/1/14/963/002 3 inhalatorer hver med 60 doser EU/1/14/963/003 1 inhalator med 30 doser
English: 1.5 Release the orange button (Figure F).
Danish: 1.5 Slip den orange knap (Figur F).
English: Dose indicator
Danish: Dosis indikator
English: There was a sustained effect over time in the six-months and one-year Phase III studies.
Danish: Der var en vedvarende effekt over tid i de fase III-studier, som varede i henholdsvis 6 måneder og 1 år.
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/formoterol, according to a protocol agreed by the PRAC.
Danish: Fremsendelse af resultaterne af den aftalte sikkerhedsundersøgelse efter markedsføringstilladelse (post-authorisation safety study, PASS) for aclidiniumbromid, som er aftalt til evaluering af den totale mortalitet og de foreslåede kardiovaskulære sikkerheds-endpoints (med yderligere et endpoint for kardiel arytmi) blandt patienter med KOL, der bruger aclidinium/formoterol, i henhold til en protokol accepteret af PRAC.
English: Keep the Genuair inhaler protected inside the sealed bag until the administration period starts.
Danish: Lad Genuair-inhalatoren forblive beskyttet i den forseglede pose indtil administrationsperioden begynder.
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: Patienterne skal instrueres i, hvordan præparatet administreres korrekt, da Genuair inhalator kan fungere forskelligt fra inhalatorer, som patienten måske har anvendt tidligere.
English: The Brimica Genuair clinical development programme was conducted in patients with moderate or severe COPD.
Danish: Det kliniske udviklingsprogram for Brimica Genuair blev udført hos patienter med moderat eller svær KOL.
English: As Brimica Genuair contains aclidinium and formoterol, the type and severity of adverse reactions associated with each of the components may be expected with Brimica Genuair.
Danish: Da Brimica Genuair indeholder aclidinium og formoterol, kan det forventes, at typen og sværhedsgraden af bivirkninger forbundet med hver af komponenterne også vil forekomme med Brimica Genuair.
English: However, paradoxical bronchospasm has been observed with other inhalation therapies.
Danish: Der er imidlertid observeret paradoksal bronkospasme i forbindelse med andre inhalationsbehandlinger.
English: Based on the above mentioned data, the PRAC considered that ‘peripheral oedema' should be removed from the list of adverse drug reactions in section 4.8 of the SmPC and ‘Swelling of hands, ankles or feet' should be deleted in section 4 of the Package Leaflet.
Danish: På baggrund af ovennævnte data fandt PRAC, at "perifert ødem" skal fjernes fra listen over bivirkninger i punkt 4.8 i produktresuméet, og "hævelse i hænder, ankler eller fødder" skal slettes i punkt 4 i indlægssedlen.
English: In clinical studies, paradoxical bronchospasm was not observed with Brimica Genuair at its recommended dose.
Danish: I kliniske studier blev der ikke observeret paradoksal bronkospasme med Brimica Genuair ved den anbefalede dosis.
English: Formoterol showed reduced fertility (implantation losses) in rats, as well as decreased early postnatal survival and birth weight with high systemic exposure to formoterol.
Danish: Formoterol udviste nedsat fertilitet (implantationstab) hos rotter, såvel som nedsat for tidlig postnatal overlevelse og fødselsvægt med høj systemisk eksponering for formoterol.
English: What to do if the control window is still red after pressing the button (Figure H).
Danish: Hvad skal du gøre, hvis kontrolvinduet stadigvæk er rødt efter at have trykket på knappen (Figur H).
English: Bronchodilation is induced by causing direct relaxation of airway smooth muscle as a consequence of the increase in cyclic AMP through activation of adenylate cyclase.
Danish: Bronkodilatation induceres ved at forårsage direkte afslapning af luftvejenes glatte muskulatur som følge af stigningen i cyklisk AMP gennem aktivering af adenylatcyclase.
English: Make sure you have released the orange button, and you have breathed out completely.
Danish: Du skal sikre dig, at du har sluppet den orange knap, og at du har åndet helt ud.
English: No clinically significant effects of Brimica Genuair on cardiac rhythm were observed on 24-hour Holter monitoring in a subset of 551 patients, of whom 114 received Brimica Genuair twice daily.
Danish: Der sås ingen klinisk signifikant effekt af Brimica Genuair på hjerterytmen under 24-timers Holter-monitorering i et udsnit på 551 patienter, hvoraf 114 fik Brimica Genuair to gange dagligt.
English: Dry mouth has been observed with medicines like Brimica Genuair.
Danish: Der er observeret tør mund med lægemidler som Brimica Genuair.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before using this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du bruger dette lægemiddel.
English: As a consequence of the differential density of muscarinic receptors and β2-adrenoceptors in the central and peripheral airways of the lung, muscarinic antagonists should be more effective in relaxing central airways and β2-adrenergic agonists should be more effective in relaxing peripheral airways; relaxation of both central and peripheral airways with combination treatment may contribute to its beneficial effects on lung function.
Danish: Som følge af den differentierede tæthed af muskarinreceptorer og β2-adrenoceptorer i lungernes centrale og perifere luftveje skal muscarinantagonister være mere effektive til at afslappe centrale luftveje, og β2-adrenerge agonister skal være mere effektive til at afslappe perifere luftveje; afslapningen af både centrale og perifere luftveje med kombinationsbehandling kan bidrage til en positiv indvirkning på lungefunktionen.
English: Other pharmacodynamic interactions
Danish: Andre farmakodynamiske interaktioner
English: The Genuair inhaler is a multicomponent device made of plastic (polycarbonate, acrylonitrilebutadiene-styrene, polyoxymethylene, polyester-butylene-terephthalate, polypropylene, polystyrene) and stainless steel.
Danish: Genuair-inhalatoren er en anordning med flere komponenter, der er fremstillet af plastik (polycarbonat, acrylonitril-butadien-styren, polyoxymethylen, polyesterbutylenterephthalat, polypropylen, polystyren) og rustfrit stål.
English: These may be signs of a condition called “paradoxical bronchospasm”, which is an excessive and prolonged contraction of the airway muscles immediately following treatment with a bronchodilator.
Danish: Dette kan være tegn på en tilstand betegnet ”paradoksal bronkospasme”, som er en for kraftig og langvarig sammentrækning af luftvejsmusklerne umiddelbart efter behandling med et lægemiddel, der udvider bronkierne.
English: During these studies, patients were permitted to continue their stable treatment with inhaled corticosteroids, low doses of oral corticosteroids, oxygen therapy (if less than 15h/day) or methylxanthines and to use salbutamol as rescue medication.
Danish: Under disse studier fik patienterne lov til at fortsætte deres stabile behandling med inhalerede kortikosteroider, lave doser af orale kortikosteroider, iltbehandling (hvis mindre end 15 timer/dag) eller methylxantiner og at bruge salbutamol som anfaldsmedicin.
English: Brimica Genuair contains two bronchodilators: aclidinium is a long-acting muscarinic antagonist (also known as an anticholinergic) and formoterol is a long-acting β2-adrenergic agonist.
Danish: Brimica Genuair indeholder to bronkodilatatorer: Aclidinium er en langtidsvirkende muskarin antagonist (også kendt som en antikolinerg) og formoterol er en langtidsvirkende β2-adrenerg agonist.
English: Taking your medicine at regular times will also help you to remember to use it. - The recommended dose can be used for elderly patients and for patients with kidney or liver problems.
Danish: Det vil også hjælpe dig med at huske at bruge den. - Den anbefalede dosis kan anvendes til ældre patienter og til patienter med nedsat nyre- eller leverfunktion.
English: - Instructions for use: Refer to the Instructions for Use at the end of this leaflet for instructions on how to use the Genuair inhaler.
Danish: - Brugsanvisning: Se Brugsanvisningen i slutningen af denne indlægsseddel for vejledning i brug af Genuair-inhalatoren.
English: β-adrenergic blockers β-adrenergic blockers may weaken or antagonise the effect of β2-adrenergic agonists.
Danish: β-adrenerge blokkere β-adrenerge blokkere kan svække eller modvirke virkningen af β2-adrenerge agonister.
English: Bronchodilators relax the muscles in your airways, which allows the airways to open more widely and helps you to breathe more easily.
Danish: Bronkodilatatorer virker afslappende på musklerne i dine luftveje, hvilket gør luftvejene i stand til at udvide sig mere og gør det lettere for dig at trække vejret.
English: These include medicines for the treatment of: o depression (such as monoamine oxidase inhibitors or tricyclic antidepressants), o bacterial infections (such as erythromycin, clarithromycin, telithromycin), o allergic reactions (anti-histamines).
Danish: Disse inkluderer medicin til behandling af: o depression (såsom monoaminooxidasehæmmere eller tricykliske antidepressiva), o bakterieinfektioner (såsom erythromycin, clarithromycin, telithromycin), o allergiske reaktioner (antihistaminer).
English: Due to its anticholinergic activity, Brimica Genuair should be used with caution in patients with symptomatic prostatic hyperplasia, urinary retention or narrow-angle glaucoma (even though direct contact of the product with the eyes is very unlikely).
Danish: På grund af sin antikolinerge aktivitet bør Brimica Genuair anvendes med forsigtighed hos patienter med symptomatisk prostatahyperplasi, urinretention eller snævervinklet glaukom (selvom det er meget usandsynligt, at produktet får direkte kontakt med øjnene).
English: Brimica Genuair is used as a maintenance (long-term) treatment for COPD.
Danish: Brimica Genuair anvendes som (langsigtet) vedligeholdelsesbehandling af KOL.
English: If you see halos around lights or coloured images, have eye pain or discomfort or suffer temporary blurring of vision, go to see your doctor for advice as soon as possible.
Danish: Hvis du ser ringe omkring lys eller farvede billeder, har smerter i øjnene eller ubehag eller har midlertidig sløring af synet, skal du søge læge for at få råd så hurtigt som muligt.
English: On the basis of the scientific conclusions for aclidinium bromide / formoterol fumarate dihydrate the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing aclidinium bromide / formoterol fumarate dihydrate is unchanged subject to the proposed changes to the product information
Danish: På baggrund af de videnskabelige konklusioner for aclidiniumbromid/formoterolfumaratdihydrat er CHMP af den opfattelse, at benefit/risk-forholdet for de lægemidler, der indeholder aclidiniumbromid/formoterolfumaratdihydrat, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: β2-adrenergic agonists may produce increases in pulse rate and blood pressure, electrocardiogram (ECG) changes such as T wave flattening, ST segment depression and prolongation of the QTcinterval in some patients.
Danish: β2-adrenerge agonister kan medføre stigninger i puls og blodtryk, ændringer i elektrokardiogram (EKG), såsom udfladning af T-tak, ST-segmentdepression og forlængelse af QTc-intervallet hos nogle patienter.
English: A slight increase in the incidence of uterine leiomyomas has been observed in rats and mice; an effect which is considered to be a classeffect in rodents after long-term exposure to high doses of β2-adrenoreceptor agonists.
Danish: En lille stigning i forekomsten af uterine leiomyomer er blevet observeret i rotter og mus; en effekt, der anses for at være en klasse-effekt i gnavere efter langvarig udsættelse for høje doser β2-adrenoreceptoragonister.
English: During the reporting period of the PSUR, study D6560C00002 was completed and showed that the proportion of patients with an adverse event of ‘peripheral oedema' was numerically lower in the aclidinium group than in the placebo group.
Danish: I rapporteringsperioden for PSUR'en blev studiet D6560C00002 afsluttet, og det viste, at andelen af patienter med bivirkningen "perifert ødem" var numerisk lavere i aclidiniumgruppen end i placebogruppen.
English: A total of 1222 patients were treated with Brimica Genuair 340 micrograms /12 micrograms.
Danish: I alt 1222 patienter blev behandlet med Brimica Genuair 340 mikrogram/12 mikrogram.
English: Nonclinical data reveal no special hazard for humans with aclidinium and formoterol based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential and toxicity to reproduction and development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker ved aclidinium og formoterol vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: In Phase III clinical studies, the frequency of notable increases in blood glucose with Brimica Genuair was low (0.1%) and similar to placebo.
Danish: I kliniske fase III-studier var hyppigheden af markante stigninger i blodsukker i forbindelse med Brimica Genuair lav (0,1 %) og svarede til placebo.
English: - Getting started - Step 1: Prepare your dose - Step 2: Inhale your medicine - Additional information
Danish: Brugsanvisningen er inddelt i følgende afsnit: - Før opstart - Punkt 1: Forbered din dosis - Punkt 2: Inhalér din medicin - Yderligere information
English: Angioedema Anaphylactic reaction
Danish: Angioødem Anafylaktisk reaktion