FrancophonIA/ELRC3.0 huggingface dataset:
English: It is known that the risk of arterial thromboembolism (ATE) (myocardial infarction, cerebrovascular accident) is also increased with use of CHCs, however there was no evidence for differences between
Danish: Risikoen for arteriel tromboemboli (myokardieinfarkt, cerebrovaskulær hændelse) vides ligeledes at være forhøjet ved brug af kombinerede hormonale kontraceptiva, men der var ikke tegn på forskelle mellem de forskellige kombinerede hormonale kontraceptiva i den relative risiko for arteriel tromboemboli.
English: EMEA/301122/2007-EN
Danish: EMEA/301122/2007-DA
English: The final opinion was converted into a Decision by the European Commission on 13 June 2007.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 13. juni
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II.
Danish: Listen over lægemiddelnavne findes i bilag I. De faglige konklusioner findes i bilag II.
English: The Reference Member State was France and the Concerned Member States were Belgium, the Czech Republic, Germany, Italy, Spain, and the United Kingdom.
Danish: Referencemedlemsstaten var Frankrig, og de berørte medlemsstater var Belgien, Den Tjekkiske Republik, Tyskland, Italien, Spanien og Det Forenede Kongerige.
English: The rapporteur was Dr. J. Schefferlie and the co-rapporteur was Prof. R. Kroker.
Danish: Dr. J. Schefferlie var rapportør, og prof. R. Kroker medrapportør.
English: London, 24 July 2007 EMEA/301122/2007
Danish: London, den 24. juli 2007 EMEA/301122/2007
English: Belgium referred the reason for disagreement to the EMEA on 28 July 2005.
Danish: Belgien fremsendte begrundelserne for uenigheden til EMEA den 28. juli 2005.
English: The arbitration procedure started on 8 September 2005 with the adoption of list of questions.
Danish: Voldgiftsproceduren indledtes den 8. september 2005 med vedtagelsen af en liste med spørgsmål.
English: • the currently authorised withdrawal periods are inadequate to ensure that foodstuffs obtained from the treated animal do not contain residues which might constitute a health hazard to the consumer.
Danish: • De godkendte tilbageholdelsesperioder er for korte til at sikre, at levnedsmidler hidrørende fra behandlede dyr ikke indeholder restkoncentrationer, som kan være sundhedsfarlige for forbrugeren.
English: During their June 2006 meeting, the CVMP appointed Dr. R. Breathnach as rapporteur for the assessment of the grounds for the request for re-examination of the opinion.
Danish: På udvalgets møde i juni 2006 udpegede CVMP dr. R. Breathnach som rapportør for vurderingen af begrundelserne for anmodningen om revurdering af udtalelsen.
English: o in cattle, residue concentration at the injection site were still above the MRL at the last slaughter time point; o in pigs, residue concentrations at the injection site were still above the MRL at the last slaughter time point.
Danish: o I kvæg var restkoncentrationen ved injektionsstedet stadig højere end MRL-værdien ved sidste slagtetidspunkt o I grise var restkoncentrationen ved injektionsstedet stadig højere end MRL-værdien ved sidste slagtetidspunkt.
English: Suramox 15% LA is an injectable suspension containing amoxicillin, which is a beta-lactam antibiotic, belonging to the group of penicillins.
Danish: Suramox 15 % LA er en suspension til injektion, som indeholder amoxicillin, som er et beta-lactam antibiotikum tilhørende penicillingruppen.
English: During the written procedure a request was received from the France for new studies made available by the Marketing Authorisation Holder to be scientifically assessed.
Danish: I løbet af den skriftlige procedure modtog udvalget en anmodning fra Frankrig om gennemførelse af en faglig vurdering af nye undersøgelser, som indehaveren af markedsføringstilladelsen havde fremlagt.
English: In both species the product is administered intramuscularly at a dose rate of 15 mg amoxicillin/kg bw (equivalent to 1 ml of Suramox 15% LA / 10 kg bw) twice at 48 hours interval.
Danish: For begge dyrearters vedkommende gives produktet intramuskulært i en dosis på 15 mg amoxicillin pr. kg legemsvægt (svarende til 1 ml Suramox 15 % LA pr. 10 kg legemsvægt) to gange med 48 timers mellemrum.
English: On 14 November 2006 the European Commission suspended the written procedure and on 16 November 2006, requested the CVMP, to consider the new residue studies in the assessment of the referral and to revise as appropriate the opinion of 13 September 2006.
Danish: Den 14. november 2006 suspenderede Europa-Kommissionen den skriftlige procedure og anmodede den 16. november 2006 CVPM om at behandle de nye restkoncentrationsundersøgelser i vurderingen af indbringelsen og i givet fald at revidere udtalelsen af 13. september 2006.
English: A Marketing Authorisation for Suramox 15% LA was previously granted to Virbac S.A. in France on 6 July 2004 based on an abridged application having Duphamox LA as reference medicinal product, with a withdrawal period of 58 days in cattle for meat and offal and 35 days in pigs for meat and offal.
Danish: Der er tidligere, nemlig den 6. juli 2004, blevet udstedt en markedsføringstilladelse for Suramox 15 % LA til Virbac S.A. i Frankrig på grundlag af en forkortet ansøgning med Duphamox LA som referencelægemiddel, med en tilbageholdelsesperiode på 58 dage for kvæg for kød og indvolde og 35 dage for svin for kød og indvolde.
English: On 1 June 2006, the representative of the MAH notified the EMEA on his intention to request the reexamination of the CVMP opinion in accordance with Article 36(4)2.
Danish: Den 1. juni 2006 meddelte en repræsentant for indehaveren af markedsføringstilladelsen EMEA, at han havde til hensigt at anmode om en revurdering af CVMP's udtalelse i overensstemmelse med artikel 36, stk. 42.
English: The Marketing Authorisation Holder submitted the new residue studies to the CVMP on 9 January 2007 and provided oral explanations to the Committee on 13 March 2007 including presentation of a new residue study in pigs and a new calculation and proposal for the withdrawal period for pigs.
Danish: Den 9. januar 2007 fremlagde indehaveren af markedsføringstilladelsen de nye restkoncentrationsundersøgelser for CVMP og afgav den 13. marts 2007 flere mundtlige redegørelser for udvalget, herunder en ny restkoncentrationsundersøgelse for svin og en ny beregning af og forslag til tilbageholdelsestid for svin.
English: On 13 September 2006 the CVMP, considered the detailed grounds the re-examination of the opinion and confirmed its previous opinion concluding that the marketing authorisations for Suramox 15% LA should be suspended.
Danish: Den 13. september 2006 behandlede CVMP de nærmere begrundelser for revurderingen af udtalelsen og bekræftede sin tidligere udtalelse med den konklusion at markedsføringstilladelsen for Suramox 15 % LA skulle suspenderes.
English: During its March 2007 meeting, the CVMP, considered the new residue studies submitted with regard to Suramox 15% LA and concluded that the new data did not allow establishment of withdrawal periods for edible tissues in cattle and pigs.
Danish: På sit møde i marts 2007 behandlede CVMP de nye forelagte restkoncentrationsundersøgelser vedrørende Suramox 15 % LA og konkluderede, at de nye oplysninger ikke gjorde det muligt at fastsætte tilbageholdelsestider for spiseligt væv fra kvæg og svin.
English: OPINION FOLLOWING AN ARTICLE 351 REFERRAL FOR Suramox 15 % LA and its associated name Stabox 15 % LA International Non-Proprietary Name (INN): Amoxicillin
Danish: UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 351 OM Suramox 15 % LA og tilknyttede navn Stabox 15 % LA Internationalt fællesnavn (INN): Amoxicillin
English: At the request of the MAH the evaluation procedure was suspended on 15 March 2006 in order to allow for the MAH to prepare for the provision of oral explanations.
Danish: Efter anmodning fra indehaveren af markedsføringstilladelsen blev evalueringsproceduren suspenderet den 15. marts 2006, således at indehaveren af markedsføringstilladelsen havde mulighed for at udarbejde mundtlige redegørelser.
English: Therefore the Committee adopted by consensus a revised opinion confirming its previous recommendation for the suspension of the marketing authorizations for Suramox 15% LA and the associated invented name, Stabox 15% LA.
Danish: Derfor vedtog udvalget enstemmigt en revideret udtalelse, der bekræftede dets oprindelige henstilling om at suspendere markedsføringstilladelserne for Suramox 15 % LA og særnavnet Stabox 15 % LA. Følgende begrundelser anførtes:
English: The Marketing Authorisation Holder (MAH) provided written explanations on 16 January 2006.
Danish: Den 16. januar 2006 fremlagde indehaveren af markedsføringstilladelsen en skriftlig redegørelse.
English: The oral explanations were presented on 17 May 2006 by the MAH to the Committee.
Danish: Den 17. maj 2006 afgav indehaveren af markedsføringstilladelsen mundtlige redegørelser for udvalget.
English: The expiry date refers to the last day of that month.
Danish: Udløbsdatoen er den sidste dag i den måned.
English: Further information regarding these two substances is provided below.
Danish: Yderligere oplysninger om disse to stoffer er angivet nedenfor.
English: Date of first authorisation: 19 November 2014 Date of latest renewal:
Danish: Dato for første markedsføringstilladelse: 19. november 2014 Dato for seneste fornyelse:
English: Preferred term
Danish: Foretrukket term
English: - If you have epilepsy.
Danish: - Hvis du har epilepsi.
English: A behavioural intervention program was added to both treatment groups for an additional 4 weeks.
Danish: Der blev tilføjet et adfærdsmæssigt interventionsprogram til begge behandlingsgrupper i yderligere 4 uger.
English: - You can use Brimica Genuair anytime before or after food or drink.
Danish: - Du kan tage Brimica Genuair når som helst før eller efter mad eller drikke.
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 hører 'klikket'.
English: This reaction may rarely occur (may affect up to 1 in 1,000 people).
Danish: Denne bivirkning opstår sjældent (kan forekomme hos op til 1 ud af 1.000 mennesker).
English: Medical attention may be needed.
Danish: Det kan være nødvendigt at modtage lægehjælp.
English: Frequency of this reactin cannot be estimated from the available data.
Danish: Hyppigheden af denne bivirkning kan ikke beregnes ud fra tilgængelige data.
English: [arrow] Tear here
Danish: [arrow] Riv her
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: *As the primary endpoint did not achieve statistical significance, all p-values for secondary endpoints are tested at a nominal significance level of 0.05, and no formal statistical inference can be drawn.
Danish: *Da det primære endepunkt ikke opnåede statistisk signifikans, blev alle p-værdier testet for sekundære endepunkter på et nominelt signifikansniveau på 0,05, og der kan ikke drages nogen formel statistisk konklusion.
English: Hypokalaemia is usually transient, not requiring supplementation.
Danish: Hypokaliæmi er normalt forbigående og kræver ikke supplerende behandling.
English: Both belong to a group of medicines called bronchodilators.
Danish: Begge tilhører en gruppe lægemidler betegnet bronkodilatatorer.
English: Brimica Genuair should only be used during pregnancy if the expected benefits outweigh the potential risks.
Danish: Brimica Genuair bør kun anvendes under graviditet, når de forventede fordele opvejer de potentielle risici.
English: The medicine must be used every day, twice a day and not only when breathing problems or other symptoms of COPD are experienced.
Danish: Medicinen skal anvendes hver dag, to gange om dagen og ikke kun, når du oplever vejrtrækningsproblemer eller andre symptomer på KOL.
English: A video demonstration on how to use the Genuair inhaler is also available on www.genuair.com and through the code below.
Danish: En demonstrationsvideo om hvordan man bruger Genuair inhalator er også tilgængelig på www.genuair.com og via koden nedenfor.
English: Formoterol is eliminated primarily by metabolism.
Danish: Formoterol elimineres primært ved metabolisering.
English: To be used within 60 days of opening the bag.
Danish: Skal anvendes inden for 60 dage efter posen åbnes.
English: • Medicines that lower the amount of potassium in your blood.
Danish: • Medicin, som sænker kaliummængden i dit blod.
English: *Half-life consistent with product accumulation based on a known dose regimen.
Danish: *Halveringstid i overensstemmelse med produktakkumulering baseret på et kendt doseringsregime.
English: The recommended dose is one inhalation twice daily.
Danish: Den anbefalede dosis er én inhalation to gange dagligt.
English: If the control window still does not change to red, you may have forgotten to release the orange button before inhaling, or you may not have inhaled strongly enough.
Danish: Hvis kontrolvinduet stadigvæk ikke skifter til rødt, har du måske glemt at slippe den orange knap før inhalation, eller du har måske ikke inhaleret kraftigt nok.
English: Stop using the medicine and contact your doctor immediately if you:
Danish: Stop med at bruge lægemidlet, og kontakt straks lægen, hvis du:
English: This medicine should not be used for the treatment of asthma.
Danish: Denne medicin må ikke anvendes til behandling af astma.
English: Some side effects may be serious: if you get any of these side effects, tell your doctor immediately.
Danish: Nogle bivirkninger kan være alvorlige: Hvis du får nogle af disse bivirkninger, skal du straks kontakte din læge.
English: The plasma protein binding of formoterol is 61% to 64% (34% primarily to albumin).
Danish: Formoterols plasmaproteinbinding er 61 % til 64 % (34 % primært til albumin).
English: Moreover, post-marketing reports of ‘peripheral oedema' did not show positive re-challenge.
Danish: Derudover viste postmarketingrapporter om "perifert ødem" ikke positiv rechallange.
English: If this occurs, medicinal product should be stopped and other treatment will be considered.
Danish: Hvis dette sker, skal behandlingen stoppes og anden behandling overvejes.
English: - The recommended dose is one inhalation in the morning and one inhalation in the evening.
Danish: - Den anbefalede dosis er én inhalation om morgenen og én inhalation om aftenen.
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: The combination of these substances with different mechanisms of action results in additive efficacy compared to that achieved with either component alone.
Danish: Kombinationen af disse stoffer med forskellige virkningsmekanismer giver anledning til en additiv effekt sammenlignet med den, der opnås med hver komponent for sig.
English: Breathlessness and other symptomatic outcomes:
Danish: Kortåndethed og andre symptomatiske udfald:
English: The presentation of the safety profile is based on the experience with Brimica Genuair and the individual components.
Danish: Præsentationen af sikkerhedsprofilen er baseret på erfaringerne med Brimica Genuair og de enkelte komponenter.
English: • Each time you load a dose by pressing the orange 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 orange knap, flytter dosisindikatoren sig et lille sykke mod det næste tal (50, 40, 30, 20, 10 eller 0).
English: Since aclidinium bromide is quickly broken down in plasma, the level of systemic anticholinergic undesirable effects is low.
Danish: Da aclidiniumbromid nedbrydes hurtigt i plasma, er niveauet af systemiske antikolinerge uønskede virkninger lavt.
English: - If you have difficulty passing urine or problems due to an enlarged prostate.
Danish: - Hvis du har svært ved at lade vandet eller problemer på grund af en forstørret prostata.
English: This section contains information on how to use your Genuair inhaler.
Danish: Denne sektion indeholder information om, hvordan du skal anvende din Genuair inhalator.
English: Bronchospasm, including paradoxical
Danish: Bronkospasme, inklusive paradoks
English: This medicine contains lactose.
Danish: Lægemidlet indeholder lactose.
English: Other side effects which may occur while using Brimica Genuair:
Danish: Andre bivirkninger, som kan forekomme i forbindelse med brug af Brimica Genuair:
English: It is unknown whether aclidinium (and/or its metabolites) or formoterol are excreted in human milk.
Danish: Det er ukendt, om aclidinium (og/eller dets metabolitter) eller formoterol udskilles i human mælk.
English: There are no data available on the use of Brimica Genuair in pregnant women.
Danish: Der er ingen data fra anvendelse af Brimica Genuair til gravide kvinder.
English: Nevertheless, it is considered unlikely that Brimica Genuair administered at the recommended dose will affect fertility in humans.
Danish: Det betragtes dog som usandsynligt, at Brimica Genuair indgivet ved den anbefalede dosis vil påvirke fertiliteten hos mennesker.
English: Mean effective half-lives* observed for both aclidinium and formoterol (based on the accumulation ratio) are approximately 10 hours.
Danish: De gennemsnitlige effektive halveringstider*, som blev observeret for både aclidinium og formoterol (baseret på akkumuleringsratio), er ca. 10 timer.
English: By opening the airways, the medicine helps relieve symptoms such as shortness of breath.
Danish: Ved at åbne luftvejene hjælper medicinen med at lindre symptomer som f.eks. åndenød.
English: Do not use this medicine after the expiry date which is stated on the inhaler label, carton and inhaler bag after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på inhalatorens etiket, karton og pose efter "EXP".
English: If you use Brimica Genuair with some other medicines, the effect of Brimica Genuair or the other medicines may be altered.
Danish: Hvis du bruger Brimica Genuair sammen med visse andre lægemidler, kan virkningen af Brimica Genuair eller de andre lægemidler ændres.
English: Name and address of the manufacturer responsible for batch release Industrias Farmacéuticas Almirall, S.A.
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Industrias Farmacéuticas Almirall, S.A.
English: In case such effects occur, treatment may need to be discontinued.
Danish: Hvis sådanne bivirkninger opstår, kan det være nødvendigt at stoppe behandlingen.
English: When the orange 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 orange knap ikke returnerer helt til udgangspositionen og er låst i en midterposition, har du nået den sidste dosis (Figur O).
English: Hypokalaemia increases susceptibility to cardiac arrhythmias.
Danish: Hypokaliæmi øger tilbøjeligheden til hjertearytmier.
English: Each delivered dose contains approximately 11 mg lactose (as monohydrate).
Danish: Hver afgivet dosis indeholder cirka 11 mg lactose (som monohydrat).
English: Aclidinium is a competitive, selective muscarinic receptor antagonist, with a longer residence time at the M3 receptors than the M2 receptors.
Danish: Aclidinium er en kompetitiv, selektiv muskarin receptorantagonist med en længere opholdstid ved M3-receptorerne end M2-receptorerne.
English: Do not use Brimica Genuair if you notice that the pack is damaged or shows signs of tampering.
Danish: Brug ikke Brimica Genuair, hvis du bemærker, at pakningen er beskadiget, eller der er synlige tegn på manipulering.
English: If a dose is missed, it should be taken as soon as possible and the next dose should be taken at the usual time.
Danish: Hvis en dosis springes over, skal den tages så snart som muligt, og den næste dosis skal tages på det sædvanlige tidspunkt.
English: You should not use this medicine to treat a sudden attack of breathlessness or wheezing.
Danish: Du bør ikke bruge denne medicin til behandling af et pludseligt anfald af kortåndethed eller hvæsen.
English: If you are affected by either of these side effects, do not drive or use machines until the dizziness has cleared or your vision has returned to normal.
Danish: Hvis du er påvirket af en af disse bivirkninger, må du ikke føre motorkøretøjer eller betjene maskiner, før svimmelheden er gået væk, og dit syn er blevet normalt igen.
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: It is important to instruct the patients to read the Instructions for Use in the Package Leaflet.
Danish: Det er vigtigt at instruere patienten i nøje at læse brugsanvisningen i indlægssedlen.
English: If β-adrenergic blockers are required (including eye drops), cardioselective beta-adrenergic blockers are preferred, although they should also be administered with caution.
Danish: Hvis β-adrenerge blokkere (herunder øjendråber) er nødvendige, foretrækkes kardioselektive beta-adrenerge blokkere, selvom de også bør administreres med forsigtighed.
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 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: - The other ingredient is lactose monohydrate (see end of section 2 under ‘Brimica Genuair contains lactose' for more information).
Danish: - Øvrige indholdsstoffer: Lactosemonohydrat (se slutningen af punkt 2 under "Brimica Genuair indeholder lactose" for yderligere information).
English: Brimica Genuair should be discontinued in case of overdose.
Danish: Brimica Genuair bør seponeres i tilfælde af overdosis.
English: • Medicines which can cause a type of change in the electrical activity of the heart known as QT interval prolongation (observed in an electrocardiogram).
Danish: • Medicin, der kan forårsage en type ændring i hjertets elektriske aktivitet, som kaldes forlænget QT-interval (observeres i et elektrokardiogram).
English: There is no saturation of binding sites in the concentration range reached with therapeutic doses.
Danish: Der er ingen mætning af bindingssteder i koncentrationsområdet opnået ved terapeutiske doser.
English: Brimica Genuair contains lactose
Danish: Brimica Genuair indeholder lactose
English: Show the packaging of Brimica Genuair.
Danish: Vis emballagen med Brimica Genuair.
English: - If you have a tumour in one of your adrenal glands (phaeochromocytoma).
Danish: - Hvis du har en svulst i en af dine binyrer (fæokromocytom).
English: These effects are known exaggerated pharmacological responses observed with β2-agonists.
Danish: Disse effekter er kendte overdrevne farmakologiske reaktioner observeret i forbindelse med β2-agonister.
English: The main plasma protein that binds aclidinium is albumin.
Danish: Det primære plasmaprotein, som binder aclidinium, er albumin.
English: In the long-term, dry mouth can be associated with tooth decay, so it is important to pay attention to oral hygiene.
Danish: På lang sigt kan tør mund være forbundet med huller i tænderne, så det er vigtigt at være opmærksom på mundhygiejnen.
English: You should not use Brimica Genuair if you are pregnant or are breast-feeding unless your doctor tells you to do so.
Danish: Du må ikke tage Brimica Genuair, hvis du er gravid eller ammer, medmindre din læge fortæller dig, at du skal gøre det.