FrancophonIA/ELRC3.0 huggingface dataset:
English: Brimica Genuair is used for maintenance (regular) treatment.
Danish: Brimica Genuair anvendes til regelmæssig behandling (vedligeholdelsesbehandling).
English: The recommended dose of Brimica Genuair is one inhalation twice a day.
Danish: Den anbefalede dosis af Brimica Genuair er én inhalation to gange dagligt.
English: Other information about Brimica Genuair
Danish: Andre oplysninger om Brimica Genuair
English: Regarding safety, the number of side effects reported with Brimica Genuair was low and did not raise any major safety concern.
Danish: Hvad sikkerheden angår, var det indberettede antal bivirkninger med Brimica Genuair lavt og gav ikke anledning til større sikkerhedsmæssige betænkeligheder.
English: A risk management plan has been developed to ensure that Brimica Genuair is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Brimica Genuair anvendes så sikkert som muligt.
English: What is Brimica Genuair and what is it used for?
Danish: Hvad er Brimica Genuair, og hvad anvendes det til?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Brimica Genuair's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Brimica Genuair opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Brimica Genuair is a medicine used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Danish: Brimica Genuair er et lægemiddel, der anvendes til at lindre symptomerne på kronisk obstruktiv lungesygdom (KOL) hos voksne.
English: Side effects with Brimica Genuair are similar to those with the individual components.
Danish: Bivirkningerne med Brimica Genuair svarer til dem, der optræder ved de enkelte bestanddele.
English: The inhaler delivers 340 micrograms of aclidinium and 12 micrograms of formoterol fumarate dihydrate for each inhalation.
Danish: Inhalatoren afgiver 340 µg aclidinium og 12 µg formoterolfumaratdihydrat for hver inhalation.
English: What measures are being taken to ensure the safe and effective use of Brimica Genuair?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Brimica Genuair?
English: Brimica Genuair aclidinium bromide / formoterol fumarate dihydrate
Danish: Brimica Genuair aclidiniumbromid/formoterolfumaratdihydrat
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Brimica Genuair, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Brimica Genuair, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: In addition, as long-acting muscarinic antagonists may have an effect on the heart and blood vessels, the company that markets Brimica Genuair will provide the results of studies to further evaluate the cardiovascular safety of the medicine.
Danish: Da langtidsvirkende muskarinreceptorhæmmere kan påvirke hjerte og blodkar, skal den virksomhed, der markedsfører Brimica Genuair, desuden fremlægge resultater af undersøgelser til yderligere vurdering af lægemidlets hjerte-karsikkerhed.
English: Brimica Genuair is available as an inhalation powder in a portable inhaler device.
Danish: Brimica Genuair fås som et inhalationspulver i en bærbar inhalator.
English: For more information about treatment with Brimica Genuair, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Brimica Genuair, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Why is Brimica Genuair approved?
Danish: Hvorfor blev Brimica Genuair godkendt?
English: However the improvement over formoterol alone was small and not considered clinically significant: FEV1 measured in the morning before the inhalation was 68 ml more with Brimica Genuair than with formoterol alone.
Danish: Forbedringen i forhold til formoterol alene var dog lille og blev ikke anset for at have klinisk betydning: FEV1, målt om morgenen før inhalation, var 68 ml større med Brimica Genuair end med formoterol alene.
English: The most common side effects (seen in around 7 patients in 100) are nasopharyngitis (inflammation of the nose and throat) and headache.
Danish: De hyppigste bivirkninger ved Brimica Genuair (som optræder hos ca. 7 ud af 100 patienter) er næsesvælgbetændelse (nasofaryngitis) og hovedpine.
English: What are the risks associated with Brimica Genuair?
Danish: Hvilke risici er der forbundet med Brimica Genuair?
English: It is not intended to provide practical advice on how to use Brimica Genuair.
Danish: Det er ikke en praktisk vejledning i, hvordan Brimica Genuair bør anvendes.
English: This means that it widens the airways by blocking some receptors in muscle cells in the lungs called muscarinic (also known as cholinergic) receptors, which control the contraction of muscles.
Danish: Det vil sige, at den udvider luftvejene ved at blokere de muskarine receptorer (der også kaldes kolinerge receptorer), som kontrollerer sammentrækningen af muskulaturen i lungerne.
English: Aclidinium bromide has been authorised in the EU as Bretaris Genuair and Eklira Genuair since July 2012; formoterol has been marketed in the EU since the 1990s.
Danish: Aclidiniumbromid har været godkendt i EU under navnene Bretaris Genuair og Eklira Genuair siden juli 2012.
English: Results showed that, after six months of treatment, the increase in FEV1 (measured one hour after an inhalation) was 293 milliliters (ml) more with Brimica Genuair than with placebo and 118 ml more with Brimica Genuair than with aclidinium alone.
Danish: Undersøgelserne viste, at stigningen i FEV1 (målt en time efter inhalation) efter 6 måneders behandling var 293 ml større med Brimica Genuair end med placebo, og 118 ml større med Brimica Genuair end med aclidinium alene.
English: Brimica Genuair has been studied in 2 main studies involving over 3,400 patients with COPD, in which it was compared with aclidinium alone, formoterol alone and placebo (a dummy treatment).
Danish: Brimica Genuair har været genstand for to hovedundersøgelser med over 3 400 patienter med KOL, hvor det blev sammenlignet med aclidinium alene, formoterol alene og virkningsløs behandling (placebo).
English: Brimica Genuair was also shown to increase the percentage of patients who had an improvement in breathlessness compared with placebo.
Danish: Brimica Genuair øgede desuden den andel af patienterne, der fik bedring i stakåndethed i forhold til placebo.
English: For the full list of all side effects and restrictions with Brimica Genuair, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Brimica Genuair fremgår af indlægssedlen.
English: The main measure of effectiveness was based on changes in patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second) after six months.
Danish: Virkningen blev hovedsagelig bedømt på, hvor stor bedring der efter seks måneder var i den maksimale luftmængde, patienten kan udånde på et sekund (det forcerede ekspirationsvolumen, FEV1).
English: The CHMP noted that Brimica Genuair was shown to significantly improve lung function in patients with COPD compared with placebo, although the improvement observed when Brimica Genuair was compared with one of the components on its own, formoterol, was small.
Danish: CHMP bemærkede, at Brimica Genuair var påvist at forbedre lungefunktionen væsentligt hos patienter med KOL i forhold til placebo, men at forbedringen med Brimica Genuair var lille i forhold til særskilt brug af den ene af komponenterne, nemlig formoterol.
English: For practical information about using Brimica Genuair, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Brimica Genuair, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Brimica Genuair contains two active substances: aclidinium bromide and formoterol fumarate dihydrate.
Danish: Brimica Genuair indeholder de to aktive stoffer aclidiniumbromid og formoterolfumaratdihydrat.
English: It works by attaching to receptors known as beta-2 receptors found in the muscles of the airways.
Danish: Det virker ved at bindes til beta-2receptorerne i luftvejenes muskulatur.
English: The two active substances in Brimica Genuair, aclinidium bromide and formoterol fumarate dihydrate, work by keeping the airways open and allowing the patient to breathe more easily.
Danish: De to aktive stoffer i Brimica Genuair, aclidiniumbromid og formoterolfumaratdihydrat, virker ved at holde luftvejene frie, så vejrtrækningen lettes.
English: Brimica Genuair can only be obtained with a prescription.
Danish: Lægemidlet udleveres kun efter recept.
English: When it attaches to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.
Danish: Når det bindes til disse receptorer, afslapper det musklerne, så luftvejene holdes frie, og patienten bedre kan trække vejret.
English: When aclidinium bromide is inhaled, it causes the muscles of the airways to relax, helping to keep the airways open and allowing the patient to breathe more easily.
Danish: Når aclidiniumbromid inhaleres, får det muskulaturen i luftvejene til at afslappes, så luftvejene bedre holdes frie, og patienten bedre kan trække vejret.
English: Aclidinium bromide is a long-acting muscarinic antagonist.
Danish: Aclidiniumbromid er en langtidsvirkende muskarinreceptorhæmmer.
English: How does Brimica Genuair work?
Danish: Hvordan virker Brimica Genuair?
English: How is Brimica Genuair used?
Danish: Hvordan anvendes Brimica Genuair?
English: What benefits of Brimica Genuair have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Brimica Genuair?
English: For detailed information on how to use the inhaler correctly, see the instructions in the package leaflet.
Danish: I indlægssedlen er der detaljerede anvisninger for, hvordan inhalatoren skal bruges.
English: Long-acting muscarinic antagonists and long-acting beta-2 agonists are commonly combined in the management of COPD.
Danish: Det er almindeligt at behandle KOL med en kombination af muskarinreceptorhæmmere og langtidsvirkende beta-2-stimulerende midler.
English: Some of these cases have been fatal.
Danish: Nogle af disse tilfælde var dødelige.
English: It should be noted that the literature studies may have limitations.
Danish: Det bør bemærkes, at litteraturstudierne kan have begrænsninger.
English: There is no information available concerning the first trimester.
Danish: Der foreligger ingen information om første trimester.
English: ATC code: B01A B05
Danish: ATC-kode: B01A B05
English: Different doses and formulations and dosing regimens can be used.
Danish: Der kan anvendes forskellige doser og formuleringer og doseringsregimer.
English: Thorinane works in two ways.
Danish: Thorinane virker på to måder.
English: The usual duration of treatment is 2 to 8 days.
Danish: Den sædvanlige behandlingsvarighed er 2-8 dage.
English: Steady-state is achieved on the second day of treatment.
Danish: Steady state opnås på behandlingens 2. dag.
English: Your doctor should discuss this with you.
Danish: Lægen vil drøfte dette med dig.
English: Date of first authorisation: 15/09/2016
Danish: Dato for første markedsføringstilladelse: 15/09/2016
English: The patients were followed for three months.
Danish: Patienterne blev fulgt i tre måneder.
English: You should tell your doctor straight away
Danish: Du skal straks fortælle det til lægen
English: Prophylaxis should be continued until the patient no longer has significantly reduced mobility.
Danish: Profylakse bør fortsættes, indtil patienten ikke længere har signifikant reduceret mobilitet.
English: 2) Sit or lie in a comfortable position so you are relaxed.
Danish: 2) Sæt eller læg dig i en behagelig stilling, så du er afslappet.
English: Treatment of DVT and PE
Danish: Behandling af DVT og PE
English: Confounding factors, including underlying disease and insufficient clinical data, limit the evaluation of these cases.
Danish: Konfunderende faktorer, inklusive underliggende sygdomme og utilstrækkelige kliniske data, begrænser evalueringen af disse tilfælde.
English: Circulating antibodies may persist several years.
Danish: Cirkulerende antistoffer kan være til stede i flere år.
English: It should not be mixed or co-administered with other medications.
Danish: Det bør ikke blandes eller administreres sammen med andre lægemidler.
English: Treatment continued for 6 to 14 days (median duration 7 days).
Danish: Behandlingen varede i 6 til 14 dage (median varighed 7 dage).
English: A total of 1,102 patients were enrolled in the study, and 1,073 patients were treated.
Danish: I alt 1.102 patienter deltog i studiet, og 1.073 patienter blev behandlet.
English: They resolve after a few days and should not cause treatment discontinuation.
Danish: De forsvinder efter et par dage og bør ikke forårsage behandlingsafbrydelse
English: A total of 900 patients were randomized in the study and all patients were treated.
Danish: I alt 900 patienter blev randomiseret i studiet, og alle patienter blev behandlet.
English: • Skin irritation (local irritation).
Danish: • Hudirritation (lokal irritation).
English: The benefit is not established for a treatment longer than 14 days.
Danish: Der er ikke påvist behandlingsfordel ved behandling ud over 14 dage.
English: Do not use this medicine after the expiry date which is stated on the label and carton.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og kartonen.
English: Your doctor will be able to check this by carrying out a blood test.
Danish: Lægen kan kontrollere dette ved at tage en blodprøve.
English: CHINA
Danish: KINA
English: All patients were also treated with acetylsalicylic acid for a minimum of 30 days.
Danish: Alle patienter fik også acetylsalicylsyre i mindst 30 dage.
English: The amount of Thorinane given to you will depend on your age and the kind of heart attack you have had.
Danish: Den dosis Thorinane, du får, afhænger af din alder og den type hjerteanfald, du har haft.
English: It is recommended to prepare the dilution immediately before use.
Danish: Det anbefales at tilberede opløsningen umiddelbart før anvendelse.
English: • you have had an operation recently on your eyes or brain • you are elderly (over 65 years old) and especially if you are over 75 years old
Danish: • hvis du for nyligt er blevet opereret i øjnene eller hjernen • hvis du er ældre (over 65 år) og især, hvis du er over 75 år
English: Like all medicines, this medicine can cause side-effects although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: This is because they are not exactly the same and do not have the same activity and instructions for use.
Danish: Det skyldes, at de ikke er helt ens, ikke virker på samme måde og ikke skal anvendes på samme måde.
English: 3) Choose an area on the right or left side of your stomach.
Danish: 3) Vælg et område på højre eller venstre side af din mave.
English: Do not put it in the household rubbish.
Danish: Du må ikke smide den i skraldespanden.
English: • You bruise more easily than usual.
Danish: • Du får blå mærker lettere end normalt.
English: • Severe allergic reaction.
Danish: • Alvorlig allergisk reaktion.
English: Following repeated SC administration no accumulation takes place.
Danish: Efter gentagen subkutan administration finder der ikke nogen akkumulation sted.
English: If not, use another syringe.
Danish: Hvis det ikke er tilfældet, skal du bruge en anden sprøjte.
English: Do not try to inject yourself if you have not been trained how to do so.
Danish: Du må ikke give dig selv en indsprøjtning, hvis du ikke har lært, hvordan man skal gøre.
English: There were no differences in the rates of bleeding or other complications during the double-blind or follow-up periods.
Danish: Der var ingen forskel i hyppigheden af blødning eller andre komplikationer i den dobbeltblinde periode eller i opfølgningsperioden.
English: The beneficial effect of enoxaparin sodium on the primary end point observed during the first 30 days was maintained over a 12 month follow-up period.
Danish: Den gavnlige virkning af enoxaparinnatrium på det primære effektmål, der blev observeret i løbet af de første 30 dage, blev opretholdt over en opfølgningsperiode på 12 måneder.
English: • If you are going to have an operation your first injection will be usually given 2 hours or 12 hours before your operation.
Danish: • Hvis du skal opereres, vil du normalt få den første indsprøjtning 2 timer eller 12 timer inden operationen.
English: Enoxaparin sodium should be used during pregnancy only if the physician has established a clear need.
Danish: Enoxaparinnatrium bør kun anvendes under graviditet, hvis lægen har fastlagt et klart behov.
English: • A feeling of tenderness and swelling in your stomach.
Danish: • En følelse af ømhed og hævelse i maven.
English: Intra-patient and inter-patient variability is low.
Danish: Den intra- og inter-individuelle variabilitet er lav.
English: It is important to achieve haemostasis at the puncture site after PCI.
Danish: Det er vigtigt at opnå hæmostase ved punkturstedet efter PCI.
English: • Common: Allergic reaction
Danish: • Almindelig: Allergisk reaktion
English: This is more likely to happen in people with kidney problems or diabetes.
Danish: Dette er mere sandsynligt hos personer med nyreproblemer eller sukkersyge (diabetes).
English: Athens, Attiki 15771
Danish: Athen, Attiki 15771
English: The patients had to be followed up to 30 days.
Danish: Patienterne blev fulgt i op til 30 dage.
English: Throw away the cap.
Danish: Smid hætten væk.
English: When used as curative treatment, aPTT can be prolonged by 1.5-2.2 times the control time at peak activity.
Danish: Når det anvendes som kurativ behandling, kan aPTT være forlænget med 1,5-2,2 gange kontroltiden ved maksimal aktivitet.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Samtidig anvendelse frarådes
English: • Common: Urticaria, pruritus, erythema
Danish: • Almindelig: Urticaria, pruritus, erytem
English: Your doctor may decide to keep you under closer observation or change your medicine.
Danish: Lægen vil muligvis følge dig tæt eller ændre din behandling.
English: Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations on the syringe, and in such case the volume shall be rounded up to the nearest graduation.
Danish: Vær opmærksom på, at det i nogen tilfælde ikke er muligt at opnå en præcis dosis på grund af gradueringen på injektionssprøjten, og i sådanne tilfælde bør volumen rundes op til den nærmeste delestreg.
English: Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); and very rare (< 1/10,000) or not known (cannot be estimated from available data).
Danish: Hyppigheden er defineret på følgende måde: 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: Before injecting yourself with Thorinane - Check the expiry date on the medicine.
Danish: Inden du giver dig selv en indsprøjtning med Thorinane - Undersøg udløbsdatoen på lægemidlet.
English: VTE = venous thromboembolic event (DVT and/or PE) *The 95% Confidence Intervals for the treatment differences for total VTE were:
Danish: VTE = venetromboembolisk hændelse (DVT og/eller PE) *95 % konfidensintervaller for behandlingsforskelle for totalt antal VTE var:
English: - Make sure you know how much you are going to inject.
Danish: - Sørg for, at du ved, hvor meget du skal indsprøjte.
English: After dilution the solution should be used within 8 hours.
Danish: Efter fortynding skal opløsningen anvendes inden for 8 timer.
English: Special attention and compliance with the instructions for use specific to each proprietary medicinal product are therefore required.
Danish: Særlig opmærksomhed og overholdelse af brugervejledningen for de enkelte registrerede lægemidler er derfor nødvendig.
English: • Lost of control over your bladder or bowel (so you cannot control when you go to the toilet).
Danish: • Manglende kontrol over blære eller tarme (så man ikke kan kontrollere, hvornår man skal på toilettet).
English: Plasma potassium should be monitored regularly especially in patients at risk.
Danish: Plasmakalium skal monitoreres regelmæssigt, særligt hos patienter i risikogruppe.
English: How much will be given to you
Danish: Så meget får du
English: Thorinane is a biosimilar medicinal product.
Danish: Thorinane er et biosimilært lægemiddel.
English: The drug substance is the sodium salt.
Danish: Det aktive lægemiddel er natriumsaltet.
English: Retroperitoneal and intracranial haemorrhages were always considered major.
Danish: Retroperitoneale og intrakranielle blødninger blev altid anset som alvorlige.
English: Elderly patients (especially patients eighty years of age and older) may be at an increased risk for bleeding complications with the therapeutic dosage ranges.
Danish: Ældre patienter (især patienter ≥ 80 år) kan have en øget risiko for blødningskomplikationer ved doser i de terapeutiske dosisintervaller.
English: In case a closure device is used, the sheath can be removed immediately.
Danish: Hvis der anvendes en lukkeanordning, kan sheathen fjernes med det samme.
English: This reduction in the combined incidence was maintained after 30 days (from 23.3 to 19.8%; relative risk reduction of 15%).
Danish: Faldet i den samlede incidens var opretholdt efter 30 dage (fra 23,3 til 19,8 %; relativ risikoreduktion på 15 %).
English: - Decide where you are going to inject the medicine.
Danish: - Beslut dig for hvilket sted, du vil indsprøjte lægemidlet.
English: Treatment in patients with DVT with or without PE
Danish: Behandling af patienter med DVT med eller uden PE
English: Enoxaparin sodium is contraindicated in patients with:
Danish: Enoxaparinnatrium er kontraindiceret hos patienter med:
English: • Sudden severe headache.
Danish: • Pludselig, kraftig hovedpine.
English: Some of these cases were pregnant women in whom thrombosis led to maternal and foetal death.
Danish: Nogle af disse tilfælde optrådte hos gravide kvinder, hvor trombose medførte maternel og føtal død.
English: Thorinane is indicated in adults for:
Danish: Thorinane er indiceret til voksne til:
English: As with other anticoagulants, bleeding may occur at any site.
Danish: Som med andre antikoagulantia kan der forekomme blødning alle steder.
English: If bleeding occurs, the origin of the haemorrhage should be investigated and appropriate treatment instituted.
Danish: Hvis der opstår blødning, bør blødningens oprindelse undersøges og passende behandling initieres.
English: The recommended dosage adjustments do not apply to the haemodialysis indication.
Danish: De anbefalede dosisjusteringer gælder ikke i forbindelse med indikationen hæmodialyse.
English: o For dosage in patients ≥ 75 years of age, see paragraph “Elderly”.
Danish: o Dosering til patienter ≥ 75 år, se afsnittet ”Ældre”.
English: These reactions have resulted in varying degrees of neurologic injuries including long-term or permanent paralysis (see section 4.4).
Danish: Disse reaktioner har resulteret i varierende grader af neurologiske skader, inklusive langvarig eller permanent parese (se pkt.