FrancophonIA/ELRC3.0 huggingface dataset:
English: This case occurred during a clinical trial and highlights the problems with the application of sprayable fibrin sealants during endoscopic procedures, where it is not always feasible to judge distances (such as 4cm) accurately when spraying.
Danish: Dette tilfælde, der forekom i en klinisk undersøgelse, belyser problemerne ved spraypåføring af fibrinklæbere under endoskopiske procedurer, hvor afstanden til målvævet (såsom 4 cm) i praksis ikke altid kan bedømmes nøjagtigt, når der sprayes.
English: • The Committee considered all the cases of air embolism associated with the use of Quixil by spray application that have been reported and concluded that the risk minimisation measures previously implemented were insufficient to mitigate the identified risk of air embolism associated with the use of the Quixil spray application;
Danish: • udvalget tog hensyn til alle indberettede tilfælde af luftemboli relateret til anvendelse af Quixil ved spraypåføring og konkluderede, at de tidligere gennemførte risikominimeringsforanstaltninger var utilstrækkelige til at afbøde den konstaterede risiko for luftemboli ved anvendelse af Quixil ved spraypåføring
English: During the Article 31 procedure, the CHMP also noted a new case of gas embolism reported with the use of Evicel during laser prostatectomy.
Danish: Under artikel 31-proceduren konstaterede CHMP desuden et nyindberettet tilfælde af gasemboli, hvor Evicel blev anvendt under laserprostatektomi.
English: In particular, the MAH was requested to submit an EU risk management plan to the national competent authorities which includes the safety concern of gas embolism and to ensure that all users of the spray application are provided with adequate educational material on the correct use of the product and are offered an educational program which teaches the content of the mentioned educational material.
Danish: Herunder blev indehaveren af markedsføringstilladelsen anmodet om for de nationale kompetente myndigheder at forelægge en EU-risikostyringsplan, der indbefatter den sikkerhedsmæssige betænkelighed vedrørende gasemboli, og at sikre, at alle brugere af spraypåføring får udleveret passende uddannelsesmateriale om korrekt brug af produktet og tilbydes et uddannelsesprogram med instruktion i indholdet af dette materiale.
English: Quixil is indicated as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis.
Danish: Quixil er indiceret som støttebehandling til forbedring af hæmostase ved operative indgreb, hvor sædvanlige kirurgiske teknikker er utilstrækkelige.
English: In addition, the MAH should ensure that all users of the spray application of this product are provided with labels for the pressure regulator that inform about the correct pressure and distance in open surgery, a warning card that informs about the correct pressure and distance for the spray application for open surgery and a yellow tag, to be placed on the device air hose, which provides instructions for use.
Danish: Desuden skal indehaveren af markedsføringstilladelsen drage omsorg for, at alle, der anvender dette produkt ved spraypåføring, modtager etiketter til trykregulatoren med oplysninger om korrekt tryk og korrekt sprøjteafstand ved åbne kirurgiske indgreb, et advarselskort med information om korrekt sprøjtetryk og sprøjteafstand under åbne kirurgiske indgreb og en gul etiket, der skal anbringes på anordningens trykluftslanger og er forsynet med anvisninger for brug.
English: The MAH also provided responses to a request from the CHMP to discuss the merits and feasibility of any risk minimisation measures which could be introduced in order to improve the benefit/risk of the Quixil spray application.
Danish: Indehaveren af markedsføringstilladelsen besvarede desuden en anmodning fra CHMP om at gennemgå fordele og praktisk gennemførlighed af alle risikominimeringsforanstaltninger, der kan tænkes indført for at forbedre benefit/risk-forholdet for spraypåføring af Quixil.
English: The CHMP reviewed all cases of gas embolism reported with the use of sprayable fibrin sealants.
Danish: CHMP gennemgik alle indberettede tilfælde af gasemboli ved spraypåføring af fibrinklæbere.
English: Furthermore, the device design should have a specific gas pressure governor to be used with the spray applicator and with a limit not above the maximal optimal pressure recommended.
Danish: Desuden bør anordningen forsynes med en sæ gastrykregulator, der anvendes sammen med sprayapplikatoren og begrænser trykket til en værdi, der ikke overstiger det anbefalede maksimale optimale tryk.
English: With regard to the efficacy of sprayable fibrin sealants, the CHMP assessed the available information, including data submitted by the MAH.
Danish: Vedrørende virkningen af fibrinklæbere til påsprøjtning vurderede CHMP de foreliggende oplysninger, herunder oplysninger fra indehaveren af markedsføringstilladelsen.
English: Having considered all the available data, including the MAH responses provided in writing and during oral explanations and the conclusions of the Ad-hoc Expert meeting, the CHMP agreed that the benefitrisk balance of Quixil as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis, remains positive under normal conditions of use, subject to the changes to the product information, (see Annex III), together with the agreed risk minimisation measures (see Annex IV) and the agreed Direct Healthcare Professionals Communication.
Danish: Efter gennemgang af de foreliggende data, herunder besvarelserne fra indehaveren af markedsføringstilladelsen, dels skriftligt, dels ved de mundtlige fremlæggelse, og konklusionerne fra ad hoc-ekspertgruppens møde, afgjorde CHMP, at benefit/risk-forholdet for Quixil som støttebehandling til forbedring af hæmostase ved kirurgiske indgreb, hvor sædvanlige kirurgiske teknikker er utilstrækkelige, fortsat er positivt under normale anvendelsesbetingelser, forudsat at produktinformationen ændres (jf. bilag III), at der gennemføres de vedtagne risikominimeringsforanstaltninger (jf. bilag IV), og at der udsendes den vedtagne direkte meddelelse til sundhedspersoner.
English: Moreover, the CHMP concluded that there was insufficient evidence to substantiate a higher risk of air embolus for Quixil (relative to Evicel) because of the different pressure range required for Quixil.
Danish: Desuden konkluderede CHMP, at der ikke var tilstrækkelig evidens for, at risikoen for luftemboli skulle være højere med Quixil end med Evicel, fordi der kræves et andet trykområde for Quixil.
English: • The CHMP agreed on a number of additional risk minimisation measures, including changes to the product information regarding the use of the product as well as educational materials and training to be provided to users of the product, which adequately addressed the identified risk of air embolism;
Danish: • CHMP vedtog en række supplerende risikominimeringsforanstaltninger, der tilstrækkeligt imødegik den konstaterede risiko for luftemboli, herunder ændring af produktinformationen vedrørende produktets anvendelse samt uddannelsesmateriale og oplæring til brugerne af produktet
English: The CHMP noted that the difference in composition between Quixil and Evicel results in a higher viscosity for Quixil, which in turn has the consequence that more force is required to deliver spray application of Quixil.
Danish: CHMP bemærkede, at Quixil på grund af forskellen i sammensætning har højere viskositet end Evicel, hvorfor Quixil kræver større kraft for at afgives ved spraypåføring.
English: Regarding the clinical use of the product, the CHMP was of the opinion, based on the last case of air embolism that was reported during an endoscopy procedure, where the surgeon has limited visibility of the tissue surface that the use of Quixil by spray application should only be considered if it is possible to accurately judge the spraying distance.
Danish: På baggrund af det seneste indberettede tilfælde af luftemboli ved en endoskopisk procedure, hvor kirurgens overblik over vævsoverfladen var begrænset, var det CHMP's opfattelse, at klinisk anvendelse af Quixil ved spraypåføring kun bør overvejes, hvis sprayafstanden kan bedømmes nøjagtigt.
English: Based on the above, the European Commission initiated a procedure under Article 20 of Regulation (EC) No 726/2004 on 21 May 2012, requesting the CHMP to assess the above concerns and their impact on the benefit-risk for Evicel, to give its opinion on measures necessary to ensure the safe and effective use of Evicel and on whether the marketing authorisation for this product should be maintained, varied, suspended or withdrawn.
Danish: Kommissionen anmodede herunder CHMP om at vurdere ovennævnte betænkeligheder og konsekvenserne heraf for benefit/risk-forholdet for Evicel og at fremsætte en udtalelse om behovet for foranstaltninger, der kan garantere sikker og effektiv anvendelse af Evicel, og om, hvorvidt markedsføringstilladelsen for produktet bør opretholdes, ændres, suspenderes eller inddrages.
English: If spraying is required, a pressure regulator has to be used with pressurized CO2 or compressed air. From 2008 until May 2012, four cases of life-threatening air embolism were reported for the spray application of Quixil (of which one had a fatal outcome but without any product being administered).
Danish: Fra 2008 til maj 2012 blev der indberettet fire tilfælde af livstruende luftemboli ved spraypåføring af Quixil (hvoraf det ene fik dødelig udgang, uden at der var administreret noget produkt).
English: The CHMP noted that despite the different recommended pressure regulator settings fibrin sealant spray systems may have similar gas velocity.
Danish: CHMP bemærkede, at systemer til spraypåføring af fibrinklæbere godt kan have samme gashastighed uanset forskelle i det anbefalede indstillingstryk for trykregulatoren.
English: • The Committee, as a consequence, concluded that the benefit-risk balance of Quixil as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis, is positive under normal conditions of use, subject to the agreed risk minimisation measures, including changes to the product information.
Danish: • udvalget konkluderede følgelig, at benefit/risk-forholdet for spraypåføring af Quixil som støttebehandling til forbedring af hæmostase ved kirurgiske indgreb, hvor sædvanlige kirurgiske teknikker er utilstrækkelige, er positivt under normale anvendelsesbetingelser, forudsat at de vedtagne risikominimeringsforanstaltninger gennemføres, herunder ændringer af produktinformationen anbefalede CHMP ændring af betingelserne for markedsføringstilladelserne for de i bilag I anførte lægemidler i overensstemmelse med de ændringer af produktresuméet og indlægssedlen, der fremgår af bilag III, og på de betingelser, der er angivet i bilag IV.
English: In conclusion, having considered the available data, the MAH's responses and taking into account the ad-hoc advisory group recommendations, the CHMP identified and agreed upon a number of risk minimisation measures to be implemented by the MAH to reduce the risk of air/gas embolism associated with sprayable fibrin sealants.
Danish: Som konklusion udpegede og vedtog udvalget en række risikominimeringsforanstaltninger, der skal gennemføres af indehaveren af markedsføringstilladelsen for at mindske risikoen for luft-/gasemboli ved spraypåføring af fibrinklæbere.
English: The analysis of the case reports showed that symptomatic air/gas embolism had occurred only when the instructions for use were not followed; in each of the other cases there was a failure to follow at least one of the current guidelines on administration of spray application of Quixil using pressurised gas: 1.
Danish: I alle de øvrige tilfælde var der tale om manglende overholdelse af mindst én af de gældende retningslinjer for spraypåføring af Quixil med gas under tryk: 1. uhensigtsmæssig afstand til vævsoverfladen 2. for højt tryk 3. anvendelse mod åbne kar eller i stærkt vaskulariserede hulrum, f.eks. knoglemarv.
English: Your doctor will decide if Tredaptive is right for you.
Danish: Lægen vil beslutte, om Tredaptive er rigtigt for Dem.
English: An apparent hypersensitivity reaction has been reported (< 1 %).
Danish: Der er rapporteret om en tilsyneladende overfølsomhedsreaktion (< 1 %).
English: The name of your medicine is Tredaptive.
Danish: Navnet på Deres medicin er Tredaptive.
English: In addition, one or more of the following symptoms have been reported as part of an allergic reaction to Tredaptive.
Danish: Desuden er en eller flere af følgende symptomer set som del af en allergisk reaktion over for Tredaptive.
English: • Take Tredaptive with food.
Danish: • Tag Tredaptive sammen med mad.
English: • Age > 70 years
Danish: • Alder > 70 år.
English: • It is important to follow the advice given in section 3 How to take Tredaptive.
Danish: • Det er vigtigt, at De følger vejledningen i afsnit 3 Sådan skal De tage Tredaptive.
English: • Take Tredaptive once a day, in the evening or at bedtime.
Danish: • Tag Tredaptive én gang dagligt, om aftenen eller ved sengetid.
English: Tredaptive with food, drink and alcohol
Danish: Brug af Tredaptive sammen med mad, drikke og alkohol
English: • when you cannot tolerate a statin or when a statin is not recommended for you.
Danish: • når De ikke kan tåle et statin, eller når De ikke må få et statin.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/459/012
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/459/012
English: Efficacy and safety of Tredaptive in combination with simvastatin > 40 mg were not included in this study.
Danish: Tredaptives sikkerhed og effekt i kombination med simvastatin > 40 mg var ikke inkluderet i denne undersøgelse.
English: Warnings and precautions Tell your doctor about all of your medical conditions.
Danish: Advarsler og forsigtighedsregler Fortæl lægen om Deres helbredstilstand.
English: Some people get dizzy after taking Tredaptive.
Danish: Nogle mennesker kan føle sig svimle, efter de har taget Tredaptive.
English: • a sudden serious allergic reaction (anaphylactic shock).
Danish: • En pludselig alvorlig, allergisk reaktion (anafylaktisk shock).
English: It is not known if Tredaptive will harm your unborn baby.
Danish: Det er ukendt, om Tredaptive kan skade Deres ufødte barn.
English: Do not take Tredaptive if
Danish: Tag ikke Tredaptive hvis
English: Daily doses greater than 2000 mg/40 mg have not been studied and therefore are not recommended.
Danish: Daglige doser over 2.000 mg/40 mg er ikke undersøgt og bør derfor ikke anvendes.
English: Laropiprant is highly bound (> 99 %) to plasma proteins, and its binding is independent of concentration.
Danish: Laropiprant er i høj grad (>99 %) bundet til plasmaproteiner, og dets binding er uafhængig af koncentrationen.
English: Side effects of Tredaptive are:
Danish: Tredaptives bivirkninger er:
English: Therefore, Tredaptive should not be used during pregnancy unless clearly necessary.
Danish: Tredaptive bør derfor ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: Therefore, patients with a risk for hypophosphatemia should be closely followed.
Danish: Derfor bør patientermed risiko for at få hypofosfatæmi følges tæt.
English: Cases of overdose have been reported; the maximum dose of Tredaptive taken was 5,000 mg/100 mg. All patients recovered without sequelae.
Danish: Der er rapporteret om tilfælde af overdosering; den højeste dosis, der var taget, var 5.000 mg/100 mg. Alle patienterne kom sig uden følgevirkninger.
English: The placebo-adjusted LDL-C, HDL-C and TG responses appeared greater among women compared to men and appeared greater among elderly patients (≥ 65 years) compared to younger patients (< 65 years).
Danish: Placebojusteret respons for LDL-C, HDL-C og TG forekom højere hos kvinder end hos mænd og forekom højere hos ældre patienter (≥ 65 år) end hos yngre patienter (< 65 år).
English: If you get dizzy, you should avoid driving or operating machines after taking Tredaptive.
Danish: Hvis De bliver svimmel, skal De undgå at køre bil eller betjene maskiner, efter De har taget Tredaptive.
English: • medicines used to lower blood pressure.
Danish: • Medicin til at sænke blodtrykket.
English: Talk with your doctor before taking Tredaptive if:
Danish: Tal med lægen, før De tager Tredaptive, hvis:
English: Diet and other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with Tredaptive.
Danish: Diæt og anden ikke-farmakologisk behandling (f.eks. motion, vægtreduktion) bør fortsætte under behandlingen med Tredaptive.
English: Flushing is the most common adverse reaction of Tredaptive.
Danish: Flushing er den mest almindelige bivirkning ved Tredaptive.
English: Acetylsalicylic acid provides no additional reduction of flushing beyond that achieved by Tredaptive.
Danish: Acetylsalicylsyre giver ikke yderligere reduktion af flushing, ud over den der opnås ved Tredaptive.
English: Therefore, Tredaptive should not be used in children and adolescents under 18 years of age.
Danish: Derfor må Tredaptive ikke anvendes til børn og teenagere under 18 år.
English: INFORMATION IN BRAILLE Tredaptive
Danish: INFORMATION I BRAILLESKRIFT Tredaptive
English: • Your doctor should do a blood test before you start taking Tredaptive to check how well your liver is working.
Danish: • Lægen bør tage en blodprøve, før De begynder at tage Tredaptive for at kontrollere, hvor godt
English: • when you cannot control your cholesterol levels with a statin alone (class of cholesterol-lowering medicines working in the liver);
Danish: • når mængden af kolesterol ikke kan kontrolleres ved hjælp af et statin alene (en gruppe af kolesterolsænkende lægemidler, der virker i leveren).
English: • Your doctor may also want you to periodically have blood tests after you start taking Tredaptive, to check how well your liver is working and for other side effects.
Danish: • Lægen vil måske også tage blodprøver af og til, efter De er begyndt at tage Tredaptive for at kontrollere, hvor godt Deres lever virker, og om der er andre bivirkninger.
English: It is unknown whether there is an increased risk of myopathy in other Asian patients treated with Tredaptive co-administered with simvastatin or ezetimibe/simvastatin.
Danish: Det vides ikke, om der er en øget risiko for myopati hos andre asiatiske patienter, som behandles med Tredaptive samtidigt med simvastatin eller ezetimibe/simvastatin.
English: The effect on lipids was similar whether Tredaptive was given as monotherapy or was added to ongoing statin therapy with or without ezetimibe.
Danish: Indvirkningen på lipider var den samme, hvad enten Tredaptive blev givet som monoterapi eller blev tilføjet til den igangværende statinbehandling med eller uden ezetimibe.
English: In clinical trials, over 5,700 patients received Tredaptive alone or with an HMG-CoA reductase inhibitor.
Danish: I kliniske undersøgelser har mere end 5.700 patienter fået Tredaptive alene eller sammen med en HMG-CoA-reduktasehæmmer.
English: If Tredaptive is missed for less than 7 consecutive days, patients can resume therapy at the last administered dose.
Danish: Hvis patienten har undladt at tage Tredaptive i færre end 7 på hinanden følgende dage, kan behandlingen genoptages ved den senest administrerede dosis.
English: ▲ Tredaptive  nicotinic acid (laropiprant withdrawn at Week 21)
Danish: ▲ Tredaptive  nicotinsyre (laropiprant seponeret ved uge 21)
English: If you stop taking Tredaptive Do not stop taking Tredaptive without talking to your doctor.
Danish: De må ikke holde op med at tage Tredaptive uden at tale med lægen.
English: The incidence and frequency of moderate or greater flushing in patients treated with Tredaptive for the duration of the study decreased.
Danish: Incidensen og hyppigheden af moderat og mere udbredt flushing hos patienter, der fik Tredaptive i hele studiets varighed, faldt.
English: Figure 2 Percentage of Patients with Moderate or Greater Flushing Symptoms Across Weeks 1-32
Danish: Figur 2 Procentdel af patienter med moderate eller mere udbredte flushing-symptomer hen over ugerne 1-32
English: Not known: frequency cannot be estimated from the available data Additionally, the following were reported during post-marketing experience with Tredaptive and/or other nicotinic acid products (alone and/or with certain other cholesterol-lowering medicines):
Danish: Ikke kendt: hyppigheden kan ikke vurderes ud fra tilgængelige data Desuden er følgende bivirkninger blevet rapporteret efter markedsføring af Tredaptive og/eller andre nicotinsyrepræparater (alene og/eller sammen med visse andre kolesterolsænkende lægemidler):
English: If muscle pain, weakness or cramps occur while a patient is receiving Tredaptive with a statin, their CK levels should be measured.
Danish: Hvis muskelsmerter, -svaghed eller -kramper opstår, mens patienten er i behandling med Tredaptive sammen med et statin, skal CK-koncentrationerne måles.
English: Patients receiving Tredaptive concomitantly with acetylsalicylic acid and clopidogrel should be closely monitored as recommended in the Summary of Product Characteristics for those medicinal products and should be told that it might take longer than usual to stop bleeding and that they should report any unusual bleeding (site or duration) to their physician.
Danish: Patienter, der får Tredaptive sammen med acetylsalicylsyre og clopidogrel, bør monitoreres tæt, som anbefalet i produktresuméet for disse lægemidler, og skal informeres om, at det kan tage længere tid end normalt at stoppe en blødning, og at de skal indberette al unormal blødning (sted eller varighed) til lægen.
English: Physicians contemplating combined therapy with statins and Tredaptive should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs and symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and when the dose of either medicinal product is increased.
Danish: Læger, som overvejer kombinationsbehandling med statiner og Tredaptive, bør nøje overveje de mulige fordele i forhold til risikoen og bør monitorere patienterne nøje med henblik på tegn og symptomer på muskelsmerte, -ømhed eller -svaghed, især i de første måneder af behandlingen, og når doseringen af et af lægemidlerne øges.
English: When Tredaptive is co-administered with a statin, please refer to the Summary of Product Characteristics for that particular medicinal product.
Danish: Når Tredaptive gives samtidigt med et statin henvises til produktresuméet for dette specifikke lægemiddel.
English: In a pool of four active- or placebo-controlled clinical trials (N=4,747, n=2,548 taking Tredaptive), flushing was reported in 12.3 % of patients taking Tredaptive.
Danish: I fire aktive eller placebo-kontrollerede kliniske undersøgelser (N=4.747, n=2.548, der tog Tredaptive) blev der rapporteret om flushing hos 12,3 % af de patienter, der fik Tredaptive.
English: The Coronary Drug Project, a five year study completed in 1975, showed that nicotinic acid had a statistically significant benefit in decreasing nonfatal, recurrent myocardial infarctions (MI) in men 30 to 64 years old with a history of MI.
Danish: Coronary Drug Project, en fem-årig undersøgelse, der afsluttedes i 1975, viste, at nicotinsyre havde en statistisk signifikant positivindvirkning på reduktionen af nonfatale, tilbagevendende myokardieinfarkter (MI) hos mænd i alderen 30-64 år med MI i anamnesen.
English: If you forget to take Tredaptive
Danish: Hvis De har glemt at tage Tredaptive
English: However, if you do not take Tredaptive for 7 or more days in a row, talk to your doctor before restarting Tredaptive.
Danish: Men hvis De ikke har taget Tredaptive i 7 dage eller mere i træk, skal De tale med lægen, før De igen begynder at tage Tredaptive.
English: Tredaptive was consistently efficacious across all prespecified patient subpopulations defined by race, gender, baseline LDL-C, HDL-C and TG levels, age and diabetes status.
Danish: Tredaptive var konsekvent effektivt på tværs af alle på forhånd specificerede patientundergrupper i henhold til race, køn, LDL-C, HDL-C og TG ved baseline, alder og diabetesstatus.