FrancophonIA/ELRC3.0 huggingface dataset:
English: Dexamfetamine is not indicated in all children with ADHD and the decision to use dexamfetamine must be based on a very thorough assessment of the severity and chronicity of the child's symptoms in relation to the child's age and potential for abuse, misuse or diversion.
Danish: Dexamfetamin er ikke indiceret til alle børn med ADHD, og beslutningen om at anvende dexamfetamin skal baseres på en meget grundig vurdering af, hvor svære og kroniske barnets symptomer er i forhold til barnets alder, samt muligheden for misbrug, forkert brug eller videresalg.
English: Abuse, misuse, and diversion
Danish: Misbrug, forkert brug og videresalg
English: [The wording below should be deleted]
Danish: [Ordlyden nedenfor skal slettes]
English: [The following wording should be added at the end of this section] Reporting of suspected adverse reactions
Danish: [Den følgende ordlyd skal tilføjes i slutningen af dette punkt] Indberetning af formodede bivirkninger
English: [The below wording should be inserted at the top of the document]
Danish: [Følgende ordlyd skal indsættes øverst i dokumentet]
English: Amendments to the summary of product characteristics and package leaflet
Danish: Ændringer til produktresuméet og indlægssedlen
English: [The following wording should be added at the end of this section]
Danish: [Følgende ordlyd skal tilføjes i slutningen af dette punkt]
English: Dexamed is used to treat attention-deficit/hyperactivity disorder (ADHD).
Danish: Anvendelse [Disse punkter skal have følgende ordlyd] {Dexamed} anvendes til at behandle ADHD (attention deficit and hyperactivity disorder).
English: • it is not indicated in all children with ADHD.
Danish: • Det er ikke alle børn med ADHD, der skal have {Dexamed og relaterede navne}.
English: [The following sentence should be added in its place] The risk is generally greater for short acting stimulants than for corresponding long-acting products (see section 4.1).
Danish: Risikoen er generelt større for stimulanter med kort virkningsvarighed end for tilsvarende præparater med lang virkningsvarighed (se pkt.
English: Note: These amendments are to be incorporated to the valid Summary of Product Characteristics, labelling and package leaflet which are the final versions achieved during the Coordination group procedure
Danish: Bemærk: Disse ændringer skal indføres i det gældende produktresumé, etikettering og indlægsseddel.
English: (Invented) name Strength Pharmaceutical Form
Danish: (Særnavn) Navn
English: This summary was last updated in 09-2007.
Danish: Dette sammendrag blev sidst ajourført i 09-2007
English: The marketing authorisation was renewed on 21 March 2007.
Danish: Markedsføringstilladelsen blev fornyet den 21. marts 2007.
English: The dose may be adjusted, depending on body weight.
Danish: Dosis kan tilpasses afhængigt af kropsvægten.
English: The marketing authorisation holder is Glaxo Group Ltd.
Danish: Indehaveren af markedsføringstilladelsen er Glaxo Group Ltd.
English: Treatment should be started as soon as possible after diagnosis and continued for up to eight days or until the patient is discharged from hospital.
Danish: Behandlingen bør indledes hurtigst muligt, efter at diagnosen er stillet og bør fortsætte i op til otte dage, eller indtil patienten udskrives fra hospitalet.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Quixidar on 21 March 2002.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Quixidar den 21. marts 2002.
English: For patients having surgery, the first dose should be given six hours after the end of the operation.
Danish: Til operationspatienter skal den første dosis gives 6 timer efter afslutning af operationen.
English: Other information about Quixidar:
Danish: Andre oplysninger om Quixidar:
English: In all studies, the main measure of effectiveness was the overall rate of thrombotic events (problems caused by blood clots).
Danish: I alle undersøgelserne var hovedmålet for effekt den samlede hyppighed af trombotiske komplikationer (problemer forårsaget af blodpropper).
English: The full EPAR for Quixidar can be found here.
Danish: Den fuldstændige EPAR for Quixidar findes her.
English: However, these results were insufficient to show whether Quixidar was more effective than unfractionated heparin or not.
Danish: Disse resultater var dog ikke tilstrækkelige til at vise, hvorvidt Quixidar var mere effektiv end ufraktioneret heparin.
English: As with other antithrombotic medicines, the most common side effect of Quixidar is bleeding.
Danish: Som for andre antitrombotiske lægemidler er den hyppigste bivirkning af Quixidar blødning.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) QUIXIDAR EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) QUIXIDAR EPAR - sammendrag for offentligheden
English: The main measure of effectiveness was the proportion of patients who died or had an ‘ischaemic event' (restriction of blood supply to an organ, including the heart).
Danish: Hovedmålestokken for effekt var andelen af patienter, som døde eller var ude for en ‘iskæmisk hændelse' (begrænsning af blodforsyningen til et organ, herunder hjertet).
English: Blood clotting can be a problem when blood flow is disturbed in any way.
Danish: Blodpropper kan være et problem, når blodets strømning forstyrres.
English: The Committee recommended that Quixidar be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af en markedsføringstilladelse for Quixidar.
English: When this is blocked, no thrombin (another factor) can be produced, and no clot can be formed.
Danish: Når dette stof blokeres, kan der ikke dannes trombin (en anden faktor), og derfor størkner blodet ikke.
English: Quixidar is not recommended in patients who are about to undergo certain types of PCI.
Danish: Quixidar anbefales ikke til patienter, som står over for at skulle gennemgå visse former for PCI.
English: By reducing blood clots, Quixidar can also help the flow of blood to the heart to be maintained in patients with angina or who are having a heart attack.
Danish: Ved at reducere blodpropperne kan Quixidar også medvirke til at opretholde blodtilførslen til hjertet hos patienter med angina, eller som får et hjerteanfald.
English: For patients who have kidney problems, Quixidar may not be suitable, or the lower 1.5-mg dose may be used.
Danish: Quixidar er muligvis ikke egnet til patienter med nyreproblemer, eller den lavere dosis på 1,5 mg kan anvendes.
English: In the study of myocardial infarction with ST segment elevation, Quixidar reduced the risk of death or another heart attack by 14% after 30 days, compared to standard care.
Danish: I undersøgelsen af myokardieinfarkt med ST-segmentforhøjelse reducerede Quixidar risikoen for død eller endnu et hjerteanfald med 14 % efter 30 dage i sammenligning med en standardbehandling.
English: Quixidar is an anticoagulant; it prevents the blood from coagulating (clotting).
Danish: Quixidar er et antikoagulerende middel: det forhindrer blodet i at koagulere (størkne).
English: Quixidar contains the active substance fondaparinux sodium (1.5, 2.5, 5, 7.5 or 10 mg per syringe).
Danish: Quixidar indeholder det aktive stof fondaparinuxnatrium (1,5, 2,5, 5, 7,5 eller 10 mg pr. injektionssprøjte).
English: It can also be used in patients at high risk (because of their age or disease) when they have abdominal surgery, especially for cancer, or when they are forced to stay in bed because of an acute illness.
Danish: Det kan desuden anvendes til patienter, der på grund af deres alder eller sygdommens art er i højrisikogruppen i forbindelse med abdominal kirurgi, navnlig for kræft, eller er sengeliggende på grund af akut sygdom.
English: ‘percutaneous coronary intervention' (PCI) is an operation to unblock the heart's blood vessels,
Danish: ‘perkutan koronar intervention' (PCI) er en operation, som foretages for at udvide hjertets blodårer,
English: Quixidar has also been studied in two main studies of patients with unstable angina or myocardial infarction.
Danish: Quixidar blev også undersøgt i to hovedundersøgelser af patienter med ustabil angina eller myokardieinfarkt.
English: It was also compared with placebo (a dummy treatment) when looking at patients with an acute illness (839 patients) and patients treated for an additional 24 days following hip fracture surgery (656 patients).
Danish: Det blev også sammenlignet med placebo (virkningsløs behandling) hos patienter med akut sygdom (839 patienter) og patienter, der blev behandlet i yderligere 24 dage efter operation for hoftebensbrud (656 patienter).
English: Quixidar was at least as effective as enoxaparin in preventing death or an ischaemic event in patients with unstable angina or myocardial infarction without ST segment elevation, with around 5% of the patients in each group had died or had an ischaemic event after nine days.
Danish: Quixidar var mindst lige så effektiv som enoxaparin til at forebygge død eller iskæmisk hændelse, selv hos patienter med ustabil angina eller myokardieinfarkt uden ST-segmentforhøjelse, idet ca. 5 % af patienterne i hver gruppe var døde eller havde haft en iskæmisk hændelse efter ni dage.
English: What is the risk associated with Quixidar?
Danish: Hvilken risiko er der forbundet med Quixidar?
English: Treatment should be continued until the risk of VTE has been reduced, usually at least five to nine days after surgery.
Danish: Behandlingen skal fortsætte, indtil risikoen for blodpropper i venerne er aftaget, sædvanligvis mindst fem til ni dage.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Quixidar's benefits are greater than its risks in both the prevention and the treatment of VTEs, unstable angina and myocardial infarction.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at de gavnlige virkninger af Quixidar er større end risiciene til forebyggelse og behandling af venøs tromboemboli, ustabil angina og myokardieinfarkt.
English: The 2.5 mg strength is also used to treat patients with unstable angina (a type of chest pain that changes in severity) or who are having a myocardial infarction (heart attack):
Danish: 2,5 mg-styrken anvendes også til at behandle patienter med ustabil angina (en form for brystsmerter af skiftende sværhedsgrad), eller som har et myokardieinfarkt (hjerteanfald):
English: Why has Quixidar been approved?
Danish: Hvorfor blev Quixidar godkendt?
English: For the full list of restrictions, see the Package Leaflet.
Danish: Den fuldstændige liste over begrænsningerne i anvendelsen fremgår af indlægssedlen.
English: For patients with unstable angina or myocardial infarction, the recommended dose is 2.5 mg once daily by subcutaneous injection, but the first dose is given intravenously (into a vein) through an existing line or as an infusion (drip) in patients with ST segment elevation.
Danish: For patienter med ustabil angina eller myokardieinfarkt er den anbefalede dosis 2,5 mg en gang daglig ved subkutan injektion, men den første dosis gives intravenøst (i en vene) via en eksisterende ledning eller som en infusion (drop) hos patienter med ST-segmentforhøjelse.
English: By using Quixidar after surgery, the risk of a blood clot forming is greatly reduced.
Danish: Brug af Quixidar efter operationen begrænser risikoen for blodpropdannelse væsentligt.
English: The active ingredient in Quixidar, fondaparinux sodium, stops one of the substances (factors) that are involved in the clotting of blood, Factor Xa.
Danish: Det aktive stof i Quixidar, fondaparinuxnatrium, blokerer et af de stoffer, faktor Xa, der medvirker ved blodets størkning.
English: For the full list of all side effects reported with Quixidar, see the Package Leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Quixidar fremgår af indlægssedlen.
English: In the prevention of VTEs, the recommended dose of Quixidar is 2.5 mg once a day by subcutaneous injection (under the skin).
Danish: Til forebyggelse af VTE er den anbefalede dosis af Quixidar 2,5 mg én gang dagligt, indgivet ved subkutan injektion (indsprøjtning under huden).
English: Quixidar is a solution for injection in a prefilled syringe.
Danish: Quixidar er en opløsning til injektion i en fyldt injektionssprøjte.
English: In the prevention studies, Quixidar was compared with other anticoagulants: enoxaparin (in hip or knee surgery; over 8,000 patients) or dalteparin (in abdominal surgery; 2,927 patients).
Danish: I undersøgelserne af forebyggelsen blev Quixidar sammenlignet med andre antikoagulanter: enoxaparin (ved hofte- og knæoperationer, over 8 000 patienter) eller dalteparin (ved abdominal kirurgi, 2 927 patienter).
English: For more information, see the Summary of Product Characteristics (also part of the EPAR).
Danish: De nærmere oplysninger fremgår af produktresuméet (også en del af EPAR).
English: The first compared the effects of Quixidar with those of enoxaparin in over 20,000 patients with unstable angina or myocardial infarction without ST segment elevation, and the second compared Quixidar with standard care (unfractionated heparin in eligible patients, or placebo) in over 12,000 patients with myocardial infarction with ST segment elevation.
Danish: I den første sammenlignedes effekten af Quixidar med effekten af enoxaparin hos over 20 000 patienter med ustabil angina eller myokardieinfarkt uden ST-segmentforhøjelse, og i den anden sammenlignedes Quixidar med en standardbehandling (ufraktioneret heparin hos egnede patienter eller placebo) hos over 12 000 patienter med myokardieinfarkt med ST-segmentforhøjelse.
English: The overall rate of thrombotic events in patients treated with Quixidar was significantly less than in patients treated with placebo or enoxaparin (for patients undergoing leg surgery), and was similar to that seen with enoxaparin (treatment of DVT), dalteparin or unfractionated heparin.
Danish: Totalhyppigheden af trombotiske komplikationer hos patienter behandlet med Quixidar var betydeligt lavere end hos patienter behandlet med placebo eller enoxaparin (for patienter opereret i benene) og svarede til enoxaparin (ved behandling af blodpropper i de dybe vener), dalteparin eller ufraktioneret heparin.
English: At higher strengths (5, 7.5 and 10 mg), Quixidar is used to treat VTEs such as deep vein thrombosis (DVT, a blood clot in the leg) or pulmonary embolism (PE, blood clot in the lung).
Danish: Quixidar anvendes ved højere styrker (5, 7,5 og 10 mg) til at behandle venøs tromboemboli (VTE) såsom dyb venetrombose (DVT, en blodprop i benet) eller lungeemboli (PE, en blodprop i lungen).
English: How has Quixidar been studied?
Danish: Hvordan blev Quixidar undersøgt?
English: In the treatment of VTE, Quixidar was compared with enoxaparin (DVT: 2,192 patients) or with unfractionated heparin (PE: 2,184 patients).
Danish: Til behandling af venøs tromboemboli blev Quixidar sammenlignet med enoxaparin (blodpropper i de dybe vener, 2 192 patienter) eller med ufraktioneret heparin (blodpropper i lungerne, 2 184 patienter).
English: What benefit has Quixidar shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Quixidar?
English: In the treatment of DVT or PE, the recommended dose is 7.5 mg once a day by subcutaneous injection, usually for seven days.
Danish: Til behandling af blodpropper i de dybe vener eller lungeemboli er den anbefalede dosis af Quixidar 7,5 mg én gang dagligt, normalt i syv dage.
English: What is Quixidar used for?
Danish: Hvad anvendes Quixidar til?
English: How is Quixidar used?
Danish: Hvordan anvendes Quixidar?
English: What is Quixidar?
Danish: Hvad er Quixidar?
English: The effectiveness of Quixidar has been studied for the prevention of and in the treatment of VTE.
Danish: Quixidars virkning er blevet undersøgt dels til forebyggelse, dels til behandling af venøs tromboemboli.
English: Quixidar should not be used in people who may be hypersensitive (allergic) to fondaparinux sodium or any of the other ingredients, who might be bleeding already, who have acute bacterial endocarditis (an infection of the heart) or have severe kidney problems.
Danish: Quixidar bør ikke anvendes til patienter, som kan være overfølsomme (allergiske) over for fondaparinuxnatrium eller andre af indholdsstofferne, til patienter, som i forvejen bløder, til patienter,
English: • without ‘ST segment elevation' (an abnormal reading on the electrocardiogram or ECG) in patients who are not going to undergo urgent angioplasty (within two hours): angioplasty or
Danish: • uden ‘ST-segmentforhøjelse' (en abnorm måling på elektrokardiogrammet (ECG)) hos patienter,
English: • with ‘ST segment elevation' in patients who are receiving thrombolytic medicines (‘clot busters')
Danish: • med ‘ST-segmentforhøjelse' hos patienter, som får thrombolytica (‘opløser blodpropper'), eller som ikke står over for nogen anden behandling med sigte på at genoprette blodforsyningen til hjertet.
English: Quixidar (1.5 and 2.5 mg strengths) is used to prevent venous thromboembolic events (VTEs, problems caused by blood clots) in patients who are having major surgery to their legs, such as a hip replacement or surgery to repair a knee or hip fracture.
Danish: dannelse af blodpropper i venerne) hos patienter, der får foretaget større operationer i benene, f.eks. indsættelse af en hofteprotese, knæoperationer eller operationer for hoftebensbrud.
English: See also information under the heading “Do not take Imprida”.
Danish: Se også information under overskriften ”Tag ikke Imprida”.
English: Date of first authorisation: 17 January 2007 Date of latest renewal: 17 January 2012
Danish: Dato for første markedsføringstilladelse: 16. januar 2007 Dato for seneste fornyelse: 16. januar 2012
English: It is recommended to take Imprida with some water.
Danish: Det anbefales at tage Imprida med lidt vand.
English: In two long-term follow-up studies the effect of Imprida was maintained for over one year.
Danish: I to langtids-og opfølgningsstudier blev effekten af Imprida opretholdt i over et år.
English: Component of a multipack, not to be sold separately.
Danish: Del af multipakning, må ikke sælges separat.
English: Imprida with food and drink
Danish: Imprida sammen med mad og drikke
English: You can take Imprida with or without food.
Danish: - Du kan tage Imprida med eller uden mad.
English: Over 1,400 hypertensive patients received Imprida once daily in two placebo-controlled trials.
Danish: Mere end 1.400 hypertensive patienter har fået Imprida en gang daglig i to placebokontrollerede studier.
English: Imprida is not recommended in early pregnancy (first 3 months), and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Danish: Imprida frarådes i den tidlige periode af graviditeten (de første 3 måneder), og må ikke tages, hvis du er mere end 3 måneder henne i graviditeten, fordi det kan forårsage alvorlig skade på din baby, hvis det tages efter tredje måned af graviditeten.
English: If you have taken too many tablets of Imprida, or if someone else has taken your tablets, consult a doctor immediately.
Danish: Hvis du har taget for mange Imprida-tabletter, eller hvis andre har taget dine tabletter, skal du kontakte en læge med det samme.
English: Imprida and older people (age 65 years or over) Your doctor should exercise caution when increasing your dose.
Danish: Imprida og ældre patienter (65 år og derover) Din læge bør udvise forsigtighed, når dosis øges.
English: Children and adolescents The use of Imprida in children and adolescents is not recommended (aged below 18 years old).
Danish: Børn og teenagere Brug af Imprida til børn og teenagere frarådes (under 18 år).
English: Correction of this condition prior to administration of Imprida or close medical supervision at the start of treatment is recommended.
Danish: Det anbefales, at denne tilstand korrigeres før administration af Imprida, eller at der foretages tæt medicinsk overvågning ved behandlingens start.
English: Do not use any Imprida pack that is damaged or shows signs of tampering.
Danish: Brug ikke pakninger med Imprida, som er beskadiget eller viser tegn på åbning.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR) Indehaveren af markedsføringstilladelsen skal fremsende periodiske, opdaterede sikkerhedsindberetninger (PSUR) for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: Age, gender, race or body mass index (≥30 kg/m 2, <30 kg/m 2) did not influence the response to
Danish: Alder, køn, race eller body mass indeks (≥30 kg/m 2, <30 kg/m 2) havde ingen indflydelse på Impridas virkning.
English: The usual dose of Imprida is one tablet per day.
Danish: Den sædvanlige dosis af Imprida er én tablet daglig.
English: If a diurectic is also used, the risk of lithium toxicity may presumably be increased further with Imprida.
Danish: Hvis der samtidig gives et diuretikum, kan risikoen for lithiumtoksicitet muligvis være yderligere øget med Imprida.
English: If you get these symptoms, stop taking Imprida and contact your doctor straight away.
Danish: Hvis du får disse symptomer, skal du stoppe med at tage Imprida og kontakte din læge med det samme.
English: Imprida should be discontinued immediately in patients who develop angioedema and should not be re-administered.
Danish: Imprida skal seponeres straks hos patienter, som udvikler angioødem, og behandlingen bør ikke genoptages.
English: There is no experience of overdose with Imprida.
Danish: Der er ingen erfaring med overdosering af Imprida.
English: Imprida has not been studied in any patient population other than hypertension.
Danish: Imprida er ikke undersøgt i andre patientgrupper end hypertension.
English: The safety of Imprida has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine.
Danish: Impridas sikkerhed er blevet evalueret i fem kontrollerede kliniske studier med 5.175 patienter, hvoraf 2.613 modtog valsartan i kombination med amlodipin.
English: if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body).
Danish: - hvis du har forsnævring af aorta svarende til aortaklappen (aortastenose) eller kardiogent shock (en tilstand, hvor hjertet ikke er i stand til at opretholde tilstrækkelig blodforsyning til kroppen).
English: Your doctor will normally advise you to stop taking Imprida before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Imprida.
Danish: Normalt vil din læge råde dig til at stoppe med at tage Imprida, inden du bliver gravid, eller så snart du har konstateret, at du er gravid.
English: To date there is no experience of the safe use of Imprida in patients who have had a recent kidney transplantation.
Danish: På nuværende tidspunkt er der ingen erfaring med sikkerheden ved brug af Imprida til patienter, som kort tid forinden har modtaget nyretransplantation.
English: If you think you may be allergic, talk to your doctor before taking Imprida.
Danish: Hvis du tror, du er allergisk, skal du tale med din læge, inden du tager Imprida.
English: Interactions common to the combination No drug-drug interaction studies have been performed with Imprida and other medicinal products.
Danish: Almindelige interaktioner med kombinationen Der er ikke udført lægemiddelinteraktionsstudier med Imprida og andre lægemidler.
English: Abrupt withdrawal of Imprida has not been associated with a rapid increase in blood pressure.
Danish: Pludselig seponering af Imprida er ikke blevet forbundet med hurtig blodtryksstigning.