FrancophonIA/ELRC3.0 huggingface dataset:
English: • Healthcare professionals have been informed in writing of these new recommendations, and the product information for Corlentor/Procoralan has been updated accordingly.
Danish: • Der er udsendt skriftlig information til sundhedspersoner om disse nye anbefalinger, og produktinformationen for Corlentor/Procoralan er ajourført tilsvarende.
English: Information to healthcare professionals
Danish: Information til sundhedspersoner
English: Corlentor and Procoralan are identical medicines that contain the active substance ivabradine.
Danish: Corlentor og Procoralan er identiske lægemidler, der indeholder det aktive stof ivabradin.
English: Because of a small but significant increase of the combined risk of cardiovascular death, myocardial infarction and heart failure seen in patients with symptomatic angina in the SIGNIFY study, recommendations have been issued to reduce this risk.
Danish: På grund af en lille, men signifikant forøgelse af den kombinerede risiko for kardiovaskulær død, myokardieinfarkt og hjerteinsufficiens hos patienter med symptomatisk angina i SIGNIFYundersøgelsen er der fremsat anbefalinger til mindskelse af denne risiko.
English: The PRAC recommendations have been endorsed by the Agency's Committee for Medicinal Products for Human Use (CHMP).
Danish: PRAC's anbefalinger er godkendt af agenturets Udvalg for Lægemidler til Mennesker (CHMP).
English: The CHMP opinion was sent to the European Commission, which issued a legally binding decision valid throughout the EU on 15 January 2015.
Danish: CHMP's anbefaling blev overgivet til Europa-Kommissionen, som traf en retligt bindende beslutning med gyldighed i hele EU den 15. januar 2015.
English: In addition, discontinuation should be considered if the improvement is only limited and if there is no clinically relevant reduction in resting heart rate within 3 months.
Danish: Seponering bør desuden overvejes, hvis bedringen er begrænset, og der efter tre måneder ikke er klinisk relevant reduktion i hvilende hjertefrekvens.
English: • Prior to starting treatment or when considering titration, serial heart rate measurements, ECG, or ambulatory 24-hour monitoring should be considered when determining the heart rate.
Danish: • Før påbegyndelse af behandlingen, og når dosistitrering påtænkes, bør det overvejes at foretage seriemålinger af hjertefrekvens, EKG eller ambulant 24-timers overvågning ved bestemmelse af hjertefrekvensen.
English: Its use is only beneficial for symptomatic treatment in patients with chronic stable angina pectoris who cannot be treated with beta-blockers, or in combination with beta-blockers in case their disease is not controlled with them alone.
Danish: Dets anvendelse er kun til fordel ved symptomatisk behandling af patienter med kronisk stabil angina pectoris, der ikke kan behandles med betablokkere, eller kombineret med betablokkere, når sygdommen ikke kan kontrolleres med disse alene.
English: On 20 November 2014, the European Medicines Agency (EMA) completed a review of Corlentor/Procoralan (ivabradine) and made recommendations aimed at reducing the risk of heart problems, including heart attack and bradycardia (excessively low heart rate), in patients taking the medicine for angina.
Danish: Den 20. november 2014 afsluttede Det Europæiske Lægemiddelagentur (EMA) en gennemgang af Corlentor/Procoralan (ivabradin) og fremsatte anbefalinger med henblik på at mindske risikoen for hjerteproblemer, herunder hjertetilfælde og for lav puls (bradykardi) hos patienter, der tager lægemidlet for angina.
English: The review was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Danish: Gennemgangen blev først foretaget af Udvalget For Risikovurdering inden for Lægemiddelvurdering (PRAC), som har ansvar for vurdering af sikkerhedsspørgsmål vedrørende lægemidler til mennesker, og som fremsatte et sæt anbefalinger.
English: However, the Agency reiterated that the starting dose for angina should not exceed 5 mg twice a day and that the maximum dose should not exceed 7.5 mg twice a day.
Danish: Agenturet gentog imidlertid, at startdosis ved angina ikke bør være over 5 mg to gange dagligt, og at den maksimale dosis ikke bør være over 7,5 mg to gange dagligt.
English: If, despite dose reduction, the heart rate remains below 50 bpm or symptoms of bradycardia persist, treatment must be discontinued.
Danish: Hvis hjertefrekvensen trods dosisreduktion forbliver under 50, eller symptomerne på bradykardi vedvarer, bør behandlingen seponeres.
English: • The benefit-risk balance of Corlentor/Procoralan remains positive for its authorised indications.
Danish: • Benefit/risk-forholdet for Corlentor/Procoralan er fortsat positivt til de godkendte indikationer.
English: The PRAC recommendations were then sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's final opinion.
Danish: Anbefalingerne fra PRAC blev overgivet til Udvalget for Lægemidler til Mennesker (CHMP), som har ansvar for alle spørgsmål vedrørende lægemidler til mennesker, og som vedtog agenturets endelige udtalelse.
English: • If during treatment the heart rate decreases below 50 bpm at rest or the patient experiences symptoms related to bradycardia, the dose must be decreased (the lowest dose is 2.5 mg twice daily).
Danish: • Hvis hjertefrekvensen under behandlingen kommer under 50, eller patienten får bradykardirelaterede symptomer, skal dosis nedsættes (laveste dosis er 2,5 mg to gange dagligt).
English: • The concomitant use of Corlentor/Procoralan with verapamil or diltiazem is now contraindicated.
Danish: • Anvendelse af Corlentor/Procoralan sideløbende med verapamil eller diltiazem er nu kontraindiceret.
English: The data also indicated a higher risk of bradycardia with Corlentor/Procoralan compared with placebo (17.9% vs.
Danish: Dataene viste desuden højere risiko for bradykardi med Corlentor/Procoralan end med placebo (17,9 % mod 2,1 %).
English: Corlentor/Procoralan is available as tablets.
Danish: Corlentor/Procoralan fås som tabletter.
English: The CHMP opinion was sent to the European Commission, which issued an EU-wide legally binding decision on 15 January 2015.
Danish: Den endelige udtalelse blev overgivet til Europa-Kommissionen, som vedtog en retligt bindende afgørelse den 15. januar 2015.
English: In its evaluation the EMA also assessed additional data on the safety and effectiveness of Corlentor/Procoralan which showed that the risk of atrial fibrillation is increased in patients treated with Corlentor/Procoralan compared with controls (4.9% vs 4.1%).
Danish: I sin vurdering gennemgik EMA desuden supplerende data om sikkerheden og effektiviteten af Corlentor/Procoralan, der viste højere risiko for atrieflimren hos patienter i behandling med Corlentor/Procoralan end hos kontrolpersoner (4,9 % mod 4,1 %).
English: Other recommendations are that doctors must not prescribe Corlentor/Procoralan together with the medicines verapamil or diltiazem that reduce the heart rate, and that they should monitor their patients for atrial fibrillation (irregular rapid contractions of the upper chambers of the heart).
Danish: Andre anbefalinger er, at lægen ikke må udskrive Corlentor/Procoralan sammen med lægemidlerne verapamil eller diltiazem, der nedsætter pulsen, og at lægen bør overvåge patienten for atrieflimren (uregelmæssige hurtige sammentrækninger af hjertets forkamre).
English: If atrial fibrillation develops during treatment, the balance of benefits and risks of continued Corlentor/Procoralan treatment should be carefully reconsidered.
Danish: Hvis der opstår atrieflimren under behandlingen, bør fordele og risici ved fortsat behandling med Corlentor/Procoralan nøje afvejes.
English: • The risk of developing atrial fibrillation is increased in patients treated with Corlentor/Procoralan.
Danish: • Risikoen for atrieflimren øges ved behandling med Corlentor/Procoralan.
English: • The data from SIGNIFY did not demonstrate a beneficial effect for Corlentor/Procoralan on cardiovascular outcomes in coronary artery patients without clinical heart failure.
Danish: • SIGNIFY viste ingen gavnlig virkning af Corlentor/Procoralan på det kardiovaskulære udfald hos patienter med koronararteriesygdom uden klinisk hjerteinsufficiens.
English: • Your doctor will start treatment with Corlentor/Procoralan at a dose of up to 5 mg twice daily and increase it if necessary to a maximum of 7.5 mg twice daily.
Danish: • Lægen vil påbegynde behandlingen med Corlentor/Procoralan med en dosis på op til 5 mg to gange dagligt og om nødvendigt sætte den op til at højst 7,5 mg to gange dagligt.
English: • The starting dose of Corlentor/Procoralan should not exceed 5 mg twice daily and the maintenance dose of Corlentor/Procoralan should not exceed 7.5 mg twice daily.
Danish: • Startdosis af Corlentor/Procoralan bør ikke være over 5 mg to gange dagligt, og vedligeholdelsesdosis af Corlentor/Procoralan bør ikke være over 7,5 mg to gange dagligt.
English: It works by lowering the heart rate thereby reducing the stress on the heart and slowing the progression of heart failure and reducing or preventing the symptoms of angina.
Danish: Dette forsinker udviklingen af hjertesvigt, og symptomerne på angina mindskes eller undgås.
English: • Corlentor/Procoralan must not be used together with the medicines verapamil or diltiazem which reduce the heart rate.
Danish: • Corlentor/Procoralan må ikke bruges sammen med lægemidlerne verapamil eller diltiazem, som nedsætter pulsen.
English: The review of Corlentor/Procoralan was first carried out by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC).
Danish: Gennemgangen af ivabradin blev først foretaget af EMA's Udvalg for Risikovurdering inden for Lægemiddelvurdering (PRAC).
English: Corlentor/Procoralan is also used in patients with long-term heart failure (when the heart cannot pump enough blood to the rest of the body).
Danish: Corlentor/Procoralan anvendes desuden ved langvarigt hjertesvigt, dvs. når hjertet ikke kan pumpe tilstrækkeligt med blod til resten af kroppen.
English: • Your doctor will stop treatment with Corlentor/Procoralan if your symptoms of angina (such as shortness of breath) do not improve within 3 months or if the improvement is only limited.
Danish: • Lægen vil standse behandlingen med Corlentor/Procoralan, hvis der i løbet af tre måneder ikke er bedring i dine anginasymptomer (såsom kortåndethed), eller bedringen kun er begrænset.
English: These recommendations are based on the EMA's review of the final data from the SIGNIFY study1, which showed that in a subgroup of patients who had symptomatic angina there was a small but significant increase in the combined risk of cardiovascular death or non-fatal heart attack with Corlentor/Procoralan compared with placebo (3.4% vs 2.9% yearly incidence rates).
Danish: Disse anbefalinger bygger på EMA's gennemgang af de endelige data fra SIGNIFY-undersøgelsen1 Undersøgelsen viste, at den samlede risiko for kardiovaskulær død eller ikkedødeligt hjertetilfælde hos en undergruppe af patienter med symptomatisk angina var større med Corlentor/Procoralan end med placebo.
English: • In the symptomatic treatment of patients with chronic stable angina, Corlentor/Procoralan should only be started if the patient's resting heart rate is above or equal to 70 beats per minute (bpm).
Danish: • Symptomatisk behandling af kronisk stabil angina med Corlentor/Procoralan bør kun indledes, hvis patientens hvilende hjertefrekvens er mindst 70.
English: • Corlentor/Procoralan should be discontinued if the symptoms of angina do not improve within 3 months.
Danish: • Corlentor/Procoralan bør seponeres ved manglende bedring i anginasymptomer efter tre måneder.
English: Corlentor/Procoralan is used to treat symptoms of long-term stable angina (chest pain due to problems with the blood flow to the heart) in adults with coronary heart disease (disease of the heart caused by the obstruction of the blood vessels that supply blood to the heart muscle) who have a normal heart rhythm.
Danish: Corlentor/Procoralan anvendes mod symptomerne på kronisk stabil angina (brystsmerter som følge af problemer med hjertets blodforsyning) hos voksne, der har hjertesygdom som følge af forsnævring af blodkarrene til hjertemusklen (koronararteriesygdom), og har normal hjerterytme.
English: When used for angina, Corlentor/Procoralan should only be started if the patient's resting heart rate is at least 70 beats per minute (bpm).
Danish: Når Corlentor/Procoralan anvendes mod angina, bør behandlingen kun påbegyndes, hvis patientens hvilepuls er mindst 70.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom was observed in 5.3% of patients taking Corlentor/Procoralan compared with 3.8% in the placebo group.
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: • Corlentor/Procoralan is a medicine used to treat symptoms of angina (chest pain due to problems with the blood flow to the heart) and to treat heart failure.
Danish: • Corlentor/Procoralan er et lægemiddel til behandling af angina (brystsmerter som følge af problemer med hjertets blodforsyning) og til behandling af hjertesvigt.
English: Patients in the SIGNIFY study were started on a higher than recommended dose of Corlentor/Procoralan and received up to 10 mg twice a day, which is higher than the currently authorised maximum daily dose (7.5 mg twice a day).
Danish: Patienterne i SIGNIFY-undersøgelsen fik i begyndelsen højere dosis af Corlentor/Procoralan end den anbefalede og op til 10 mg to gange dagligt.
English: Corlentor/Procoralan is used to treat symptoms of angina (chest pain due to problems with the blood flow to the heart) and to treat heart failure.
Danish: Corlentor/Procoralan anvendes til behandling af angina (smerter i brystet som følge af problemer med hjertets blodforsyning) og til behandling af hjertesvigt.
English: Because Corlentor/Procoralan has not been shown to provide benefits such as reducing the risk of heart attack or cardiovascular death (death due to heart problems), the medicine should only be used to alleviate symptoms of angina.
Danish: Det er ikke påvist, at Corlentor/Procoralan giver fordele såsom mindsket risiko for hjertetilfælde eller kardiovaskulær dødelighed (død som følge af hjerteproblemer).
English: • Your doctor will only start Corlentor/Procoralan if your resting heart rate is at least 70 beats per minute (bpm).
Danish: • Lægen vil kun sætte dig i behandling med Corlentor/Procoralan, hvis din hvilepuls er på mindst 70.
English: Doctors should consider stopping treatment if there is no improvement in angina symptoms after 3 months, or if the improvement is only limited.
Danish: Hvis der efter tre måneder ikke er bedring eller kun begrænset bedring i anginasymptomerne, bør lægen overveje at standse behandlingen.
English: Because patients treated with Corlentor/Procoralan for angina symptoms may be at increased risk of heart problems such as heart attack, recommendations have been issued to reduce this risk and ensure that the benefits continue to outweigh the risks.
Danish: Behandling af anginasymptomer med Corlentor/Procoralan kan øge risikoen for hjerteproblemer, såsom hjertetilfælde.
English: • Wash your hands thoroughly.
Danish: • Vask hænderne grundigt.
English: The absolute bioavailability is 76%.
Danish: Den absolutte biotilgængelighed er 76 %.
English: ----------------Study 2--------------- -------------Study 3------------- -------------Study 4------------Placebo
Danish: -------------------------Studie 2------------- ------------Studie 3--------- ------------Studie 4--------
English: Some of these patients have been under 50 years of age.
Danish: Nogle af disse patienter har været under 50 år.
English: Sepsis or risk of sepsis.
Danish: Sepsis eller risiko for sepsis.
English: Clear or almost clear defined as 0 or 1 on a 0 to 5 scale.
Danish: Klar eller næsten klar defineret som 0 eller 1 på en skala fra 0 til 5.
English: Wash your hands with soap and warm water.
Danish: Vask dine hænder med sæbe og varmt vand.
English: This is normal.)
Danish: Dette er normalt).
English: LIFMIOR can be taken with or without food or drink.
Danish: LIFMIOR kan anvendes med eller uden mad og drikke.
English: The 2 year data did not reveal any new safety findings.
Danish: Data for de 2 år afslørede ingen nye sikkerhedsresultater.
English: Serious allergic reactions are rare.
Danish: Alvorlige allergiske reaktioner er sjældne.
English: Mean duration was approximately 3 to 5 days.
Danish: Den gennemsnitlige varighed var ca. 3 til 5 dage.
English: Immediate use is then recommended.
Danish: Herefter anbefales umiddelbar brug.
English: The half-life is long, approximately 70 hours.
Danish: Dets halveringstid er lang, ca. 70 timer.
English: Key results of studies 2, 3 and 4 are shown below.
Danish: De vigtigste resultater fra studie 2, 3 og 4 er vist nedenfor.
English: Approximately half the cases were lymphomas.
Danish: Cirka halvdelen af disse tilfælde var lymfomer.
English: Check the expiry date (month/year) on the pen.
Danish: Kontroller udløbsdatoen (måned/år) på pennen.
English: If needed, you may cover the injection site with a bandage.
Danish: Hvis det er nødvendigt, kan du dække injektionsstedet med en bandage.
English: On pressing the centre of the button, you will hear a click.
Danish: Når du trykker midt på knappen, vil du høre et klik.
English: This is due to air pressure and should not be of concern.
Danish: Dette skyldes lufttryk og betyder ikke noget.
English: See section 4.4 for vaccination advice.
Danish: 4.4 om råd om vaccination.
English: (Note: After you have completed these steps, a small amount of liquid may remain in the vial.
Danish: (Bemærk: Når du er færdig med disse trin, kan der stadig være en lille smule væske i hætteglasset.
English: Do not be concerned, as you will remove the air in a later step.
Danish: Det betyder ikke noget, da luften vil blive fjernet på et senere tidspunkt.
English: *see Description of selected adverse reactions, below.
Danish: * se Beskrivelse af udvalgte bivirkninger, nedenfor.
English: Undesirable effects in adults
Danish: Uønskede virkninger hos voksne
English: These antibodies have all been non-neutralising and are generally transient.
Danish: Disse antistoffer har alle været ikke-neutraliserende og generelt forbigående.
English: LIFMIOR should only be used during pregnancy if clearly needed.
Danish: LIFMIOR bør kun anvendes under graviditet, hvis det er absolut nødvendigt.
English: This benefit was maintained in Year 2 of this study.
Danish: Denne bedring vedligeholdtes i år 2 af studiet.
English: If the doctor has not given this instruction, please contact him/her.
Danish: Hvis lægen ikke har givet dig denne instruktion, skal du kontakte ham/hende.
English: Paediatric population See Summary of the safety profile, above.
Danish: Pædiatrisk population Se ovenstående sammendrag af sikkerhedsprofilen.
English: b: Values for Disease Activity Score (DAS) are means.
Danish: b: Værdier for sygdoms aktivitets score (Disease Activity Score, DAS) er middelværdier.
English: They should not be used after the month and year shown.
Danish: Du må ikke bruges efter den angivne måned og år.
English: Hold the pen at a right angle (90º) to the injection site.
Danish: • Hold pennen i en ret vinkel (90º) mod injektionsstedet.
English: Do not warm LIFMIOR in any other way (for example, do not warm it in a microwave or in hot water).
Danish: LIFMIOR må ikke opvarmes på nogen anden måde (må for eksempel ikke opvarmes i mikrobølgeovn eller i varmt vand).
English: Do not warm in any other way.
Danish: Må ikke opvarmes på nogen anden måde.
English: Long-term studies to assess the safety of the combination are ongoing.
Danish: Der er langtidsstudier i gang til vurdering af sikkerheden ved kombinationsbehandlingen.
English: From a microbiological point of view, the reconstituted medicinal product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt bør det rekonstituerede lægemiddel anvendes umiddelbart.
English: D-88397 Biberach an der Riss
Danish: D-88397 Biberach an der Riss Tyskland
English: These are rare or uncommon side effects, but are serious conditions (some of which may rarely be fatal).
Danish: Dette er sjældne eller usædvanlige bivirkninger, men det er alvorlige tilstande (hvoraf nogle i sjældne tilfælde kan være dødelige).
English: Administration of live vaccines to infants for 16 weeks after the mother's last dose of LIFMIOR is generally not recommended.
Danish: Administration af levende vacciner til spædbørn inden for 16 uger efter moderens sidste LIFMIOR-dosis anbefales generelt ikke.
English: Consequently, the choice of intermittent or continuous therapy should be based upon physician judgment and individual patient needs.
Danish: Valget af intermitterende eller kontinuerlig behandling skal derfor baseres på lægens bedømmelse og den enkelte patients behov.
English: Wait until all the powder dissolves (usually less than 10 minutes).
Danish: Vent indtil alt pulveret er opløst (tager normalt under 10 min.).
English: It blocks the activity of another protein in the body that causes inflammation.
Danish: Det blokerer aktiviteten af et andet protein i kroppen, som forårsager inflammation (betændelse).
English: Place your other hand on the longer portion of the container.
Danish: Sæt den anden hånd på den lange del af beholderen.
English: This appearance is normal for LIFMIOR.
Danish: Dette udseende er normalt for LIFMIOR.
English: Very Rare
Danish: Meget sjælden
English: The syringes are type I glass.
Danish: Sprøjterne er af type I glas.
English: No formal clinical trials have been conducted in children aged 2 to 3 years.
Danish: Der er ikke gennemført formelle kliniske forsøg hos børn i alderen 2-3 år.
English: The difference between LIFMIOR alone and methotrexate alone was also significant (p<0.05).
Danish: Forskellen mellem LIFMIOR alene og methotrexat alene var også signifikant (p<0,05).
English: Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.
Danish: Regelmæssige hudundersøgelser anbefales for alle patienter, og især for patienter med risikofaktorer for hudkræft.
English: Differences from adults and other special considerations are discussed in the following paragraphs.
Danish: Forskellene i forhold til voksne og andre specielle faktorer omtales i følgende afsnit.
English: Simulation of dosing suggests that while older children (10-17 years of age) will have serum levels close to those seen in adults, younger children will have appreciably lower levels.
Danish: Dosissimulering antyder, at mens ældre børn (10-17 år gamle) vil have serumniveauer tæt på dem, der ses hos voksne, vil yngre børn have væsentligt lavere niveauer.
English: Follow the directions given by the doctor.
Danish: Følg lægens anvisninger.
English: The clinical significance of this is unknown.
Danish: Den kliniske betydning af dette er ukendt.
English: Patients were also required to have an inadequate response or intolerance to two or more NSAIDs.
Danish: Patienterne skulle desuden have utilstrækkeligt respons på eller være intolerante over for to eller flere NSAID.
English: With continued therapy, responses were maintained up to 48 weeks.
Danish: Med fortsat behandling blev responset fastholdt i op til 48 uger.
English: c: Remission is defined as DAS <1.6
Danish: c: Remission er definert som DAS<1,6
English: This Fc component contains the hinge, CH2 and CH3 regions, but not the CH1 region of IgG1.
Danish: Denne Fc-komponent indeholder hængslet, CH2- og CH3-regioner, men ikke CH1-området for lgG1.
English: (It may be helpful to keep notes on the location of the previous injections.)
Danish: (Det kan være en god ide at føre en fortegnelse over tidligere injektioner).
English: Continue to hold the pen firmly against your skin until you hear a second click, or until 10 seconds after the first click (whichever happens first).
Danish: Fortsæt med at holde pennen fast mod huden, indtil du hører endnu et klik, eller indtil der er gået 10 sekunder fra første klik (alt efter hvad der kommer først).