FrancophonIA/ELRC3.0 huggingface dataset:
English: However, in February 2012, following the review of a study called ALTITUDE, the CHMP recommended that Rasilez should not be used together with an ACE inhibitor or ARB in patients with diabetes or with moderate or severe kidney impairment because of an increase in the risk of cardiovascular and kidney problems.
Danish: Efter gennemgang af undersøgelsen ALTITUDE anbefalede CHMP imidlertid i februar 2012, at Rasilez ikke bør anvendes sammen med en ACEhæmmer eller en ARB hos patienter med sukkersyge eller moderat til svær nyrefunktionsnedsættelse på grund af øget risiko for kardiovaskulære problemer eller nyresygdomme.
English: The most common side effects with Rasilez (seen in between 1 and 10 patients in 100) are dizziness, diarrhoea, arthralgia (joint pain) and hyperkalaemia (high blood potassium levels).
Danish: De hyppigste bivirkninger ved Rasilez (som optræder hos mellem 1 og 10 patienter ud af 100) er svimmelhed, diarré, artralgi (ledsmerter) og hyperkaliæmi (for højt kaliumindhold i blodet).
English: Why has Rasilez been approved?
Danish: Hvorfor blev Rasilez godkendt?
English: Combination studies looked at Rasilez used with an ACE inhibitor (ramipril), an ARB (valsartan), a beta-blocker (atenolol), a calcium-channel blocker (amlodipine) and a diuretic (hydrochlorothiazide).
Danish: I kombinationsundersøgelserne blev Rasilez anvendt sammen med en angiotensinkonvertaseenzymhæmmer (ramipril), en angiotensinreceptorantagonist (valsartan), en betablokker (atenolol), en calciumkanalblokker (amlodipin) og et vanddrivende middel (hydrochlorthiazid).
English: For the full list of all side effects reported with Rasilez, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Rasilez fremgår af indlægssedlen.
English: Rasilez may be taken alone or in combination with other medicines for hypertension, with the exception of ‘angiotensin converting enzyme (ACE) inhibitors' or ‘angiotensin receptor blockers' (ARBs) in patients with diabetes, or moderate or severe kidney impairment.
Danish: Rasilez kan anvendes alene eller sammen med andre lægemidler mod hypertension bortset fra “angiotensinkonvertasehæmmere” (ACEhæmmere) eller “angiotensinreceptorantagonister” (ARB) hos patienter med sukkersyge eller moderat til svært nedsat nyrefunktion.
English: Rasilez in combination with an ACE inhibitor or an ARB must not be used in patients with diabetes, or moderate or severe kidney impairment.
Danish: Rasilez kombineret med en ACE-hæmmer eller en ARB må ikke anvendes hos patienter med sukkersyge eller moderat til svær nyresygdom.
English: What benefit has Rasilez shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Rasilez?
English: How has Rasilez been studied?
Danish: Hvordan blev Rasilez undersøgt?
English: What is Rasilez used for?
Danish: Hvad anvendes Rasilez til?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rasilez have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Rasilez.
English: The studies with Rasilez taken in combination with other medicines showed additional decreases in blood pressure compared with the decreases produced by these medicines alone.
Danish: Undersøgelserne viste, at når Rasilez blev anvendt sammen med andre lægemidler, mindskedes blodtrykket mere, end når disse lægemidler anvendtes alene.
English: What is Rasilez?
Danish: Hvad er Rasilez?
English: Rasilez, taken alone or in combination with other medicines, was also compared with other medicines for hypertension.
Danish: Rasilez blev dels taget alene, dels i kombination med andre lægemidler og blev sammenlignet med andre lægemidler mod for højt blodtryk.
English: How is Rasilez used?
Danish: Hvordan anvendes Rasilez?
English: Larger falls were seen in patients aged 65 years or over and those taking higher doses of Rasilez.
Danish: Hos patienter over 65 år og patienter, der fik Rasilez i større doser, blev blodtrykket sænket yderligere.
English: How does Rasilez work?
Danish: Hvordan virker Rasilez?
English: More information can be found here.
Danish: Yderligere oplysninger kan findes her.
English: This overview was last updated in 11-2018.
Danish: Dette sammendrag blev sidst ajourført i 11-2018.
English: Each study lasted three to four months.
Danish: Hvert studie varede 3-4 måneder.
English: In the context of a procedure under Article 20 of Regulation (EC) No 726/2004.
Danish: I forlængelse af en indbringelsesprocedure i henhold til artikel 20 i forordning (EF) nr. 726/2004.
English: Heart failure
Danish: Hjertesvigt
English: Corlentor must not be taken with a number of other medicines.
Danish: Corlentor må ikke tages sammen med en række andre lægemidler.
English: Corlentor received a marketing authorisation valid throughout the EU on 25 October 2005.
Danish: Corlentor fik en markedsføringstilladelse med gyldighed i hele EU den 25. oktober 2005.
English: Corlentor (ivabradine)
Danish: Corlentor (ivabradin)
English: Further information on Corlentor can be found on the Agency's website: https://www.ema.europa.eu/en/medicines/human/EPAR/corlentor
Danish: Yderligere information om Corlentor findes på agenturets websted under: https://www.ema.europa.eu/en/medicines/human/EPAR/corlentor.
English: Other information about Corlentor
Danish: Andre oplysninger om Corlentor
English: In stable angina, these symptoms appear during physical effort.
Danish: Ved stabil angina viser disse symptomer sig under fysisk anstrengelse.
English: Corlentor therefore reduces or prevents the symptoms of angina.
Danish: Corlentor reducerer eller forbygger således symptomerne på angina.
English: The main measure of effectiveness was how long patients could exercise on a bicycle or a treadmill, which was measured at the start and the end of each study.
Danish: Virkningen blev hovedsageligt målt på, hvor længe patienterne kunne motionere på en cykel eller trædemølle, målt ved begyndelsen og slutningen af hvert studie.
English: As for all medicines, data on the use of Corlentor are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Corlentor løbende overvåget.
English: For more information about using Corlentor, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Corlentor, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: However it should be noted that patients in this study were given doses higher than the recommended dose (up to 10 mg twice a day).
Danish: Det skal dog bemærkes, at patienterne i dette studie fik højere doser end den anbefalede dosis (op til 10 mg to gange dagligt).
English: What measures are being taken to ensure the safe and effective use of Corlentor?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Corlentor?
English: Corlentor contains the active substance ivabradine.
Danish: Corlentor indeholder det aktive stof ivabradin.
English: The Agency decided that Corlentor's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet afgjorde, at fordelene ved Corlentor opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Bradycardia (slow heart rate) is common (it may affect up to 1 in 10 people).
Danish: Langsom hjerterytme (bradykardi) er almindelig (kan forekomme hos op til 1 ud af 10 personer).
English: Corlentor is available as tablets (5 and 7.5 mg) and it can only be obtained with a prescription.
Danish: Corlentor fås som tabletter (5 og 7,5 mg) og udleveres kun efter recept.
English: Results showed that the medicine was more effective than placebo in one of the studies in 360 patients.
Danish: Resultaterne viste, at lægemidlet var mere effektivt end placebo i et af studierne hos 360 patienter.
English: An overview of Corlentor and why it is authorised in the EU
Danish: Oversigt over Corlentor og hvorfor det er godkendt i EU
English: Side effects reported with Corlentor are carefully evaluated and any necessary action taken to protect patients.
Danish: Indberettede bivirkninger ved Corlentor vurderes omhyggeligt, og der træffes de nødvendige forholdsregler til at beskytte patienterne.
English: However, a fifth study in 728 patients showed that adding Corlentor to amlodipine did not provide an additional benefit.
Danish: Et femte studie hos 728 patienter viste imidlertid ingen ekstra fordel af at tilføje Corlentor til amlodipin.
English: In patients over 75 years old, a lower starting dose of 2.5 mg twice a day can be used.
Danish: Hos patienter over 75 år kan der anvendes en lavere startdosis på 2,5 mg to gange dagligt.
English: When used for angina, treatment should be stopped if symptoms do not improve after 3 months.
Danish: Når lægemidlet anvendes til behandling af angina, bør behandlingen stoppes, hvis symptomerne ikke bedres i løbet af 3 måneder.
English: Why is Corlentor authorised in the EU?
Danish: Hvorfor blev Corlentor godkendt i EU?
English: In a fourth study in 889 patients, Corlentor was more effective than placebo, when both were added to atenolol.
Danish: I et fjerde studie med 889 patienter var Corlentor mere effektivt end placebo, når de begge blev tilføjet til atenolol.
English: It must not be used in women who are pregnant, breast-feeding or by women who could become pregnant and who are not using appropriate contraceptives.
Danish: Det må ikke anvendes hos kvinder, der er gravide eller ammer, eller hos kvinder, der er i den fødedygtige alder og ikke anvender sikker prævention.
English: It was as effective as atenolol (a beta blocker) in a study of 939 patients and as effective as amlodipine (another medicine used to treat angina) in a study of 1,195 patients.
Danish: Det var lige så effektivt som atenolol (en betablokker) i et studie med 939 patienter, og lige så effektivt som amlodipin (et andet lægemiddel til behandling af angina) i et studie med 1.195 patienter.
English: What is Corlentor and what is it used for?
Danish: Hvad er Corlentor, og hvad anvendes det til?
English: The main measure of effectiveness was a reduction in the risk of death due to heart problems and non-fatal heart attack.
Danish: Virkningen blev hovedsageligt målt på mindsket risiko for hjertedød og ikke-dødeligt hjerteanfald.
English: The most common side effect with Corlentor ( which may affect more than 1 in 10 people) is luminous phenomena or ‘phosphenes' (a temporary brightness in the field of vision).
Danish: Den hyppigste bivirkning med Corlentor (som kan forekomme hos mere end 1 ud af 10 patienter), er forbigående lysfornemmelser eller "fosfener" (forbigående oplysthed i synsfeltet).
English: When these currents are blocked, the heart rate is lowered, so that the heart has less work to do and needs less oxygenated blood.
Danish: Når disse strømme blokeres, nedsættes hjertefrekvensen, så hjertet skal arbejde mindre og ikke behøver så meget iltet blod.
English: Treatment must be stopped if the heart rate is persistently below 50 beats per minute or if symptoms of bradycardia (slow heart rate) continue despite dose reduction.
Danish: Behandlingen skal standses, hvis hjertefrekvensen vedholdende er lavere end 50 slag pr. minut, eller hvis den langsomme hjertefrekvens (bradykardi) fortsætter trods dosisnedsættelse.
English: Results showed that Corlentor was more effective than placebo at preventing death due to disease of the heart or blood vessels or hospitalisation due to worsening heart failure: 24.5% (793 out of 3,241) of patients treated with Corlentor died or were hospitalised due to worsening heart failure, compared with 28.7% (937 out of 3,264) of patients receiving placebo.
Danish: Resultaterne viste, at Corlentor var mere effektivt end placebo til at forebygge dødsfald som følge af sygdom i hjerte eller blodkar, eller indlæggelse pga. forværret hjertesvigt: 24,5 % (793 ud af 3.241) af de patienter, der blev behandlet med Corlentor, døde eller blev indlagt som følge af forværret hjertesvigt, sammenholdt med 28,7 % (937 ud af 3.264) af dem, der blev behandlet med placebo.
English: What are the risks associated with Corlentor?
Danish: Hvilke risici er der forbundet med Corlentor?
English: The symptoms of heart failure are caused by the heart not pumping enough blood around the body.
Danish: Symptomerne ved hjertesvigt skyldes, at hjertet ikke pumper tilstrækkeligt blod rundt i kroppen.
English: For the treatment of angina, Corlentor was originally authorised for patients whose heart rate is at least 60 beats per minute.
Danish: Til behandling af angina blev Corlentor oprindeligt godkendt til patienter med en puls på mindst 60 slag pr. minut.
English: In this study, a specific subgroup of patients who had symptomatic angina had a small but significant increase in the combined risk of cardiovascular death or non-fatal heart attack with Corlentor compared with placebo (3.4% vs 2.9% yearly incidence rates).
Danish: I dette studie havde en særlig undergruppe af patienter med symptomgivende angina en lille, men statistisk sikker stigning i den kombinerede risiko for hjerte-kar-dødelighed og ikke-dødeligt hjerteanfald, når de fik Corlentor, i forhold til placebo (3,4 % mod 2,9 % i årlig forekomst).
English: By lowering the heart rate, Corlentor reduces the stress on the heart, thereby slowing the progression of heart failure and improving symptoms.
Danish: Ved at sænke pulsen nedsætter Corlentor belastningen af hjertet, bremser derved udviklingen af hjertesvigt og bevirker bedring af symptomerne.
English: A sixth study compared Corlentor with placebo in 19,102 patients with coronary artery disease and without clinical heart failure.
Danish: I et sjette studie sammenlignedes Corlentor med placebo hos 19.102 patienter med koronararteriesygdom og uden klinisk hjertesvigt.
English: Corlentor must not be used in patients who have a resting heart rate below 70 beats per minute, very low blood pressure, various types of heart disorder (including cardiogenic shock, rhythm disorders, heart attack, unstable or acute (sudden) heart failure and unstable angina) or severe liver problems.
Danish: Corlentor må ikke anvendes hos patienter med en hvilende hjertefrekvens på under 70 pr. minut, meget lavt blodtryk, forskellige hjertesygdomme (herunder kardiogent shock, rytmeforstyrrelser, hjerteanfald, ustabilt eller pludseligt (akut) hjertesvigt og ustabil angina) eller svære leverproblemer.
English: The active substance in Corlentor, ivabradine, works by blocking the ‘If currents' in the sinus node, the ‘pacemaker' for the heart that controls the heart's contractions and regulates the heart rate.
Danish: Det aktive stof i Corlentor, ivabradin, virker ved at blokere "If-strømmene" i sinusknuden - hjertets "pacemaker", som styrer hjertets sammentrækninger og regulerer hjertefrekvensen.
English: It also concluded that Corlentor was effective in long-term heart failure with an acceptable safety profile.
Danish: Udvalget konkluderede også, at Corlentor var effektivt til behandling af kronisk hjerteinsufficiens og havde en acceptabel sikkerhedsprofil.
English: Corlentor was compared with placebo (a dummy treatment) and other treatments in five main studies involving over 4,000 adults with long-term stable angina.
Danish: Corlentor er blevet sammenlignet med virkningsløs behandling (placebo) og andre behandlinger i fem hovedstudier hos over 4.000 voksne med langvarig stabil angina.
English: The European Medicines Agency concluded that Corlentor was shown to be effective in long-term angina with an acceptable safety profile for it to provide an alternative treatment for patients who cannot take beta blockers or whose disease is not controlled with them.
Danish: CHMP konkluderede, at Corlentor var påvist at være effektivt til behandling af kronisk angina og havde en acceptabel sikkerhedsprofil, som gjorde, at det kunne bruges som en alternativ behandling hos patienter, der ikke kan tage betablokkere, eller hvis sygdom ikke kan kontrolleres med disse.
English: It is used in combination with standard therapy including beta blockers, or in patients who cannot be treated with beta blockers.
Danish: Det anvendes i kombination med standardbehandling, herunder betablokkere, eller hos patienter, der ikke kan behandles med betablokkere.
English: The recommended starting dose is 5 mg twice a day with meals, which the doctor may increase to 7.5 mg twice a day or decrease to 2.5 mg (half a 5-mg tablet) twice a day depending on the patient's heart rate and symptoms.
Danish: Dette kan af lægen sættes op til 7,5 mg to gange dagligt eller sættes ned til 2,5 mg (en halv 5 mg tablet) to gange dagligt, afhængigt af patientens hjertefrekvens og symptomer.
English: Also, the doctor should consider stopping treatment if the medicine has only a limited effect on reducing angina symptoms or reducing the heart rate within 3 months.
Danish: Lægen bør desuden overveje at stoppe behandlingen, hvis lægemidlet efter 3 måneder kun har en begrænset virkning på symptomerne eller kun i begrænset omfang sænker hjertefrekvensen.
English: Corlentor is also used in patients with long-term heart failure (when the heart cannot pump enough blood to the rest of the body) who have a normal heart rhythm and whose heart rate is at least 75 beats per minute.
Danish: Corlentor anvendes desuden hos patienter, hos hvem hjertet til stadighed ikke kan pumpe tilstrækkeligt med blod til resten af kroppen (kronisk hjertesvigt), og som har normal hjerterytme og en puls på mindst 75 slag pr. minut.
English: Corlentor was compared with placebo in one main study involving over 6,500 patients with long-term moderate to severe heart failure.
Danish: Corlentor er desuden blevet sammenlignet med placebo i ét hovedstudie med over 6.500 patienter med langvarigt moderat til svært hjertesvigt.
English: How is Corlentor used?
Danish: Hvordan anvendes Corlentor?
English: However, the use was later restricted to patients whose heart rate is at least 70 beats per minute.1
Danish: Anvendelsen blev dog senere begrænset til patienter med en puls på mindst 70 slag pr. minut1.
English: What benefits of Corlentor have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Corlentor?
English: It is used in those who cannot be treated with beta blockers (another type of medicine to treat angina) or in combination with a beta blocker in patients whose disease is not controlled by beta blockers alone.
Danish: Det anvendes hos patienter, der ikke kan behandles med en anden type medicin mod angina (betablokkere) eller i kombination med betablokkere hos patienter, hos hvem sygdommen ikke kan kontrolleres med betablokkere alene.
English: Corlentor is a heart medicine used to treat the symptoms of long-term stable angina (pains to the chest, jaw and back, brought on by physical effort) in adults with coronary artery disease (disease of the heart caused by the obstruction of the blood vessels that supply blood to the heart muscle).
Danish: Corlentor er et lægemiddel, der anvendes mod symptomer i form af langvarige stabile smerter i brystet, kæben og ryggen (angina), som opstår ved fysisk anstrengelse hos voksne med hjertesygdom som følge af forsnævring af blodkarrene til hjertemusklen (koronararteriesygdom).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Corlentor have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Corlentor.
English: For the full list of restrictions with Corlentor, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger med Corlentor fremgår af indlægssedlen.
English: For the full list of all side effects reported with Corlentor, see the package leaflet.
Danish: Den fuldstændige liste over alle indberettede bivirkninger ved Corlentor fremgår af indlægssedlen.
English: How does Corlentor work?
Danish: Hvordan virker Corlentor?
English: The symptoms of angina are caused by the heart not receiving enough oxygenated blood.
Danish: Anginasymptomerne skyldes, at hjertet ikke får tilstrækkeligt med iltet blod.
English: The medicine is used in patients who have a normal heart rhythm, and whose heart rate is at least 70 beats per minute.
Danish: Lægemidlet anvendes hos patienter med normal hjerterytme og en puls på mindst 70.
English: 25 May 2012
Danish: Den 25. maj 2012
English: International non-proprietary name (inn): doramectin
Danish: Internationalt fællesnavn (INN): doramectin
English: Veterinary Medicines and Product Data Management
Danish: Veterinærlægemidler og styring af produktdata
English: Written explanations were provided by the applicant on 13 September 2011 and 11 January 2012.
Danish: Ansøgeren fremsendte skriftlige redegørelser den 13. september 2011 og den 11. januar 2012.
English: The final opinion was converted into a Decision by the European Commission on 25 May 2012.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 25. maj
English: Doramectin is a macrocyclic lactone and is closely related to ivermectin.
Danish: Doramectin er en makrocyklisk lacton, der er nært beslægtet med ivermectin.
English: The application was submitted to Ireland as reference Member State and Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Greece, Spain, Finland, France, Hungary, Latvia, Lithuania, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Sweden as concerned Member States, as well as Iceland and Norway.
Danish: Ansøgningen blev indgivet i Irland, som var referencemedlemsstat, og de berørte medlemsstater var Østrig, Bulgarien, Cypern, Tjekkiet, Danmark, Estland, Grækenland, Spanien, Finland, Frankrig, Ungarn, Letland, Litauen, Malta, Nederlandene, Polen, Portugal, Rumænien, Slovakiet, Slovenien og Sverige samt Island og Norge.
English: The decentralised procedure started on 26 February 2010.
Danish: Den decentrale procedure blev indledt den 26. februar 2010.
English: The Committee appointed Dr Michael Holzhauser-Alberti as rapporteur and Dr David Murphy as co-rapporteur.
Danish: Som rapportør og co-rapportør udpegede udvalget henholdsvis dr. Michael Holzhauser-Alberti og dr. David Murph.
English: Article 33(4) of Directive 2001/82/EC, as amended
Danish: Artikel 33, stk. 4, i direktiv 2001/82/EF, som ændret.
English: The applicant, Pfizer Limited, submitted an application for a decentralised procedure for the above mentioned veterinary medicinal product in the framework of Article 32 of Directive 2001/82/EC, as amended.
Danish: Ansøgeren, Pfizer Limited, indgav en ansøgning efter den decentrale procedure for ovennævnte veterinærlægemiddel i henhold til artikel 32 i direktiv 2001/82/EØF, som ændret.
English: Potential serious risks were identified during the decentralised procedure by two concerned Member States regarding the environmental risk assessment (the Netherlands and France) and regarding the proposed withdrawal period for cattle (the Netherlands).
Danish: Under den decentrale procedure påpegede to berørte medlemsstater potentielle alvorlige risici vedrørende miljørisikovurderingen (Nederlandene og Frankrig) og vedrørende den foreslåede tilbageholdelsestid for kvæg (Nederlandene).
English: Both compounds share a wide spectrum of antiparasitic activity and produce a similar paralysis in nematodes and parasitic arthropods.
Danish: De to stoffer har begge et bredt antiparasitært spektrum og frembringer samme form for paralyse hos nematoder og parasitære arthropoder.
English: The referral procedure started on 5 May 2011.
Danish: Henvisningsproceduren blev indledt den 5. maj 2011.
English: Opinion following an Article 33(4)
Danish: Udtalelse efter en indbringelse i henhold til artikel 33, stk.