FrancophonIA/ELRC3.0 huggingface dataset:
English: After the last dose of rocuronium or vecuronium, at the reappearance of T2, 2 mg/kg sugammadex or 50 mcg/kg neostigmine was administered in a randomised order.
Danish: Efter den sidste dosis af rocuronium eller vecuronium, ved genetablering til T2, blev 2 mg/kg sugammadex eller 50 µg/kg neostigmin administreret i randomiseret orden.
English: A dose of 4 mg/kg sugammadex is recommended if recovery has reached at least 1-2 post-tetanic counts (PTC) following rocuronium or vecuronium induced blockade.
Danish: Der anbefales en dosis på 4 mg/kg sugammadex, hvis genopvågningen efter en rocuronium- eller vecuroniuminduceret blokade har nået mindst 1-2 post-tetanic counts (PTC).
English: Time (minutes) from administration of sugammadex at 3 minutes after rocuronium to recovery of the T4/T1 ratio to 0.9, 0.8 or 0.7
Danish: Tiden (minutter) fra administration af sugammadex 3 minutter efter rocuronium til revertering af T4/ T1 ratioen til 0,9; 0,8 eller 0,7
English: In another pivotal study patients were randomly assigned to the rocuronium or vecuronium group.
Danish: I et andet pivotalt studie fik patienter rocuronium- eller vecuroniumgruppen i randomiseret orden.
English: Sugammadex has not been investigated in patients receiving rocuronium or vecuronium in the ICU setting.
Danish: Anvendelse af sugammadex er ikke undersøgt på intensivafdelinger hos patienter, der får rocuronium eller vecuronium.
English: Excipient(s) with known effect Each mL contains up to 9.7 mg sodium (see section 4.4).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver ml indeholder op til 9,7 mg natrium (se pkt.
English: Light anaesthesia:
Danish: Let anæstesi:
English: In a pivotal study patients were randomly assigned to the rocuronium or vecuronium group.
Danish: I et pivotalt studie fik patienter rocuronium- eller vecuroniumgruppen i randomiseret orden.
English: • Severe slowing of the heart and slowing of the heart up to cardiac arrest may occur when
Danish: Hyppighed ikke kendt • Alvorligt nedsat puls, evt. førende til hjertestop, kan forekomme, når Bridion indgives.
English: Bridion 100 mg/mL injection sugammadex
Danish: Bridion 100 mg/ml injektionsvæske sugammadex i.v.
English: Neostigmine (50 mcg/kg)
Danish: Neostigmin (50 µg/kg)
English: Neostigmine (70 mcg/kg)
Danish: Neostigmin (70 µg/kg)
English: Time (minutes) from administration of sugammadex or neostigmine at deep neuromuscular blockade (1-2 PTCs) after rocuronium or vecuronium to recovery of the T4/T1 ratio to 0.9 Neuromuscular blocking agent
Danish: Tiden (minutter) fra administrering af sugammadex eller neostigmin ved dyb neuromuskulær blokade (1-2 PTC) efter rocuronium eller vecuronium til revertering af T4/ T1 ratioen til 0,9 Neuromuskulær blokker
English: What Bridion contains - The active substance is sugammadex.
Danish: Bridion indeholder: - Aktivt stof: sugammadex
English: Bridion 100 mg/mL solution for injection sugammadex
Danish: Bridion 100 mg/ml injektionsvæske, opløsning sugammadex
English: Treatment regimen Rocuronium and sugammadex (16 mg/kg)
Danish: Behandlingsregime Rocuronium og sugammadex (16 mg/kg)
English: Elimination half-life (hr)
Danish: Eliminationshalveringstid (timer)
English: Obese patients:
Danish: Overvægtige patienter:
English: Treatment regimen Sugammadex (4 mg/kg)
Danish: Behandlingsregime Sugammadex (4 mg/kg)
English: Metabolism:
Danish: Biotransformation:
English: OUTER CARTON, 10 x 2 mL vials
Danish: YDRE KARTON, 10 x 2 ml hætteglas
English: 1 mL contains 100 mg sugammadex (as sugammadex sodium).
Danish: 1 ml indeholder 100 mg sugammadex (som sugammadexnatrium).
English: OUTER CARTON, 10 x 5 mL vials
Danish: YDRE KARTON, 10 x 5 ml hætteglas
English: Treatment regimen Sugammadex (2 mg/kg)
Danish: Behandlingsregime Sugammadex (2 mg/kg)
English: Time (minutes) from administration of sugammadex or neostigmine at reappearance of T2 after rocuronium or vecuronium to recovery of the T4/T1 ratio to 0.9
Danish: Tiden (minutter) fra administration af sugammadex eller neostigmin ved genetablering af T2 efter rocuronium eller vecuronium til revertering af T4/T1 ratioen til 0,9
English: • If you get any side effects, talk to your anaesthetist or other doctor.
Danish: • Tal med din anæstesilæge eller anden læge, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: Effect on haemostasis:
Danish: Effekt på hæmostase:
English: Each vial of 5 mL contains 500 mg sugammadex (as sugammadex sodium).
Danish: Hvert 5 ml hætteglas indeholder 500 mg sugammadex (som sugammadexnatrium).
English: Treatment regimen Rocuronium and sugammadex (2 mg/kg)
Danish: Behandlingsregime Rocuronium og sugammadex (2 mg/kg)
English: Airway Complication of Anaesthesia:
Danish: Luftvejskomplikation forårsaget af anæstesi:
English: Bridion will be given to you by your anaesthetist.
Danish: Sådan får du Bridion Du får Bridion af anæstesilægen.
English: 1 mL contains sugammadex sodium equivalent to 100 mg sugammadex.
Danish: 1 ml indeholder sugammadexnatrium svarende til 100 mg sugammadex.
English: Adult
Danish: Ældre
English: Each vial of 2 mL contains 200 mg sugammadex (as sugammadex sodium).
Danish: Hvert 2 ml hætteglas indeholder 200 mg sugammadex (som sugammadexnatrium).
English: Each vial of 5 mL contains sugammadex sodium equivalent to 500 mg sugammadex.
Danish: Hvert 5 ml hætteglas indeholder sugammadexnatrium svarende til 500 mg sugammadex.
English: If you have any further questions on the use of this medicine, ask your anaesthetist or other doctor.
Danish: Spørg anæstesilægen eller anden læge, hvis der er noget vedrørende medicinen, du er i tvivl om.
English: In the exceptional situation of recurrence of neuromuscular blockade post-operatively (see section 4.4) after an initial dose of 2 mg/kg or 4 mg/kg sugammadex, a repeat dose of 4 mg/kg sugammadex is recommended.
Danish: 4.4) efter en initial dosis på 2 mg/kg eller 4 mg/kg sugammadex anbefales en gen-administration af sugammadex på 4 mg/kg.
English: VIAL LABEL, 10 x 5 mL vials
Danish: ETIKET TIL HÆTTEGLAS, 10 x 5 ml
English: 1 mL solution for injection contains sugammadex sodium equivalent to 100 mg sugammadex.
Danish: 1 ml injektionsvæske, opløsning indeholder sugammadexnatrium svarende til 100 mg sugammadex.
English: Each vial of 2 mL contains sugammadex sodium equivalent to 200 mg sugammadex.
Danish: Hvert 2 ml hætteglas indeholder sugammadexnatrium svarende til 200 mg sugammadex.
English: VIAL LABEL, 10 x 2 mL vials
Danish: ETIKET TIL HÆTTEGLAS, 10 x 2 ml
English: The following adverse reactions were reported in placebo controlled trials where subjects received anaesthesia and/or neuromuscular blocking agents (1,078 subject exposures to sugammadex versus 544 to placebo): [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)]
Danish: Følgende bivirkninger blev rapporteret i placebokontrollerede studier, hvor forsøgspersonerne fik anæstetika og/eller neuromuskulære blokkere (1.078 forsøgspersoner fik sugammadex, og 544 fik placebo):
English: 15 yrs
Danish: 15 år
English: Sugammadex is not metabolised nor excreted by the liver; therefore dedicated studies in patients with hepatic impairment have not been conducted.
Danish: Sugammadex bliver ikke metaboliseret i eller udskilt via leveren.
English: Intravenous use
Danish: PRODUKTRESUMÉ
English: 40 yrs
Danish: Voksne Normal 40 år
English: Frequency not known
Danish: Ikke almindelig
English: 7 yrs
Danish: Børn Normal 7 år
English: Invented name Strength Pharmaceutical Form
Danish: Særnavn Styrke Lægemiddelform
English: 30 ml (10 mg/ml)
Danish: 30 ml (10 mg/ml) 1 hætteglas
English: 300 mg Concentrate for solution for infusion
Danish: Soliris 300 mg Koncentrat til infusionsvæske, opløsning
English: Intravenous use Vial (glass)
Danish: Til intravenøs anvendelse Hætteglas (glas)
English: Content (concentration) Package size
Danish: Indhold (Koncentration)
English: 13 July 2011
Danish: 13 juli 2011
English: The final opinion was converted into a Decision by the European Commission on 13 July 2011.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 13 juli
English: The referral procedure started on 14 July 2010.
Danish: Indbringelsesproceduren blev indledt den 14. juli 2010.
English: Written explanations were provided by the applicant/marketing authorisation holder on 29 October 2010 and 8 March 2011.
Danish: Ansøgeren/indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 29. oktober 2010 og den 8. marts 2011.
English: The Committee appointed Mrs Ruth Kearsley as rapporteur and Dr Jiří Bureš as co-rapporteur.
Danish: Udvalget udpegede Ruth Kearsley som rapportør og dr. Jiří Bureš som medrapportør.
English: International non-proprietary name (inn): doxycycline hyclate
Danish: Internationalt fællesnavn (INN): doxycyclinhyclat
English: Further to the resignation of Mrs Ruth Kearsley as CVMP member, Ms Helen Jukes was appointed to replace her and took over the rapporteurship.
Danish: Da Ruth Kearsley trådte tilbage som CVMP-medlem, blev Helen Jukes udpeget til at erstatte hende og overtog hvervet som rapportør.
English: Tetracyclines have broad spectrum activity inhibiting Gram-positive and Gram-negative bacteria, mycoplasmas, chlamydiae, rickettsias and some protozoa.
Danish: Tetracykliner har et bredt aktivitetsspektrum, som hæmmer Gram-positive og Gram-negative bakterier, mycoplasmer, chlamydiae, rickettsier og visse protozoer.
English: Doxycycline 50% WSP and associated names is a powder for use in drinking water containing the active substance doxycycline hyclate 500 mg/g.
Danish: Doxycyclin 50% WSP og relaterede navne er et pulver til anvendelse i drikkevand, der indeholder det aktive stof doxycyclinhyclat 500 mg/g.
English: In pigs and pre-ruminant calves the product is indicated for the treatment of certain infections of the respiratory tract.
Danish: Hos svin og prædrøvtyggende kalve er lægemidlet indiceret til behandling af visse luftvejsinfektioner.
English: Due to divergent national decisions taken by Member States regarding the target species, indications, amounts to be administered and withdrawal periods concerning the authorisation of Doxycycline 50% WSP and associated names, on 18 June 2010 the United Kingdom referred the issue to the CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve divergences amongst the nationally authorised summary of product characteristics across the European Union.
Danish: På grund af de forskellige nationale beslutninger i medlemsstaterne, hvad angår dyrearter, som lægemidlet er beregnet til, indikationer, doseringer og tilbageholdelsestider i forbindelse med godkendelsen af Doxycyclin 50% WSP og relaterede navne, henviste Det Forenede Kongerige den 18. juni 2010 sagen til CVMP i henhold til artikel 34, stk. 1, i direktiv 2001/82/EF for at løse divergenserne mellem de nationalt godkendte produktresuméer i EU.
English: Based on the rapporteurs' assessment of the currently available data, the CVMP considered that the benefit/risk profile for Doxycycline 50% WSP and associated names remains positive subject to variation of the marketing authorisations in accordance with the summary of product characteristics, and therefore adopted a positive opinion on 4 May 2011.
Danish: På baggrund af rapportørernes vurdering af de aktuelt tilgængelige data var CVMP af den opfattelse, at benefit/risk-profilen for Doxycyclin 50% WSP og relaterede navne fortsat er positiv som følge af ændringen af markedsføringstilladelserne i overensstemmelse med produktresuméet, og CVMP vedtog således en positiv udtalelse den 4. maj 2011.
English: Doxycycline is a semi-synthetic tetracycline antibiotic.
Danish: Doxycyclin er et semisyntetisk antibiotikum af tetracyclintypen.
English: In chickens the product is indicated for named infections of the respiratory tract and the alimentary tract.
Danish: Hos høns er lægemidlet indiceret til behandling af visse luftvejs- og mave-tarm-infektioner.
English: ANNEX II
Danish: Bilag II
English: Overall summary of the scientific evaluation of Iffeza and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Iffeza og relaterede navne (se bilag I)
English: • The Committee considered the notification of the referral triggered by the United Kingdom under Article 29(4) of Council Directive 2001/83/EC.
Danish: • Udvalget behandlede anmeldelsen af den indbringelse, der var indledt af Det Forenede Kongerige i henhold til artikel 29, stk. 4, i Rådets direktiv 2001/83/EF.
English: Pharmacokinetic (PK) data
Danish: Farmakokinetiske (PK) data
English: The total programme comprised 18 completed studies and included almost 5000 patients.
Danish: Programmet bestod af i alt 18 fuldførte undersøgelser, der omfattede næsten 5 000 patienter.
English: None of the submitted clinical trials were of such duration.
Danish: Ingen af de forelagte kliniske undersøgelser var af en sådan varighed.
English: Predictive value of the FEV1 data
Danish: Den prædiktive værdi af FEV-data
English: • The Committee considered that the overall safety and efficacy have been sufficiently proven by the studies presented.
Danish: • Udvalget fandt, at den overordnede sikkerhed og virkning er tilfredsstillende godtgjort med de forelagte undersøgelser.
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR POSITIVE OPINION
Danish: Videnskabelige konklusioner og begrundelse for den positive udtalelse
English: Again a similar pattern was evident from the Applicant's own long-term study.
Danish: Samme mønster fremgik af ansøgerens egen langsigtede undersøgelse.
English: Asthma control and exacerbations
Danish: Astmakontrol og eksacerbationer
English: Moreover it was proposed that “severe” exacerbations are the most discriminative exacerbations variable.
Danish: Desuden blev det fremført, at “svære” eksacerbationer er den mest diskriminative variabel vedrørende eksacerbationer.
English: However, the Applicant has found no evidence to support such a view in the literature.
Danish: Ansøgeren har imidlertid ikke fundet holdepunkt for denne antagelse i litteraturen.
English: • The Committee reviewed all available data submitted by the applicant to address the potential serious risk to public health, in particular the efficacy in respect of long-term asthma control.
Danish: • Udvalget gennemgik alle data, der var forelagt af ansøgeren vedrørende den potentielle alvorlige risiko for den offentlige sundhed, navnlig produktets virkning i form af langsigtet astmakontrol.
English: The five pivotal Iffeza Phase III studies included approximately 2500 patients and the safety database includes over 1900 Iffeza-treated patients.
Danish: De fem fase III-hovedundersøgelser med Iffeza omfattede ca. 2 500 patienter, og sikkerhedsdatabasen omfatter over 1 900 patienter behandlet med Iffeza.
English: Asthma control is one of two principal treatment goals in asthma management (the other being the reduction of exacerbation risk).
Danish: Astmakontrol er det ene af de to hovedmål for astmabehandling (det andet er reduktion af eksacerbationsrisiko).
English: These include two published studies which specifically recruited patients with a history of recent exacerbations and which were conducted over 6 to 12 months (Ind 2003; Verona 2003).
Danish: Heriblandt er der to publicerede undersøgelser, der specifikt omfattede patienter med nylige eksacerbationer og havde en varighed på 6-12 måneder (Ind, 2003; Verona, 2003).
English: This hypothesis has in turn led to concerns regarding the duration of the Applicant's 8 to 12 week studies.
Danish: Denne hypotese har igen medført betænkeligheder ved varigheden af ansøgerens undersøgelser (8-12 uger).
English: To distinguish a potential difference a study with a long duration e.g. 6-12 months is necessary.
Danish: Påvisning af en eventuel forskel kræver en undersøgelse af lang varighed, f.eks. 6-12 måneder.
English: The clinical development programme for Iffeza was set up to evaluate efficacy and safety in the intended patient population.
Danish: Formålet med det kliniske udviklingsprogram for Iffeza var at vurdere virkningen og sikkerheden i den tilsigtede patientpopulation.
English: The leading global expert respiratory group (ATS/ERS) has recently proposed standardised definitions of clinically relevant exacerbations for use in future trials.
Danish: Den førende globale ekspertgruppe vedrørende luftveje (ATS/ERS) har for nylig foreslået standardiserede definitioner af klinisk relevante eksacerbationer til brug i kliniske studier.
English: Across a broad range of endpoints such as discontinuation due to lack of efficacy, symptom-free days and nights and the amount of rescue medication, the size of effect seen is clinically important.
Danish: For et bredt udsnit af endepunkter såsom seponering pga. manglende virkning, symptomfrie dage og nætter samt forbrug af PN-medicin er virkningen klinisk væsentlig.
English: With regard to the suggestion that “severe” exacerbations are the optimal variable with which to examine potential differences in inhaled corticosteroid effect, the applicant commented that literature does not support this view.
Danish: Vedrørende formodningen om, at “svære” eksacerbationer er den optimale variabel for undersøgelse af mulige forskelle i inhalationskortikosteroiders virkning, bemærkede ansøgeren, at litteraturen ikke giver holdepunkt herfor.
English: Published sources indicate that these treatment differences would at worst remain static and at best improve in favour of Iffeza over the longer-term.
Danish: Publicerede kilder viser, at disse behandlingsbetingede forskelle på længere sigt i værste tilfælde vil være uændrede, og i bedste tilfælde vil ændres til fordel for Iffeza.
English: It is a multidimensional concept incorporating symptoms, night time awakenings, use of rescue medication, lung function and activity limitation.
Danish: Det er et multidimensionalt begreb, der indbefatter symptomer, natlige opvågninger, brug af PN-medicin og begrænsninger i lungefunktion og aktivitet.
English: This provides further support for the clinical relevance of the effects seen with Iffeza.
Danish: Dette støtter yderligere den kliniske relevans af de fundne virkninger af Iffeza.
English: Following oral inhalation of formoterol the onset of bronchodilatation is rapid, within 1 - 3 minutes, and bronchodilatation following a single dose lasts for 12 hours.
Danish: Efter inhalation af formoterol indtræder bronkiedilatation i løbet af 1-3 minutter og vedvarer i 12 timer efter en enkelt dosis.
English: Nor does the literature offer any support for the notion that the exacerbations captured within the Applicant's clinical studies might not be adequate.
Danish: Ligeledes giver litteraturen ikke holdepunkt for, at de registrerede eksacerbationer i ansøgerens kliniske undersøgelser ikke skulle være dækkende.
English: The indication sought is the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting β2 agonist) is appropriate:
Danish: Den ansøgte indikation er regelmæssig behandling af astma, hvor et kombinationsprodukt (et inhalationskortikosteroid og en langtidsvirkende β2-agonist) er hensigtsmæssig:
English: With regard to the duration of the pivotal studies (8-12 weeks), literature data support the view that treatment effects upon asthma control variables are maximal within 3 months and sustained thereafter.
Danish: Vedrørende hovedundersøgelsernes varighed (8-12 uger) giver litteraturdata støtte for, at behandlingsvirkningen på astmakontrol-variablene er maksimal efter tre måneder og derefter vedvarer.
English: In addition to the above is the observation from several published studies that FEV1 is maximal following approximately 8 to 12 weeks inhaled corticosteroid-based treatment and is stable thereafter.
Danish: I tilslutning til ovenstående viser flere publicerede undersøgelser, at FEV1 er maksimal efter ca. otte til tolv ugers kortikosteroidbaseret behandling og derefter er stabil.
English: In both claimed indications the previously used inhaled corticosteroid (ICS) is replaced by the inhaled corticosteroid in Iffeza for which such proof is required.
Danish: Til begge de ansøgte indikationer er det tidligere anvendte inhalationskortikosteroid (ICS) erstattet med inhalationskortikosteroidet i Iffeza, og dette nødvendiggør en sådan påvisning.
English: This endpoint (i.e. change in FEV1 from pre-dose at baseline) was designated a priori as the primary endpoint to assess corticosteroid effect.
Danish: Dette endepunkt (dvs. ændring i FEV1 fra baseline-værdien før dosering) var på forhånd udpeget som det primære endepunkt for vurdering af kortikosteroid virkning.
English: In studies comparing a two-fold dose multiple of fluticasone propionate, dose response for exacerbations has never been shown.
Danish: I undersøgelser, der sammenligner to forskellige doser af fluticasonpropionat, er der aldrig fundet dosisrespons på eksacerbationer.
English: Fluticasone propionate has been shown to reduce symptoms and exacerbations of asthma and to decrease airway reactivity to histamine and methacholine in patients with hyperreactive airways.
Danish: Fluticasonpropionat reducerer symptomer og eksacerbationer ved astma og mindsker luftvejenes reaktivitet over for histamin og metakolin hos patienter med hyperreaktive luftveje.
English: The development programme also assessed the efficacy and safety of Iffeza administered either with or without a spacing device and investigated the efficacy and safety of Iffeza across relevant subgroups.
Danish: I udviklingsprogrammet vurderedes endvidere virkningen og sikkerheden af Iffeza administreret med og uden afstandsstykke samt virkningen og sikkerheden af Iffeza i relevante undergrupper.
English: Supportive studies compared the efficacy and safety of Iffeza with other combination therapies.
Danish: I de støttende undersøgelser blev virkningen og sikkerheden af Iffeza sammenlignet med andre kombinationsbehandlinger.
English: The pivotal clinical studies were designed to compare the efficacy and safety of Iffeza with its individual components administered separately and with its individual components administered together but inhaled from separate inhalers.
Danish: De kliniske hovedundersøgelser havde til formål at sammenligne virkningen og sikkerheden af Iffeza dels når dets enkelte komponenter blev administreret hver for sig, dels når dets enkelte komponenter blev administreret hver for sig, men inhaleret fra separate inhalatorer.
English: The Applicant should discuss this concern in the light of the relatively short duration of the clinical study and the fact that the formoterol fumarate component in this fixed-dose combination might have masked a loss of control by controlling symptoms and bronchodilatation.”
Danish: Ansøgeren bør tage stilling hertil på baggrund af den relativt korte varighed af den kliniske undersøgelse og det forhold, at formoterolfumarat-komponenten af den faste kombination kan tænkes at have maskeret manglende kontrol ved at kontrollere symptomer og bronkiedilatation”.
English: The Applicant stated that the choice of this endpoint is consistent with the Note for Guidance on Clinical Investigation of Medicinal Products for Treatment of Asthma - CPMP/EWP/2922/01); it is accepted as an appropriate endpoint to measure inhaled corticosteroid effect as per the CHMP OIP Guideline (CPMP/EWP/4151/00 Rev.1); and it is advocated as an essential endpoint in asthma studies by a joint expert committee of the American Thoracic Society and European Respiratory Society (ATS/ERS).
Danish: Ansøgeren bemærkede, at valget af dette endepunkt er i overensstemmelse med “Note for Guidance on Clinical Investigation of Medicinal Products for Treatment of Asthma” - CPMP/EWP/2922/01), at det er accepteret som et velegnet endepunkt til bestemmelse af inhalationskortikosteroiders virkning i henhold til CHMP's vejledning for inhalationsprodukter (CPMP/EWP/4151/00 Rev.1), og at det anbefales som et essentielt endepunkt i astmaundersøgelser af et fælles ekspertudvalg i American Thoracic Society and European Respiratory Society (ATS/ERS).
English: Masking of any lesser clinical corticosteroid effect by the long-acting ß2 agonist
Danish: Muligheden af, at en eventuel mindre klinisk kortikosteroidvirkning maskeres af den langtidsvirkende ß2-agonist