FrancophonIA/ELRC3.0 huggingface dataset:
English: If, during treatment, heart rate decreases below 50 beats per minute (bpm) at rest or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, the dose must be titrated downward including the lowest dose of 2.5 mg twice daily (one half 5 mg tablet twice daily).
Danish: Hvis hjertefrekvensen i hvile permanent falder til under 50 slag/min, eller hvis patienten får symptomer på bradykardi som fx svimmelhed, træthed, eller hypotension, skal dosis nedsættes, herunder den laveste dosis på 2,5 mg to gange dagligt (en halv 5 mg tablet to gange dagligt).
English: Therefore, ivabradine is contra-indicated during breast-feeding (see section 4.3).
Danish: Ivabradin er derfor kontraindiceret under amning (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Corlentor 7.5 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Corlentor 7,5 mg filmovertrukne tabletter
English: Make sure to tell your doctor if you are taking any of the following medicines, as a dose adjustment of Corlentor or monitoring should be required: - fluconazole (an antifungal medicine) - rifampicin (an antibiotic) - barbiturates (for difficult sleeping or epilepsy) - phenytoin (for epilepsy) - Hypericum perforatum or St John's Wort (herbal treatment for depression) - QT prolonging medicines to treat either heart rhythm disorders or other conditions : - quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders) - bepridil (to treat angina pectoris) - certain types of medicines to treat anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindole) - anti-malarial medicines (such as mefloquine or halofantrine) - intravenous erythromycin (an antibiotic) - pentamidine (an antiparasitic medicine) - cisapride (against the gastro-oesophageal reflux) - Some types of diuretics which may cause decrease in blood potassium level, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema, high blood pressure).
Danish: Hypericum perforatum eller perikon (naturmedicin for depression) medicin, der forlænger QT-intervallet i ekg til behandling af enten hjerterytmeforstyrrelser eller andre sygdomme, som f.eks.: - quinidin, disopyramid, ibutilid, sotalol, amiodaron (til behandling af forstyrrelser af hjertets rytme) - bepridil (til behandling af angina pectoris) - visse lægemidler til behandling af angst, skizofreni eller andre alvorlige sindslidelser (fx pimozid, ziprasidon og sertindol) - malariamidler (fx mefloquin eller halofantrin) - intravenøs erythromycin (et antibiotikum) - pentamidin (et lægemiddel mod parasitter) - cisaprid (mod mavesyre-reflux fra mavesæk til spiserør) nogle typer vanddrivende medicin (diuretika), der kan medføre nedsat kaliumniveau i blodet, såsom furosemid, hydrochlorthiazid, indapamid (anvendt til at behandle ødemer og højt blodtryk)
English: Other secondary endpoints: - All cause death - Death from HF - Hospitalisation for any cause - Hospitalisation for CV reason
Danish: Primære sammensatte endepunkt Komponenterne i det sammensatte endepunkt: - Kardiovaskulær død - Indlæggelse pga. tiltagende hjerteinsufficiens Sekundære endepunkter: - Død uanset årsag - Død pga. hjerteinsufficiens - Indlæggelse uanset årsag - Indlæggelse pga. kardiovaskulær sygdom
English: Salmon-coloured, oblong, film-coated tablet scored on both sides, engraved with “5” on one face and on the other face.
Danish: Laksefarvet, aflang, filmovertrukken tablet med delekærv på begge sider, mærket med ”5” på den ene side og på den anden.
English: MON TUE WED THU FRI SAT SUN
Danish: MAN TIR ONS TOR FRE LØR SØN
English: NAME OF THE MEDICINAL PRODUCT Corlentor 5 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Corlentor 5 mg filmovertrukne tabletter
English: It is recommended that the decision to initiate or titrate treatment takes place with the availability of serial heart rate measurements, ECG or ambulatory 24-hour monitoring.
Danish: Symptomatisk behandling af kronisk stabil angina pectoris Det anbefales, at beslutningen om at initiere eller titrere behandlingen foregår med mulighed for seriemåling af hjertefrekvens, ekg- eller ambulant 24-timers monitorering.
English: Corlentor 5 mg: one film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride).
Danish: Corlentor 5 mg: En filmovertrukket tablet indeholder 5 mg ivabradin (hvilket svarer til 5,390 mg ivabradin som hydrochlorid).
English: NAME OF THE MEDICINAL PRODUCT Corlentor 5 mg film-coated tablets ivabradine
Danish: LÆGEMIDLETS NAVN Corlentor 5 mg filmovertrukne tabletter ivabradin
English: Salmon-coloured, triangular, film-coated tablet engraved with “7.5” on one face and on the other face.
Danish: Laksefarvet, trekantet, filmovertrukken tablet, mærket med ”7.5” på den ene side og på den anden.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/317/001-007
Danish: EU/1/05/317/001-007
English: QT prolonging medicinal products - Cardiovascular QT prolonging medicinal products (e.g. quinidine, disopyramide, bepridil, sotalol,
Danish: Lægemidler, der forlænger QT-intervallet - Kardiovaskulære QT-forlængende lægemidler (fx quinidin, disopyramid, bepridil, sotalol, ibutilid eller amiodaron) - Non-kardiovaskulære QT-forlængende lægemidler (fx pimozid, ziprasidon, sertindol, mefloquin,
English: NAME OF THE MEDICINAL PRODUCT Corlentor 7.5 mg film-coated tablets ivabradine
Danish: LÆGEMIDLETS NAVN Corlentor 7,5 mg filmovertrukne tabletter ivabradin
English: One film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride).
Danish: En filmovertrukken tablet indeholder 5 mg ivabradin (ækvivalent med 5,390 mg ivabradin som hydrochlorid).
English: Corlentor 7.5 mg: one film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride).
Danish: Corlentor 7,5 mg: En filmovertrukket tablet indeholder 7,5 mg ivabradin (hvilket svarer til 8,085 mg ivabradin som hydrochlorid).
English: Excipient with known effect: 63.91 mg lactose monohydrate For the full list of excipients, see section 6.1.
Danish: Hjælpestof, som behandleren skal være opmærksom på: 63,91 mg lactosemonohydrat.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One film-coated tablet contains 5 mg ivabradine (equivalent to 5.39 mg ivabradine as hydrochloride)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En filmovertrukket tablet indeholder 5 mg ivabradin (svarende til 5,39 mg ivabradin som hydrochlorid)
English: Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist (see section 4.4).
Danish: Behandlingen skal seponeres, hvis hjertefrekvensen forbliver under 50 slag i minuttet, eller hvis der er vedholdende symptomer på grund af bradykardi (se pkt.
English: Ivabradine is indicated : - in adults unable to tolerate or with a contra-indication to the use of beta-blockers - or in combination with beta-blockers in patients inadequately controlled with an optimal beta blocker dose.
Danish: Ivabradin er indiceret: til voksne, som ikke tåler betablokkere, eller for hvem betablokkere er kontraindiceret.
English: Malaise, possibly related to bradycardia
Danish: Svimmelhed, eventuelt i forbindelse med bradykardi
English: About chronic heart failure :
Danish: Kronisk hjertesvigt:
English: What Corlentor is and what it is used for What you need to know before you take Corlentor How to take Corlentor
Danish: Det skal De vide, før De begynder at tage Corlentor Sådan skal De tage Corlentor Bivirkninger
English: Asthenia, possibly related to bradycardia Fatigue, possibly related to bradycardia
Danish: Ikke almindelig* Asteni, kan være forbundet med bradykardi Træthed, kan være forbundet med bradykardi
English: Heart failure must be stable before considering ivabradine treatment.
Danish: Før behandling med ivabradin overvejes, skal patientens hjerteinsufficiens være stabil.
English: Dyspnoea
Danish: Diarré
English: One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride).
Danish: En filmovertrukken tablet indeholder 7,5 mg ivabradin (ækvivalent med 8,085 mg ivabradin som hydrochlorid).
English: The main efficacy criterion was the composite of cardiovascular death, hospitalization for acute MI or hospitalization for new onset or worsening heart failure.
Danish: Det væsentligste effektmål var sammensat af kardiovaskulær død, indlæggelse pga.
English: Pharmacokinetic/pharmacodynamic (PK/PD) relationship
Danish: Farmakokinetiske/farmakodynamiske forhold
English: B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Danish: BILAG II A. FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: In a post-hoc subgroup of patients with symptomatic angina at randomisation (n=1507), no safety signal was identified regarding cardiovascular death, hospitalization for acute MI or heart failure (ivabradine 12.0% versus placebo 15.5%, p=0.05).
Danish: AMI eller hjertesvigt (ivabradin 12,0 % versus placebo 15,5 %; p=0,05).
English: Drug-drug interaction studies have established that CYP3A4 inhibitors increase ivabradine plasma concentrations, while inducers decrease them.
Danish: Hæmmere og induktorer af CYP3A4 er tilbøjelige til at interagere med ivabradin og påvirke dets metabolisme og farmakokinetik i klinisk signifikant grad. Lægemiddelinteraktionsstudier har vist, at CYP3A4-hæmmere øger plasmakoncentrationen af ivabradin, mens induktorer nedsætter den.
English: josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone (see sections 4.5 and 5.2) - Combination with verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate reducing properties (see section 4.5) - Pregnancy, lactation and women of child-bearing potential not using appropriate contraceptive measures (see section 4.6)
Danish: 4.5 og 5.2) - Samtidig behandling med verapamil eller diltiazem, som er moderate CYPP3A4-hæmmere med hjertefrekvenssænkende egenskaber (se pkt.
English: Syncope, possibly related to bradycardia
Danish: Ikke almindelig* Synkope, kan være forbundet med bradykardi
English: Skin and subcutaneous tissue Uncommon*
Danish: Ikke almindelig* Angioødem Udslæt
English: A therapeutic scheme higher than the approved posology was used (starting dose 7.5 mg b.i.d.
Danish: Der blev anvendt et terapeutisk skema med højere doser end de godkendte (startdosis 7,5 mg to gange dagligt (5 mg to gange dagligt hvis alderen er ≥75 år) og titreret op til 10 mg to gange dagligt).
English: - if your resting heart rate before treatment is too slow (below 70 beats per minute); - if you are suffering from cardiogenic shock (a heart condition treated in hospital); - if you suffer from a heart rhythm disorder; - if you are having a heart attack; - if you suffer from very low blood pressure; - if you suffer from unstable angina (a severe form in which chest pain occurs very frequently and with or without exertion); - if you have heart failure which has recently become worse; - if your heart beat is exclusively imposed by your pacemaker; - if you suffer from severe liver problems; - if you are already taking medicines for the treatment of fungal infections (such as ketoconazole,
Danish: Tag ikke Corlentor hvis De er allergisk over for ivabradin eller et af de øvrige indholdsstoffer i Corlentor (angivet i punkt 6) hvis Deres hjertefrekvens i hvile før behandlingen er for langsom (under 70 slag i minuttet) hvis De lider af kardiogent shock (en hjertesygdom, som skal behandles på hospital) hvis De lider af forstyrrelser i hjertets rytme hvis De får et hjerteanfald hvis De lider af meget lavt blodtryk hvis De lider af ustabil hjertekrampe (en alvorlig form med hyppige brystsmerter, der opstår både under hvile og anstrengelse) hvis De lider af hjertesvigt, og Deres tilstand for nylig er forværret hvis Deres hjerterytme udelukkende styres af en pacemaker hvis De lider af svære leverproblemer hvis De allerede tager medicin til behandling af svampeinfektioner (fx ketoconazol, itraconazol), makrolidantibiotika (fx josamycin, clarithromycin, telithromycin eller erythromycin givet oralt) eller medicin til behandling af hiv-infektioner (som fx nelfinavir, ritonavir) eller nefazodon (medicin til behandling af depressioner) eller diltiazem, verapamil (bruges til for højt blodtryk eller angina pectoris) hvis De er en kvinde i den fødedygtige alder og ikke anvender sikker prævention; - hvis De er gravid eller forsøger at blive gravid; hvis De ammer.
English: - This medicine has been prescribed for you.
Danish: Lægemidlet er receptpligtigt.
English: Excipients
Danish: Dosering
English: One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En filmovertrukket tablet indeholder 7,5 mg ivabradin (svarende til 8,085 mg ivabradin som hydrochlorid)
English: Stroke
Danish: Synet
English: What is in this leaflet:
Danish: Corlentor indeholder:
English: This summary was last updated in 11-2011.
Danish: Dette sammendrag blev sidst ajourført i 11-2011.
English: Axura should be given once a day, at the same time every day.
Danish: Axura skal gives en gang dagligt på samme tidspunkt hver dag.
English: It should not be poured or pumped directly into the mouth.
Danish: Den må ikke hældes eller pumpes direkte ind i munden.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Axura on 17 May 2002.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Axura den 17. maj 2002.
English: The full EPAR for Axura can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Axura findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is available as tablets (5 mg, 10 mg, 15 mg and 20 mg).
Danish: Det fås som tabletter ((5 mg, 10 mg, 15 mg og 20 mg).
English: This is a summary of the European public assessment report (EPAR) for Axura.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Axura.
English: If the solution is used, the dose should first be pumped onto a spoon or into a glass of water.
Danish: Hvis opløsningen anvendes, skal den først pumpes ud på en ske eller ned i et glas vand.
English: In addition, overstimulation of the NMDA receptors can result in cell damage or death.
Danish: Desuden kan overstimulering af NMDA-receptorerne medføre cellebeskadigelse eller -død.
English: Neurotransmitters are chemicals in the nervous system that allow nerve cells to communicate with one another.
Danish: Neurotransmittere er kemiske stoffer i nervesystemet, der gør det muligt for nerveceller at meddele sig til hinanden.
English: Other information about Axura
Danish: Andre oplysninger om Axura
English: To prevent side effects, the dose of Axura is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day.
Danish: For at undgå bivirkninger øges dosis af Axura gradvist i løbet af de tre første uger af behandlingen: I den første uge er dosis 5 mg, i den anden uge er den 10 mg, og i den tredje uge er den 15 mg. Fra uge fire og fremover er den anbefalede vedligeholdelsesdosis 20 mg én gang dagligt.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Axura.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Axura.
English: Axura was compared with placebo (a dummy treatment) over 24 to 28 weeks.
Danish: Axura blev sammenlignet med placebo (en virkningsløs behandling) i en periode på 24 til 28 uger.
English: Alzheimer's disease is a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour.
Danish: Alzheimers sygdom er en type demens (en hjernesygdom), der gradvis påvirker hukommelse, intellektuelle evner og adfærd.
English: For more information about treatment with Axura, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Axura, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Treatment should be started and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease.
Danish: Behandling bør kun indledes og skal overvåges af en læge med erfaring i diagnosticering og behandling af Alzheimers sygdom.
English: The CHMP decided that Axura's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Axura opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Axura was more effective than placebo at controlling the symptoms of Alzheimer's disease.
Danish: Axura var mere effektivt end placebo til at begrænse symptomerne på Alzheimers sygdom.
English: However, when these results were considered along with those of the three additional studies, it was noted that the effect of Axura was smaller in patients with mild disease.
Danish: Men når disse resultater blev sammenholdt med resultaterne af de tre supplerende undersøgelser, fremgik det, at virkningen af Axura var mindre hos patienter med lettere sygdom.
English: The first study involved 252 patients with moderately severe to severe disease, while the other two involved a total of 873 patients with mild to moderate disease.
Danish: Den første undersøgelse omfattede 252 patienter med moderat svær til svær sygdom, mens de to andre undersøgelser omfattede tilsammen 873 patienter med let til moderat sygdom.
English: Axura is used to treat patients with moderate to severe Alzheimer's disease.
Danish: Axura anvendes til behandling af patienter med moderat til svær Alzheimers sygdom.
English: The most common side effects with Axura (seen in between 1 and 10 patients in 100) are somnolence (sleepiness), dizziness, hypertension (high blood pressure), dyspnoea (difficulty breathing), constipation, headache and drug hypersensitivity (allergy to the medicine).
Danish: De hyppigste bivirkninger ved Axura (som optræder hos mellem 1 og 10 patienter ud af 100) er somnolens (søvnighed), svimmelhed, for højt blodtryk, dyspnø (vejrtrækningsbesvær), forstoppelse og hovedpine og lægemiddeloverfølsomhed (allergi over for lægemidlet).
English: Axura has been studied in three main studies including a total of 1,125 patients with Alzheimer's disease, some of whom had taken other medicines for their disease in the past.
Danish: Axura blev anvendt i tre hovedundersøgelser med i alt 1 125 patienter med Alzheimers sygdom, hvoraf nogle tidligere havde fået andre lægemidler mod sygdommen.
English: The main measures of effectiveness were the change in symptoms in three main areas: functional (the degree of disability), cognitive (the ability to think, learn and remember) and global (a combination of several areas including general function, cognitive symptoms, behaviour and the ability to carry out everyday activities).
Danish: Virkningen blev hovedsagelig bedømt på ændringen i symptomerne på tre hovedområder: funktionelle evner (invaliditetsgrad), kognitive evner (tænke-, indlærings- og huskeevne) og overordnede funktioner (en kombination af generel funktionsevne, kognitive symptomer, adfærd og evnen til at udføre daglige aktiviteter).
English: Axura is also available as an oral solution, which is supplied with a pump that delivers 5 mg memantine hydrochloride with each activation.
Danish: Axura fås også som en oral opløsning, der fås med en pumpe, som afgiver 5 mg memantinhydrochlorid ved hver aktivering.
English: Memantine works by blocking special types of receptor called NMDA receptors, to which the neurotransmitter glutamate normally attaches.
Danish: Memantin virker ved at blokere en bestemt type receptorer kaldet NMDA-receptorer, som signalstoffet glutamat normalt binder sig til.
English: EPAR summary for the public memantine hydrochloride
Danish: EPAR - sammendrag for offentligheden memantinhydrochlorid
English: Treatment should only be started if a caregiver is available who will regularly monitor the use of Axura by the patient.
Danish: Behandling bør kun iværksættes, hvis patienten har en omsorgsgiver, der regelmæssigt overvåger patientens indtagelse af Axura.
English: The active substance in Axura, memantine hydrochloride, is an antidementia medicine.
Danish: Det aktive stof i Axura, memantinhydrochlorid, er et middel mod demens.
English: Axura must not be used in people who are hypersensitive (allergic) to memantine hydrochloride or any of the other ingredients.
Danish: Axura må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for memantinhydrochlorid eller andre af indholdsstofferne.
English: Axura was also studied in three additional studies including a total of 1,186 patients with mild to severe disease.
Danish: Axura blev desuden anvendt i tre supplerende undersøgelser med tilsammen 1 186 patienter med let til svær sygdom.
English: Axura is a medicine that contains the active substance memantine hydrochloride.
Danish: Axura er et lægemiddel, der indeholder det aktive stof memantinhydrochlorid.
English: In the study of moderately severe to severe disease, patients taking Axura had fewer symptoms than those taking placebo after 28 weeks, as measured on both global and functional scores.
Danish: I undersøgelsen af patienter med moderat svær til svær sygdom resulterede Axura efter 28 uger i færre symptomer end placebo, målt både på samlet score og funktionsscore.
English: Why has Axura been approved?
Danish: Hvorfor blev Axura godkendt?
English: For the full list of all side effects reported with Axura, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Axura fremgår af indlægssedlen.
English: What is the risk associated with Axura?
Danish: Hvilken risiko er der forbundet med Axura?
English: The tolerance and dose should be assessed within 3 months after starting treatment, and from then on the benefits of continuing treatment with Axura should be reassessed on a regular basis.
Danish: måneder efter behandlingens start, og herefter bør fordelene ved at fortsætte behandlingen med Axura regelmæssigt genvurderes.
English: What is Axura?
Danish: Hvad er Axura?
English: In the two studies of mild to moderate disease, patients on Axura had less severe symptoms after 24 weeks, as measured on the global and cognitive scores.
Danish: I de to undersøgelser af let til moderat sygdom havde de patienter, der fik Axura, efter 24 uger færre alvorlige symptomer.
English: What is Axura used for?
Danish: Hvad anvendes Axura til?
English: How has Axura been studied?
Danish: Hvordan blev Axura undersøgt?
English: What benefit has Axura shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Axura?
English: How is Axura used?
Danish: Hvordan anvendes Axura?
English: How does Axura work?
Danish: Hvordan virker Axura?
English: This summary was last updated in 04-2015.
Danish: Dette sammendrag blev sidst ajourført 04-2015.
English: It is used to treat:
Danish: Det anvendes til behandling af:
English: The dose depends on the disease being treated, the age and condition of the patient, and the response to treatment, but it should not exceed 800 mg a day.
Danish: Dosis afhænger af den behandlede sygdom, patientens alder og tilstand samt reaktionen på behandlingen, men den bør ikke overstige 800 mg dagligt.