FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment of adults with primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate.
Danish: Behandling af primær hyperkolesterolæmi eller blandet dyslipidæmi hos voksne som supplement til diæt, når diæt og andre ikke-farmakologiske behandlinger (fx motion, vægttab) er utilstrækkeligt.
English: • Secondary prevention of major cardiac events in adults with coronary heart disease (CHD)
Danish: • Sekundær forebyggelse af større hjerteanfald hos voksne med koronar hjertesygdom efter perkutan koronar intervention
English: One prolonged-release tablet of Lescol XL contains 84.24 mg fluvastatin sodium equivalent to 80 mg fluvastatin free acid.
Danish: En depottablet med Lescol XL indeholder 84,24 mg fluvastatinnatrium svarende til 80 mg fluvastatin.
English: NAME OF THE MEDICINAL PRODUCT Lescol and associated names (see Annex I) 20 mg capsules, hard Lescol and associated names (see Annex I) 40 mg capsules, hard Lescol XL and associated names (see Annex I) 80 mg prolonged-release tablets Fluvastatin
Danish: Lescol og tilhørende navne (se bilag I) 20 mg kapsler, hårde Lescol og tilhørende navne (se bilag I) 40 mg kapsler, hårde Lescol XL og tilhørende navne (se bilag I) 80 mg depottabletter Fluvastatin
English: What Lescol/Lescol XL is and what it is used for Before you take Lescol/Lescol XL How to take Lescol/Lescol XL Possible side effects
Danish: Det skal du vide, før du begynder at tage Lescol/Lescol XL Sådan skal du tage Lescol/Lescol XL Bivirkninger
English: NAME OF THE MEDICINAL PRODUCT Lescol and associated names (see Annex I) 20 mg capsules, hard Lescol and associated names (see Annex I) 40 mg capsules, hard Lescol XL and associated names (see Annex I) 80 mg prolonged-release tablets
Danish: Lescol og tilhørende navne (se bilag I) 20 mg kapsler, hårde Lescol og tilhørende navne (se bilag I) 40 mg kapsler, hårde Lescol XL og tilhørende navne (se bilag I) 80 mg depottabletter
English: Regarding section 5.3 Preclinical safety data, the MAH's proposal was amended and considered to be acceptable by the CHMP.
Danish: Prækliniske sikkerhedsdata blev forslaget fra indehaveren af markedsføringstilladelsen ændret, og udvalget anså det for at være acceptabelt.
English: Belgium Novartis Pharma N.V. Medialaan, 40 bus 1, 1800
Danish: Medialaan, 40 bus 1 1800 Vilvoorde Belgien
English: In the Lipoprotein and Coronary Atherosclerosis Study (LCAS), the effect of fluvastatin on coronary atherosclerosis was assessed by quantitative coronary angiography in male and female patients (35 to
Danish: I LCAS-studiet (Lipoprotein and Coronary Atherosclerosis Study) blev effekten af fluvastatin på koronar aterosklerose vurderet ud fra kvantitativ koronarangiografi hos mandlige og kvindelige patienter (35-75-årige) med koronar arteriesygdom og baseline LDL-C-niveauer på 3,0 til 4,9 mmol/l (115-190 mg/dl).
English: Lescol® Capsule, hard 40mg
Danish: Lescol® Capsule, hard 40 mg 40 mg Kapsel, hård
English: Laboratório NormalProdutos Farmacêuticos, S.A. Rua do Centro empresarial, Edifício 8, Quinta da Beloura 2710-444 Sintra Portugal
Danish: 8 Quinta da Beloura 2710-444 Sintra
English: - if you are allergic (hypersensitive) to fluvastatin or any of the other ingredients of Lescol/Lescol XL
Danish: Tag ikke Lescol/Lescol XL - hvis du er overfølsom (allergisk) over for fluvastatin eller et af de øvrige indholdsstoffer i
English: Secondary prevention of major adverse cardiac events in adults with coronary heart disease after percutaneous coronary interventions (see section 5.1).
Danish: Sekundær forebyggelse ved koronar hjertesygdom Sekundær forebyggelse af alvorlige kardielle hændelser hos voksne med koronar hjertesygdom efter perkutan koronar intervention (se pkt.
English: HOW TO TAKE LESCOL/LESCOL XL
Danish: SÅDAN SKAL DU TAGE LESCOL/LESCOL XL
English: 6.3 Shelf life [To be completed Nationally]
Danish: 6.3 Opbevaringstid [Udfyldes nationalt]
English: Each capsule contains 20 mg fluvastatin Each capsule contains 40 mg fluvastatin Each tablet contains 80 mg fluvastatin
Danish: Hver kapsel indeholder 80 mg fluvastatin.
English: Lescol® Capsule, hard 20mg
Danish: Lescol® Capsule, hard 20 mg 20 mg Kapsel, hård
English: 1235 Wien, Austria
Danish: 20126 Milano Italien
English: Your doctor will recommend you to follow a low-cholesterol diet. Stay on this diet while taking Lescol/Lescol XL.
Danish: Din læge vil anbefale dig at følge en diæt med lavt kolesterolindhold.
English: Lescol Exel 80 mg prolonged-release tablet
Danish: Lescol Exel 80 mg prolongedrelease tablet
English: Gastrointestinal disorders Common:
Danish: Mave-tarm-kanalen Almindelig:
English: Locol 80 mg Retardtabletten
Danish: Locol 80 mg Retardtabletten 80 mg Depottablet
English: Novartis Pharma GmbH, Brunner Strasse 59
Danish: Novartis Pharma GmbH Brunner Strasse 59 1235 Wien
English: Cardiovasular agents
Danish: Kardiovaskulære lægemidler
English: Digaril 40 mg caps
Danish: Digaril 40 mg
English: Skeletal muscle
Danish: Skeletmuskulatur
English: listed in section 6 of this leaflet.
Danish: Lescol/Lescol XL; se afsnit 6 i denne indlægsseddel.
English: Lescol®XL Prolonged-release tablet 80mg 80 mg Prolonged release tablet
Danish: Lescol®XL Prolonged-release tablet 80 mg
English: Lescol/Lescol XL and children/adolescents
Danish: Brug af Lescol/Lescol XL sammen med mad og drikke
English: 08029 Barcelona, Spain
Danish: Av. Diagonal, 507 08029 Barcelona Spanien
English: LESCOLXL 80 mg Prolonged Release Tablets 80 mg Prolonged-release tablet
Danish: LESCOLXL 80 mg Prolonged Release Tablets
English: Av. Diagonal, 507
Danish: Novartis Farmacéutica S.A. Av. Diagonal, 507
English: PHARMACOLOGICAL PROPERTIES
Danish: Galdesyrebindende lægemidler
English: Liposit Prolib 80
Danish: Liposit Prolib 80 mg
English: Lescol XL prolonged release tablet 80 mg 80 mg Prolonged-release tablet
Danish: Lescol XL Prolonged release tablet 80 mg
English: Vaditon 40 mg caps
Danish: Vaditon 40 mg
English: Liposit 40 mg caps
Danish: Liposit 40 mg
English: Lescol XL Prolonged release tablet 80mg 80 mg Film-coated tablet
Danish: Lescol XL prolonged release tablet 80 mg
English: 80 mg prolonged-release tablets Member State
Danish: 80 mg depottabletter Medlemsland
English: - if you are pregnant or breast-feeding (see “pregnany and breast-feeding”).
Danish: - hvis du er gravid eller ammer (se ”Graviditet og amning”).
English: This summary was last updated in February 2012.
Danish: Dette sammendrag blev sidst ajourført i februar 2012.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Recuvyra on 6 October 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union den 06/10/2011.
English: Other information about Recuvyra:
Danish: Andre oplysninger om Recuvyra:
English: It is given by a veterinarian.
Danish: Lægemidlet påføres af en dyrlæge.
English: If you need more information about your animal's medical condition or treatment, contact your veterinarian.
Danish: Hvis du ønsker yderligere oplysninger om dit dyrs sygdomstilstand eller behandling, skal du kontakte din dyrlæge.
English: Diarrhoea and vomiting are also common side effects.
Danish: Diarré og opkastning er også almindelige bivirkninger.
English: If symptoms develop as a result of exposure to Recuvyra, medical advice should be sought immediately.
Danish: Hvis der opstår symptomer pga. eksponering for Recuvyra, skal der straks søges lægehjælp.
English: However, small children (15kg or less) should not touch the dog for three days after the medicine has been applied, as they may be exposed to a large amount of fentanyl.
Danish: Små børn (15 kg eller derunder) må til gengæld ikke røre ved hunden i tre dage, efter lægemidlet er blevet påført, da de kan blive udsat for en stor mængde fentanyl.
English: What are the precautions for the person who gives the medicine or comes into contact with the animal?
Danish: Hvilke forholdsregler skal der træffes af den, der påfører lægemidlet eller kommer i berøring med dyret?
English: It is given once only, two to four hours before surgery, and its effects will last for at least four days.
Danish: Lægemidlet påføres kun én gang to til fire timer før operation, og det virker i mindst fire dage.
English: Recuvyra is a medicine that contains the active substance fentanyl.
Danish: Recuvyra er et lægemiddel, der indeholder det aktive stof fentanyl.
English: The recommended dose is 2.6 mg per kilogram bodyweight applied with a specially designed syringe to the skin between the shoulder blades of the dog.
Danish: Den anbefalede dosis er 2,6 mg pr. kilogram kropsvægt, der påføres på huden mellem hundens skulderblade med en særligt udformet applikator.
English: What is the risk associated with Recuvyra?
Danish: Hvilken risiko er der forbundet med Recuvyra?
English: Why has Recuvyra been approved?
Danish: Hvorfor blev Recuvyra godkendt?
English: The CVMP decided that the benefits of Recuvyra outweighed its risks and recommended that it be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Recuvyra opvejede de risici, der er forbundet dermed, og anbefalede udstedelse af markedsføringstilladelse for Recuvyra.
English: It is available as a transdermal solution (a solution applied to the skin).
Danish: Det fås som en transdermal opløsning (en opløsning, der påføres huden).
English: The active substance in Recuvyra, fentanyl, is an opioid painkiller.
Danish: Det aktive stof i Recuvyra, fentanyl, er et opioid (smertestillende middel).
English: Recuvyra was shown to be as effective as the comparator medicines with the added advantage of being easy to apply.
Danish: Det er påvist, at Recuvyra er lige så effektivt som sammenligningslægemidlerne, og at lægemidlet har den yderligere fordel, at det er nemt at påføre.
English: Recuvyra must not be used on skin that is broken or damaged due to injury or disease.
Danish: Recuvyra må ikke anvendes på revnet eller bristet hud, der skyldes kvæstelser eller sygdom.
English: The studies compared the two medicines in terms of failure rate (dogs that had to be taken off treatment due to lack of pain control) and the need for additional treatment to counteract the harmful effects of opioid medicines.
Danish: Undersøgelserne sammenlignede de to lægemidler, hvad angik fejlprocent (hunde, hvor behandlingen blev stoppet pga. manglende smertelindring) samt behov for yderligere behandling for at modvirke de skadelige virkninger, der findes ved opioide lægemidler.
English: When applied to the skin of dogs, a dose of fentanyl is rapidly absorbed into the blood stream through the blood vessels below the skin.
Danish: Når hunden får lægemidlet via huden, absorberes en dosis fentanyl hurtigt i blodet via blodkarrene under huden.
English: What is Recuvyra?
Danish: Hvad er Recuvyra?
English: Recuvyra very commonly causes sleepiness which may last for more than 24 hours after applying the medicine, and which can be associated with reduced food and water intake, decreased stool production and transient weight loss.
Danish: En meget almindelig bivirkning ved Recuvyra er søvnighed, der varer mere end 24 timer efter påføring af lægemidlet, og som kan være ledsaget af nedsat føde- og vandindtagelse, nedsat afføring og forbigående vægttab.
English: The person administering Recuvyra should avoid contact with their skin as the medicine can be absorbed by human skin and may cause reactions in people, including skin irritation.
Danish: Den person, der påfører Recuvyra, skal undgå, at lægemidlet kommer i kontakt med huden, da lægemidlet kan absorberes af huden på mennesker og forårsage reaktioner hos mennesker, f.eks. hudirritation.
English: In both studies Recuvyra was as effective as the comparator medicine in treating pain in dogs following orthopaedic or soft tissue surgery.
Danish: I begge undersøgelser var Recuvyra lige så effektiv som sammenligningslægemidlet til behandling af hunde efter ortopædisk operation eller bløddelsoperation.
English: What benefit has Recuvyra shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Recuvyra?
English: Once in the bloodstream, fentanyl acts on receptors in the brain and spinal cord to relieve pain.
Danish: Når fentanyl er gået i blodet, virker det på receptorerne i hjernen og rygmarven og lindrer smerte.
English: In two main studies, dogs undergoing orthopaedic or soft tissue surgery were either given Recuvyra or buprenorphine (another opioid painkiller) in advance of surgery to control their pain.
Danish: I to hovedundersøgelser fik hunde, der havde været udsat for ortopædisk operation eller bløddelsoperation, enten Recuvyra eller buprenorphin (et andet smertestillende middel (opioid)) før operationen som smertelindring.
English: What is Recuvyra used for?
Danish: Hvad anvendes Recuvyra til?
English: Recuvyra is used to control pain in dogs that have undergone major orthopaedic (bone) or soft tissue surgery.
Danish: Recuvyra anvendes til smertelindring af hunde, der har været udsat for en større ortopædisk operation (knogle) eller bløddelsoperation.
English: Other side effects include mild reductions in body temperature, heart rate and breathing rate for up to three days following use.
Danish: Andre bivirkninger omfatter en let nedsat kropstemperatur, hjerte- og vejrtrækningshastighed.
English: Recuvyra must not be use in dogs that are allergic to the active substance or any other ingredient.
Danish: Recuvyra må ikke anvendes til hunde, der er overfølsomme over for det aktive stof eller et eller flere af hjælpestofferne.
English: The most common symptoms associated with fentanyl overdose in people include respiratory depression, sleepiness and myosis (narrowing of the pupil in the eye).Protective equipment of clothing should be used when handling the medicine.
Danish: De mest almindelige symptomer, der forbindes med en overdosis af fentanyl hos mennesker, omfatter nedsat åndedræt, søvnighed og myosis (forsnævring af pupillen i øjet).
English: How does Recuvyra work?
Danish: Hvordan virker Recuvyra?
English: Contact with the dog's skin after application of Recuvyra should not cause problems for adults.
Danish: Der burde ikke opstå problemer hos voksne, hvis de kommer i berøring med hundens hud efter påføring af Recuvyra.
English: 15 March 2012
Danish: 15 Marts 2012
English: The application was withdrawn at ‘day 180'.
Danish: Ansøgningen blev trukket tilbage på “dag 180”.
English: It was to be available as an oral suspension (125 mg/ml).
Danish: Det var hensigten, at det skulle leveres som oral suspension (125 mg/ml).
English: In its letter notifying the Agency of the withdrawal of application, the company stated that its withdrawal was due to the prioritisation of its activities.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at tilbagetrækningen skyldtes virksomhedens prioritering af sine aktiviteter.
English: Both medicines are oral suspensions but Megestrol Alkermes was formulated so that it could be given at a lower dose to obtain the same effect.
Danish: Begge lægemidler er orale suspensioner, men Megestrol Alkermes blev formuleret således, at der kan opnås samme virkning med en lavere dosis.
English: Based on the review of the data and the company's responses to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Megestrol Alkermes could not have been approved.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen havde CHMP visse betænkeligheder og var af den foreløbige holdning, at Megestrol Alkermes ikke kunne godkendes.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Megestrol Alkermes.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at virksomheden ikke havde fremlagt tilstrækkelige oplysninger til at underbygge ansøgningen for Megestrol Alkermes.
English: This means that it was intended to be similar to a ‘reference medicine' called Megace which is already authorised in the European Union and contains the same active substance.
Danish: Det vil sige, at det var hensigten, at Megestrol Alkermes skulle svare til et “referencelægemiddel”, som allerede er godkendt i Den Europæiske Union og indeholder det samme aktive stof.
English: The active substance in Megestrol Alkermes, megestrol, is similar to a naturally occurring hormone called progesterone and is used in the treatment of certain cancers.
Danish: Det aktive stof i Megestrol Alkermes, megestrol, ligner det naturlige hormon progesteron, der anvendes til behandling af visse kræftformer.
English: Megestrol Alkermes is a medicine that contains the active substance megestrol.
Danish: Megestrol Alkermes er et lægemiddel, der indeholder det aktive stof megestrol.
English: On 6 March 2012, Alkermes Pharma Ireland Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Megestrol Alkermes, intended to treat weight loss and loss of appetite in patients with cancer or AIDS.
Danish: Den 6. marts 2012 meddelte Alkermes Pharma Ireland Ltd. officielt til Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Megestrol Alkermes til behandling af vægttab og nedsat appetit hos patienter med kræft eller aids.
English: Because Megestrol Alkermes was assessed as a hybrid generic medicine, the company presented the results of studies carried out to investigate whether it is bioequivalent to the reference medicine, Megace.
Danish: Fordi Megestrol Alkermes blev vurderet som et hybridt generisk lægemiddel, fremlagde virksomheden undersøgelser, der skulle vise at det er bioækvivalent med referencelægemidlet Megace.
English: What is Megestrol Alkermes?
Danish: Hvad er Megestrol Alkermes?
English: Megestrol Alkermes was assessed as a ‘hybrid generic medicine'.
Danish: Megestrol Alkermes blev vurderet som et “hybridt generisk lægemiddel”.
English: Based on the data submitted, the CHMP was of the opinion that the studies did not show that Megestrol Alkermes was bioequivalent to the reference medicine and therefore cannot be considered to have the same effectiveness as Megace in reversing weight loss and loss of appetite in patients with cancer and AIDS.
Danish: Det var CHMP's opfattelse, at de forelagte undersøgelser ikke viste, at Megestrol Alkermes er bioækvivalent med referencelægemidlet, og at det derfor ikke kan anses for at have samme effektivitet som Megace til at mindske vægttab og appetitnedsættelse hos patienter med kræft og aids.
English: Megestrol Alkermes was expected to be used to treat weight loss and loss of appetite in patients with cancer or AIDS.
Danish: Megestrol Alkermes forventedes anvendt til behandling af vægttab og nedsat appetit hos patienter med kræft eller aids.
English: Megestrol Alkermes is expected to work in the same way as the reference medicine, Megace.
Danish: Megestrol Alkermes forventes at virke på samme måde som referencelægemidlet Megace.
English: The company also presented a study investigating the effectiveness of Megestrol Alkermes in the treatment of weight loss and loss of appetite in patients with AIDS and data from the scientific literature supporting the use of megestrol in the treatment of weight loss and loss of appetite in patients with cancer and AIDS.
Danish: Virksomheden fremlagde desuden en undersøgelse af virkningen af Megestrol Alkermes til behandling af vægttab og nedsat appetit hos patienter med aids, samt data fra litteraturen, der støtter anvendelsen af megestrol til behandling af vægttab og nedsat appetit hos patienter med kræft og aids.
English: What was Megestrol Alkermes expected to be used for?
Danish: Hvad forventedes Megestrol Alkermes anvendt til?
English: How is Megestrol Alkermes expected to work?
Danish: Hvordan forventes Megestrol Alkermes at virke?
English: The exact way that megestrol works in the treatment of weight loss and appetite loss is not understood but megestrol may act on certain messenger substances and pathways that affect appetite.
Danish: vægttab og nedsat appetit, men muligvis virker megestrol på visse signalstoffer og signalbaner, som har indvirkning på appetitten.
English: Urticaria,
Danish: Perifert ødem,
English: Date of first authorisation: 21 November 2014 Date of latest renewal: 31 July 2019
Danish: Dato for første markedsføringstilladelse: 21 November 2014 Dato for seneste fornyelse: 31 juli 2019
English: - if you had a stroke within the last 6 months.
Danish: - hvis du har haft et slagtilfælde indenfor de seneste 6 måneder.
English: - if you have serious heart disease or recently had a heart attack within the last 90 days.
Danish: - hvis du har en alvorlig hjertesygdom eller har haft et hjerteanfald indenfor de seneste 90 dage.
English: - if you have low blood pressure or uncontrolled high blood pressure.
Danish: - hvis du har lavt blodtryk eller ukontrolleret højt blodtryk.
English: Other sources of information
Danish: Andre kilder til information
English: If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Danish: Hvis tidsfristen for en PSUR og for opdatering af RMP er sammenfaldende, kan de fremsendes samtidig.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Danish: NTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA
English: Komárom, 2900 Hungary
Danish: Komárom, 2900 Ungarn
English: However, it is not possible to definitively determine whether these events are related directly to these risk factors, to tadalafil, to sexual activity, or to a combination of these or other factors.
Danish: Det er imidlertid ikke muligt definitivt at afgøre, hvorvidt hændelserne er direkte relateret til disse risikofaktorer, til tadalafil, til seksuel aktivitet eller til en kombination af disse eller andre faktorer.
English: At therapeutic concentrations, 94% of tadalafil in plasma is bound to proteins.
Danish: Ved terapeutiske koncentrationer er 94 % af tadalafil i plasma bundet til proteiner.
English: - if you are taking riociguat.
Danish: - hvis du tager riociguat.
English: Tadalafil may still be effective up to 36 hours after taking the tablet.
Danish: Tadalafil kan stadig være virksomt op til 36 timer efter, at du har taget tabletten.
English: - if you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite.
Danish: - hvis du tager nogen form for organisk nitrat eller nitrogenoxid-donorer såsom amylnitrit.
English: The patients should be informed not to take Tadalafil Mylan in such combinations.
Danish: Patienterne skal informeres om ikke at tage Tadalafil Mylan i den slags kombinationer.
English: In addition, there was no evidence of efficacy from any of the secondary analyses performed in this study.
Danish: Der var heller ikke evidens for effektivitet fra nogen af de sekundære analyser, der blev udført i dette studie.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Danish: Lægemidlets trykte indlægsseddel skal indeholde navn og adresse på den fremstiller, som er ansvarlig for frigivelsen af den pågældende batch.
English: However, you have been given the dose of one 20 mg tablet as your doctor has decided that the recommended dose of 10 mg is too weak.
Danish: Du har fået dog fået en dosis på én 20 mg tablet, fordi din læge har vurderet, at den anbefalede dosis på 10 mg er for svag.
English: You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
Danish: Du og din partner må indlede et forspil, ligesom du ville gøre, hvis ikke du tog medicin for erektil dysfunktion.