FrancophonIA/ELRC3.0 huggingface dataset:
English: For practical information about using Mysimba, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Mysimba, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The main measures of effectiveness were the percentage reduction in body weight over 28 or 56 weeks of treatment, and the proportion of patients who achieved at least a 5% weight reduction; the studies also looked at the number of patients who achieved at least a more stringent 10% reduction in weight, and the results were analysed using various methods to take account of the number of patients who did not complete the studies (around 50% over one year).
Danish: I undersøgelserne registreredes desuden det antal patienter, der opnåede et vægttab på mindst 10 %, og resultaterne blev analyseret med forskellige metoder, der tog hensyn til det antal patienter, der ikke gennemførte undersøgelserne (ca. 50 % i løbet af et år).
English: About 13 to 22% of those taking Mysimba achieved at least a 10% reduction in weight, while 5 to 6% of placebotreated patients did so.
Danish: Ca. 13-22 % af de patienter, der fik Mysimba, opnåede et vægttab på mindst 10 %, sammenholdt med 5-6 % af dem, der fik placebo.
English: How is Mysimba used?
Danish: Hvordan anvendes Mysimba?
English: Mysimba must not be used in certain patients at particular risk of side effects, including patients with severely reduced kidney or liver function, those with high blood pressure that is not under control,
Danish: Mysimba må ikke anvendes hos visse patienter med særlig risiko for bivirkninger, herunder patienter med svært nedsat nyre- eller leverfunktion eller ukontrolleret højt blodtryk, patienter, der nogensinde har haft krampeanfald, visse psykiske problemer eller hjernesvulster, eller som er under afvænning fra alkohol eller visse narkotika.
English: Patients should have their response and tolerability to the medicine checked regularly and treatment should be stopped in patients who have certain side effects such as an increase in blood pressure.
Danish: Behandlingen bør standses, hvis patienten får visse bivirkninger såsom blodtryksstigning.
English: What benefits of Mysimba have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Mysimba?
English: How does Mysimba work?
Danish: Hvordan virker Mysimba?
English: In three of the studies, the average weight loss in patients treated with Mysimba was around 3.7 to 5.7%, compared with 1.3 to 1.9% with placebo; the proportion of Mysimba-treated patients who achieved 5% weight loss ranged from 28 to 42% compared with 12 to 14% with placebo.
Danish: I tre af undersøgelserne var det gennemsnitlige vægttab hos de Mysimba-behandlede ca. 3,7-5,7 %, sammenholdt med 1,3 til 1,9 % for de placebobehandlede.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that although the effectiveness of the medicine in promoting weight loss was limited, it was sufficient to be clinically significant, and mandatory re-assessment of treatment after 4 months should ensure that the medicine only continues to be used in those in whom the medicine provides adequate benefit.
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) fandt, at lægemidlets evne til at bevirke vægttab var begrænset, men tilstrækkelig til at have klinisk betydning.
English: 26 July 2012
Danish: Den 26. juli 2012
English: It has been authorised in the EU since April 2004.
Danish: Det har været godkendt i EU siden april 2004.
English: The full European Public Assessment Report for Velcade can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige europæiske offentlige vurderingsrapport for Velcade findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It blocks the proteasome, which is a system within cells that breaks down proteins when they are no longer needed.
Danish: Det blokerer proteasomet, som er cellernes system til nedbrydning af proteiner, der ikke længere er brug for.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersø gelse med Velcade og har behov for mere information om din behandling, bedes du kontakte den læge, der giver dig behandlingen.
English: What was Velcade expected to be used for?
Danish: Hvad forventedes Velcade anvendt til?
English: The CHMP had concerns about the methodology used to analyse the results, which left some uncertainties about the size of the effect seen.
Danish: CHMP havde forbehold over for de metoder, der var anvendt til at analysere resultaterne, da de efterlod usikkerhed om, hvor stor virkning der var iagttaget.
English: What is happening with Velcade for the treatment of multiple myeloma?
Danish: Hvad vil der ske med brugen af Velcade til behandling af myelomatose?
English: When the proteins in cancer cells, such as the proteins that control the growth of the cells, are not broken down, the cells are affected and eventually die.
Danish: Når kræftcellernes mister evnen til at nedbryde proteiner, f.eks. de proteiner, der kontrollerer cellernes vækst, vil cellerne blive påvirket, så de til sidst dør.
English: After the CHMP had assessed the company's responses to its first round of questions, there were still some unresolved issues.
Danish: Efter at CHMP havde vurderet virksomhedens besvarelse af den første runde af spørgsmål, var der stadig nogle uafklarede punkter.
English: The Committee considered that this difference was unlikely to be relevant and was not convinced that a sub-group of patients had been identified who would benefit more from the addition of Velcade to rituximab.
Danish: Udvalget anså denne forskel for næppe at være relevant og var ikke overbevist om, at der var udpeget en undergruppe af patienter, som ville få større gavn af Velcade som tillægsbehandling til rituximab.
English: It is given in combination with melphalan and prednisone (other medicines for multiple myeloma) to patients who have not been treated before and who are not suitable for high-dose chemotherapy with a bone marrow transplant.
Danish: Det gives i kombination med melfalan og prednison (andre lægemidler mod myelomatose) til patienter, der ikke har været behandlet før og ikke er egnede til højdosis-kemoterapi med knoglemarvstransplantation.
English: There are no consequences on the use of Velcade in its authorised indications.
Danish: Afgørelsen vil ikke få konsekvenser for anvendelsen af Velcade til de godkendte indikationer.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Danish: Ansøgningen blev trukket tilbage, efter at CHMP havde vurderet den dokumentation, som virksomheden havde indsendt, og stillet en række spørgsmål.
English: The CHMP questioned the relevance of the study results which showed that, overall, patients treated with Velcade plus rituximab lived without their disease getting worse for an average of 1.8 months longer than patients treated with rituximab alone (12.8 months compared with 11 months).
Danish: CHMP betvivlede relevansen af undersøgelsens resultater, der viste, at de patienter, der var blevet behandlet med Velcade plus rituximab, samlet levede uden forværring af sygdommen 1,8 måneder længere end dem, der blev behandlet med rituximab alene (12,8 måneder mod 11 måneder).
English: Velcade is a medicine given by injection that contains the active substance bortezomib.
Danish: Velcade er et lægemiddel, der indeholder det aktive stof bortezomib.
English: The CHMP was also concerned that the combination of Velcade and rituximab caused more side effects than rituximab alone.
Danish: CHMP var desuden betænkelig ved, at kombinationen af Velcade og rituximab gav flere bivirkninger end rituximab alene.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Velcade.
Danish: Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser med Velcade.
English: It is also used on its own in patients whose disease is progressive and who have failed to respond to at least one other treatment and have already had, or cannot undergo, a bone marrow transplant.
Danish: Det anvendes desuden som selvstændig behandling af patienter, hos hvem sygdommen er fremadskridende, og hvor mindst én anden behandling har slået fejl, og som har fået knoglemarvstransplantation eller ikke kan få det.
English: In its official letter, the company stated that it decided to withdraw the application because the CHMP considered that the data provided did not support a positive benefit-risk balance.
Danish: I sit officielle brev erklærede virksomheden, at den havde besluttet at trække ansøgningen tilbage, fordi CHMP fandt, at forholdet mellem fordele og risici ikke er positivt efter de forelagte oplysninger.
English: The main measure of effectiveness was progression free survival (how long the patients lived without their disease getting worse).
Danish: Behandlingens virkning blev hovedsagelig bedømt på, hvor længe patienterne overlevede uden forværring af sygdommen.
English: It is used to treat patients with multiple myeloma (a cancer of the plasma cells in the bone marrow).
Danish: Det anvendes til behandling af myelomatose (kræft udgående fra plasmacellerne i knoglemarven).
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Velcade in the treatment of relapsed follicular non-Hodgkin lymphoma did not outweigh its risks.
Danish: På tidspunktet for tilbagetrækningen fandt CHMP derfor, at fordelene ved Velcade til behandling af tilbagefald af follikulært non-Hodgkins lymfom ikke er større end risiciene.
English: In relapsed follicular non-Hodgkin lymphoma, Velcade was expected to work in the same way as it does in its existing indications.
Danish: Ved tilbagefald af non-Hodgkins follikulært lymfom forventedes Velcade at virke på samme måde som ved de eksisterende anvendelser.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Velcade eller i programmer for anvendelse af Velcade med særlig udleveringstilladelse?
English: How was Velcade expected to work?
Danish: Hvordan forventedes Velcade at virke?
English: On 2 July 2012, Janssen-Cilag International N.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation of Velcade, which would have extended its use to patients with relapsed follicular non-Hodgkin lymphoma.
Danish: officielt til Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om ændring af markedsføringstilladelsen for Velcade med henblik på tilføjelse af anvendelse til patienter med tilbagefald af nonHodgkins follikulært lymfom.
English: The applicant presented the results of a study involving 676 patients with follicular non-Hodgkin lymphoma that had relapsed or progressed despite previous treatments, designed to assess the effects of using Velcade in combination with rituximab compared with using rituximab alone in these patients.
Danish: Ansøgeren forelagde resultaterne af en undersøgelse med 676 patienter med non-Hodgkins follikulært lymfom, hos hvem sygdommen var vendt tilbage eller skredet frem trods forudgående behandling.
English: Velcade was also expected to be used in follicular non-Hodgkin lymphoma (a cancer of the lymph tissue (part of the immune system) that affects a type of white blood cell called B lymphocytes, or B cells), in combination with another medicine called rituximab in patients whose disease had relapsed (returned after treatment).
Danish: Denne kræftform udgår fra lymfevæv (en del af immunsystemet) og angriber hvide blodlegemer af typen B-lymfocytter eller B-celler.
English: Date of first authorisation: 06/11/2017.
Danish: Dato for første tilladelse: 06/11/2017.
English: Anaphylactic reactions have been reported in very rare cases.
Danish: Anafylaktiske reaktioner er rapporteret i meget sjældne tilfælde.
English: After the second injection, and subsequent administrations, this reaction is markedly reduced.,
Danish: Efter den anden og efterfølgende injektioner, reduceres denne reaktion markant.
English: 1ère avenue 2065 m LID 06516 Carros France
Danish: 1ère avenue 2065 m LID 06516 Carros Frankrig
English: PSUR submissions for Nobivac LeuFel shall be synchronised and submitted at the same frequency as for LEUCOGEN.
Danish: PSUR'er for Nobivac LeuFel skal synkroniseres og indsendes med samme hyppighed som for LEUCOGEN.
English: Primary vaccination: - first injection in kittens from eight weeks of age - second injection 3 or 4 weeks later.
Danish: Basisvaccination: - første injektion fra killingerne er 8 uger gamle - anden injektion: 3 til 4 uger senere.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Adjuvants: 3% aluminium hydroxide gel expressed as mg Al
Danish: Adjuvanser: 3% aluminiumhydroxidgel udtrykt som mg Al
English: Box of 10 or 50 vials
Danish: ÆSKE MED 10 ELLER 50 HÆTTEGLAS
English: Excipients: Buffered isotonic solution to 1 ml.
Danish: Hjælpestoffer : Isotonisk bufferopløsning op til 1 ml
English: Plastic or cardboard box of 10 vials.
Danish: Plast- eller kartonæske med 10 hætteglas.
English: Type I glass vials containing one dose (1 ml) of the vaccine closed with a 13 mm-diameter butyl elastomer stopper and aluminium capsule.
Danish: Hætteglas af type I glas indeholdende 1 dosis (1 ml) vaccine, lukket med en 13 mm-diameter butylelastomer prop, fastgjort med en aluminiumskapsel.
English: Incompatibilities: Do not mix with any other veterinary medicinal products except FELIGEN RCP or FELIGEN CRP.
Danish: Uforligeligheder: Må ikke blandes med andre lægemidler til dyr undtaget FELIGEN CRP eller FELIGEN RCP.
English: Plastic or cardboard box of 50 vials.
Danish: Plast- eller kartonæske med 50 hætteglas.
English: Active substance: Minimum quantity of purified p45 FeLV-envelope antigen
Danish: Aktivt stof : Minimumsmængde af renset p45-FeLV-envelope-antigen
English: Vial label
Danish: HÆTTEGLAS ETIKET
English: Do not mix with any other veterinary medicinal products except FELIGEN RCP or FELIGEN CRP.
Danish: Må ikke blandes med lægemidler til dyr undtaget FELIGEN CRP eller FELIGEN RCP.
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with FELIGEN CRP or FELIGEN RCP.
Danish: Der foreligger oplysninger om sikkerhed og virkning, som påviser, at vaccinen kan blandes med og anvendes samtidig med FELIGEN CRP eller FELIGEN RCP.
English: Excipients: Buffered isotonic solution to
Danish: Hjælpestoffer: Isotonisk bufferopløsning
English: Per dose of 1 ml:
Danish: Dosis svarende til 1 ml indeholder :
English: Active substance: Minimum quantity of purified p45 FeLV-envelope antigen 102 µg
Danish: Aktivt stof: Minimumsmængde af renset p45-FeLV-envelope-antigen
English: Pain at palpation, sneezing or conjunctivitis may be noted in rare cases.
Danish: I sjældne tilfælde kan der forekomme let smerte ved palpation, nysen eller konjunktivitis.
English: Nobivac LeuFel suspension for injection for cats
Danish: Nobivac LeuFel injektionsvæske, suspension til katte
English: PACKAGE LEAFLET Nobivac LeuFel suspension for injection for cats
Danish: INDLÆGSSEDDEL : Nobivac LeuFel injektionsvæske, suspension til katte.
English: België/Belgique/Belgien INTERVET INTERNATIONAL BV Wim de Körverstraat 35, P.O.
Danish: België/Belgique/Belgien INTERVET INTERNATIONAL BV Wim de Körverstraat 35, P.O. Box 50
English: Luxembourg/Luxemburg INTERVET INTERNATIONAL BV Wim de Körverstraat 35, P.O.
Danish: Luxembourg/Luxemburg INTERVET INTERNATIONAL BV Wim de Körverstraat 35, P.O. Box 50
English: 102 µg FeLV
Danish: 102 mikrog
English: Marketing authorisation holder and manufacturer responsible for the batch release
Danish: Indehaver af markedsføringstilladelsen og fremstiller af batchfrigivelse :
English: Slovenská republika INTERVET INTERNATIONAL BV Wim de Körverstraat 35, P.O.
Danish: Slovenská republika INTERVET INTERNATIONAL BV Wim de Körverstraat 35, P.O. Box 50
English: Република България INTERVET INTERNATIONAL BV Wim de Körverstraat 35, P.O.
Danish: Република България INTERVET INTERNATIONAL BV Wim de Körverstraat 35, P.O. Box 50
English: ivabradine
Danish: ivabradin
English: In stable angina, these symptoms occur during physical effort.
Danish: Ved stabil angina forekommer disse symptomer under fysisk anstrengelse.
English: When used for angina, treatment should be stopped if symptoms do not improve after 3 months.
Danish: Ved anvendelse mod angina bør behandlingen standses, hvis der ikke er bedring i symptomerne efter tre måneder.
English: The full EPAR for Ivabradine JensonR can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Ivabradine JensonR findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In patients over 75 years old, a lower starting dose of 2.5 mg twice a day can be used.
Danish: Hos patienter på over 75 år kan der anvendes en lavere startdosis på 2,5 mg to gange dagligt.
English: It is used in combination with standard therapy which can include a beta-blocker.
Danish: Det anvendes i kombination med standardbehandling, som kan omfatte en betablokker.
English: Also, the doctor should consider stopping treatment if the medicine has only a limited effect on reducing symptoms or reducing the heart rate.
Danish: Lægen bør desuden overveje at standse behandlingen, hvis lægemidlet kun i begrænset omfang er i stand til at mindske symptomerne eller nedsætte hjertefrekvensen.
English: Ivabradine JensonR is available as tablets (5 and 7.5 mg) and can only be obtained with a prescription.
Danish: Ivabradine JensonR fås som tabletter (5 og 7,5 mg) og udleveres kun mod recept.
English: Treatment must be stopped if the heart rate decreases persistently below 50 beats per minute or if symptoms of bradycardia (slow heart rate) continue.
Danish: Behandlingen skal standses, hvis hjertefrekvensen vedholdende er lavere end 50 slag i minuttet, eller hvis den langsomme hjertefrekvens (bradykardi) fortsætter.
English: It is used either in patients who cannot take beta-blockers (another type of medicine to treat angina) or in combination with a beta-blocker in patients whose disease is not controlled by a beta-blockers alone.
Danish: Det anvendes enten hos patienter, der ikke kan behandles med betablokkere (en anden type lægemidler mod angina), eller kombineret med betablokkere hos patienter, hvis sygdom ikke kan kontrolleres med betablokkere alene.
English: This means that Ivabradine JensonR is similar to a ‘reference medicine' already authorised in the European Union (EU) called Procoralan.
Danish: Det betyder, at Ivabradine JensonR svarer til et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Procoralan.
English: This is a summary of the European public assessment report (EPAR) for Ivabradine JensonR.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ivabradine JensonR.
English: The medicine is used in patients with a normal heart rhythm whose heart rate is at least 70 beats per minute.
Danish: Lægemidlet anvendes hos patienter med normal hjerterytme og en hjertefrekvens på mindst 70 slag i minuttet.
English: The Committee recommended that Ivabradine JensonR be approved for use in the EU.
Danish: Udvalget anbefalede, at Ivabradine JensonR godkendes til anvendelse i EU.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ivabradine JensonR has been shown to have comparable quality and to be bioequivalent to Procoralan.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Ivabradine JensonR er af sammenlignelig kvalitet og er bioækvivalent med Procoralan.
English: Ivabradine JensonR is also used in patients with long-term heart failure (when the heart cannot pump enough blood to the rest of the body) and a normal heart rhythm whose heart rate is at least 75 beats per minute.
Danish: Ivabradine JensonR anvendes desuden til patienter med kronisk hjertesvigt (når hjertet ikke kan pumpe tilstrækkeligt med blod til resten af kroppen) og normal hjerterytme samt en hjertefrekvens på mindst 75 slag i minuttet.
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: Ivabradine JensonR 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 (heart disease caused by blockage of the blood vessels that supply the heart muscle).
Danish: Ivabradine JensonR er et hjertelægemiddel, der anvendes til at behandle symptomer på kronisk stabil angina (smerter i brystet, kæben og ryggen, som opstår ved fysisk anstrengelse) hos voksne med hjertesygdom forårsaget af blokering af blodkarrene til hjertemusklen (koronararteriesygdom).
English: Ivabradine JensonR contains the active substance ivabradine.
Danish: Ivabradine JensonR indeholder det aktive stof ivabradin.
English: By lowering the heart rate, Ivabradine JensonR reduces the stress on the heart, thereby slowing the progression of heart failure and improving symptoms.
Danish: Ved at sænke hjertefrekvensen nedsætter Ivabradine JensonR belastningen af hjertet og bremser dermed forløbet af hjertesvigt og giver mindsker symptomerne.
English: For more information about treatment with Ivabradine JensonR, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ivabradine JensonR, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What measures are being taken to ensure the safe and effective use of Ivabradine JensonR?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ivabradine JensonR?
English: Because Ivabradine JensonR is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Ivabradine JensonR er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: The active substance in Ivabradine JensonR, ivabradine, blocks the ‘If current' in the sinus node, the natural ‘pacemaker' regulates the heart rate.
Danish: Det aktive stof i Ivabradine JensonR, ivabradin, virker ved at blokere "If-strømmen" i sinusknuden, som er hjertets naturlige "pacemaker", der kontrollerer hjertefrekvensen.
English: What is Ivabradine JensonR and what is it used for?
Danish: Hvad er Ivabradine JensonR, og hvad anvendes det til?
English: It is not intended to provide practical advice on how to use Ivabradine JensonR.
Danish: Det er ikke en praktisk vejledning i, hvordan Ivabradine JensonR bør anvendes.