FrancophonIA/ELRC3.0 huggingface dataset:
English: Chronic toxicity studies have yielded no relevant information about specific toxicity of fenofibrate.
Danish: Kroniske toksicitetsundersøgelser har ikke givet nogen relevante informationer om fenofibrats specifikke toksicitet.
English: Isolated cases of tendon disorders, sometimes complicated by rupture
Danish: Isolerede tilfælde af senelidelser, som undertiden kompliceres af brud
English: Medicinal products metabolised by cytochrome P450
Danish: Lægemidler, der metaboliseres af cytokrom P450
English: - Your doctor may also want you to have blood tests to check how well your liver is working after you start taking Pravafenix.
Danish: - Din læge kan også tage blodprøver for at tjekke, hvor godt din lever fungerer, efter at du er begyndt at tage Pravafenix.
English: There have been very rare reports of an immune-mediated necrotizing myopathy (IMNM) during or after treatment with some statins.
Danish: I meget sjældne tilfælde er beskrevet immunmedieret nekrotiserende myopati (IMNM) under eller efter behandling med visse statiner.
English: The absorption of fenofibrate is increased when administered with food.
Danish: Absorptionen af fenofibrat øges, når det indgives sammen med mad.
English: In rats and mice, liver tumours have been found at high dosages, which are attributable to peroxisome proliferation.
Danish: Hos rotter og mus er der fundet levertumorer ved høje doser, hvilket kan tilskrives peroxisom-proliferation.
English: This is because colestyramine or other bile acid binding resins frequently reduce the absorption of medicines when taken too closely together and so may impede the absorption of Pravafenix.
Danish: Det skyldes, at kolestyramin og andre galdesyrebindende resiner ofte reducerer absorptionen af lægemidler, når de tages for tæt på hinanden, og at de derfor kan forhindre absorptionen af Pravafenix.
English: The following statements reflect the information available on the individual active substances (fenofibrate and pravastatin).
Danish: De følgende udsagn afspejler den tilgængelige information om de enkelte aktive stoffer (fenofibrat og pravastatin).
English: After absorption, 66% of pravastatin undergoes a first-pass extraction through the liver, which is the primary site of its action and the primary site of cholesterol synthesis and clearance of LDLcholesterol.
Danish: Efter absorptionen gennemgår 66 % af pravastatin en førstepassage-ekstraktion gennem leveren, som er det primære virkningssted og det primære sted for kolesterolsyntese og clearance af LDL-kolesterol.
English: Each hard capsule contains 19 mg of lactose.
Danish: En hård kapsel indeholder 19 mg lactose.
English: When measured, CK levels should be interpreted in the context of other potential factors that can cause transient muscle damage, such as strenuous exercise or muscle trauma and repeated if necessary.
Danish: Når CK-værdierne måles, skal de fortolkes i lyset af andre potentielle faktorer, der kan medføre forbigående muskelbeskadigelse, såsom hård træning eller muskeltraumer, og de skal om nødvendigt gentages.
English: It does this by lowering the level of total cholesterol, and fatty substances called triglycerides in the blood.
Danish: Dette sker ved at sænke niveauet af total-kolesterol og af de fedtstoffer i blodet, der kaldes triglycerider.
English: As with other lipid lowering medicinal products, moderate increases in transaminase levels have been reported in some patients treated with pravastatin or fenofibrate.
Danish: Ligesom det er tilfældet med andre lipidsænkende lægemidler, er der indberetninger om moderate stigninger i aminotransferaseniveauerne hos nogle patienter, der behandles med pravastatin eller fenofibrat.
English: Firstly, with the reversible and specific competitive inhibition of HMG-CoA reductase, it effects modest reduction in the synthesis of intracellular cholesterol.
Danish: For det første fører det, med den reversible og specifikke kompetitive hæmning af HMG-CoA-reduktase, til en beskeden reduktion af syntesen for intracellulært kolesterol.
English: No unchanged fenofibrate can be detected in the plasma where the principal metabolite is fenofibric acid.
Danish: Fenofibrat Intet uændret fenofibrat kan spores i plasma, hvor hovedmetabolitten er fenofibrinsyre.
English: Studies on mutagenicity of fenofibrate have been negative.
Danish: Undersøgelser af fenofibrats mutagenicitet har været negative.
English: Both are cholesterol/lipid modifying medicines.
Danish: Begge stoffer er kolesterol-/lipidmodificerende lægemidler.
English: • Breathing problems including persistent cough/or shortness of breath or fever.
Danish: • Vejrtrækningsproblemer, herunder vedvarende hoste/eller stakåndethed eller feber.
English: • Problems with sight such as blurred or double vision.
Danish: • Synsforstyrrelser såsom sløret syn eller dobbeltsyn.
English: The presence of food in the gastrointestinal tract leads to a reduction in the bioavailability, but the cholesterol-lowering effect of pravastatin is identical whether taken with or without food.
Danish: Tilstedeværelsen af mad i mave-tarm-kanalen fører til en reduktion af biotilgængeligheden, men pravastatins kolesterolsænkende virkning er identisk, uanset om det tages med eller uden mad.
English: It is rapidly absorbed; peak serum levels are achieved 1 to 1.5 hours after ingestion.
Danish: Det absorberes hurtigt, og maksimale serumværdier opnås efter 1 til 1,5 time efter indtagelse.
English: Concomitant administration resulted in approximately 40 to 50% decrease in the bioavailability of pravastatin.
Danish: Samtidig indgivelse resulterede i en reduktion af pravastatins biotilgængelighed på ca. 40-50 %.
English: This results in an increase in the number of LDL-receptors on cell surfaces and enhanced receptor-mediated catabolism and clearance of circulating LDL-cholesterol.
Danish: Dette resulterer i en stigning i antallet af LDL-receptorer på celleoverfladerne samt en forstærket receptor-medieret katabolisme og clearance af LDL-kolesterol i blodet.
English: Co-administration of this combination may cause increased plasma concentrations of both agents.
Danish: Samtidig administration kan medføre øgede plasmakoncentrationer af begge lægemidler.
English: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Hvis lægen har fortalt dig, at du ikke tåler visse sukkerstoffer, skal du kontakte lægen, inden du tager dette lægemiddel.
English: No sign of any effect on fertility has been detected.
Danish: Der er ikke set nogen tegn på påvirkning af fertiliteten.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Presenting features can include dyspnoea, non-productive cough and deterioration in general health (fatigue, weight loss and fever).
Danish: Symptomerne kan omfatte dyspnø, ikke-produktiv hoste og generel helbredsforringelse (træthed, vægttab og feber).
English: - Before starting taking Pravafenix, you should be on a diet to lower your cholesterol.
Danish: - Før du begynder at tage Pravafenix, skal du være på en diæt, der har til formål at sænke dit kolesterolniveau.
English: SMB Technology s.a. rue du Parc Industriel 39 B-6900 Marche en Famenne Belgium
Danish: SMB Technology s.a. rue du Parc Industriel 39 B-6900 Marche en Famenne Belgien
English: If you feel any of these symptoms you should stop taking Pravafenix and inform your doctor.
Danish: Hvis du har nogen af disse symptomer, skal du holde op med at tage Pravafenix og fortælle det til din læge.
English: Rapid reduction of serum lipid levels usually follows Pravafenix treatment, but treatment should be discontinued if an adequate response has not been achieved within three months.
Danish: Efter behandling med Pravafenix sker der sædvanligvis en hurtig reduktion af serumlipidniveauerne, men behandlingen bør seponeres, hvis der ikke er opnået en tilstrækkelig respons i løbet af tre måneder.
English: In the majority of cases, liver transaminase levels have returned to their baseline value without the need for treatment discontinuation.
Danish: I de fleste tilfælde vendte levertransaminaseniveauerne tilbage til baselineværdien, uden at det var nødvendigt at seponere behandlingen.
English: The frequencies of adverse reactions are ranked according to the following: Very common ( ≥ 1/10),
Danish: Bivirkningernes hyppighed er inddelt på følgende måde: Meget almindelig (≥ 1/10), almindelig (≥
English: Additionally, fibrates have the properties to modify the size and density of LDL-C particles to make them less atherogenic.
Danish: Endvidere er fibrater i stand til at ændre LDL-C-partiklernes størrelse og densitet, så de bliver mindre aterogene.
English: - capsule shell: gelatine, indigo carmine (E132), black iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172).
Danish: - Kapselskal: gelatine, indigotin (E132), sort jernoxid (E172), titaniumdioxid (E171), gul jernoxid (E172).
English: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) lipid trial was a randomized placebo-controlled study of 5,518 patients with type 2 diabetes mellitus treated with fenofibrate in addition to simvastatin.
Danish: Indsatsen for at kontrollere kardiovaskulær risiko ved diabetes (ACCORD) lipid-forsøg var en randomiseret placebokontrolleret undersøgelse af 5.518 patienter med type 2-diabetes mellitus behandlet med fenofibrat i tillæg til simvastatin.
English: Your total cholesterol is made up mainly of LDL and HDL cholesterol.
Danish: Total-kolesterol består hovedsageligt af LDL- og HDL-kolesterol.
English: The plasma elimination half-life of fenofibric acid is approximately 20 hours.
Danish: Plasmaeliminationens halveringstid for fenofibrinsyre er ca. 20 timer.
English: • Effects on liver: raised serum transaminases.
Danish: • Bivirkninger, der vedrører leveren: forhøjede serumtransaminaser.
English: After intravenous administration, 47% of the dose is eliminated by the renal excretion and 53% by biliary excretion and biotransformation.
Danish: Efter intravenøs indgivelse elimineres 47 % af dosis via renal udskillelse og 53 % via galdeudskillelse og biologisk omdannelse.
English: The following adverse events have been reported with some statins: - Nightmares - Memory loss - Depression - Exceptional cases of interstitial lung disease, especially with long term therapy (see section 4.4).
Danish: Følgende bivirkninger er rapporteret med visse statiner: - Mareridt - Hukommelsestab - Depression - Sjældne tilfælde af interstitiel lungesygdom, navnlig ved langvarig behandling (se pkt.
English: Additional adverse reactions associated with the use of medicinal products containing pravastatin or fenofibrate observed in clinical trials and postmarketing experience that may potentially occur with Pravafenix are listed below.
Danish: Yderligere bivirkninger i forbindelse med brugen af lægemidler indeholdende pravastatin eller fenofibrat, som er observeret i kliniske undersøgelser og fra erfaringen efter markedsføringen, og som potentielt kan forekomme med Pravafenix, er nævnt nedenfor.
English: Pravafenix with food, drink and alcohol - Always take Pravafenix with food as Pravafenix is less well absorbed from an empty stomach.
Danish: Brug af Pravafenix sammen med mad og drikke - Tag altid Pravafenix sammen med mad, eftersom Pravafenix ikke absorberes lige så godt på tom mave.
English: Sleep disturbance including insomnia and nightmares
Danish: Psykiske forstyrrelser Søvnforstyrrelser, herunder søvnløshed og mareridt
English: Pravastatin is more effective in reducing LDL-C and total cholesterol but presents only modest effects on TG and HDL-C while fenofibrate is very effective in decreasing TG and increasing HDL-C, but with few effects on LDL-C.
Danish: Pravastatin er mere effektivt til at reducere LDL-C og totalt kolesterol, men har kun en beskeden indvirkning på TG og HDL-C, mens fenofibrat er meget effektivt til at reducere TG og øge HDL-C, men kun har ringe indvirkning på LDL-C.
English: In the event of an overdose, symptomatic and supportive measures should be employed.
Danish: I tilfælde af overdosering skal der iværksættes understøttende og symptomatisk behandling.
English: Since current safety and efficacy data are based upon administration with food and with dietary restrictions, it is recommended that Pravafenix is administered with food.
Danish: Eftersom de nuværende sikkerheds- og virkningsdata er baseret på indgivelse sammen med mad og med diætrestriktioner, anbefales det, at Pravafenix indgives sammen med mad (se pkt.
English: Fenofibrate enhances oral anticoagulant effect and may increase risk of bleeding.
Danish: Fenofibrat forstærker virkningen af orale antikoagulantia og kan øge risikoen for blødning.
English: Pravastatin is contraindicated during pregnancy and should be administered to women of childbearing potential only when such patients are unlikely to conceive and have been informed of the potential risk.
Danish: Pravastatin er kontraindiceret under graviditeten og bør udelukkende gives til kvinder i den fertile alder, såfremt det er usandsynligt, at sådanne patienter bliver gravide, og såfremt de er blevet informeret om den potentielle risiko.
English: • The other ingredients are: - capsule content: lactose monohydrate, cellulose microcrystalline, ascorbyl palmitate, povidone, sodium starch glycolate, magnesium stearate, talc, triacetin, sodium hydrogen carbonate, lauroyl macrogolglycerides, hydroxypropylcellulose, macrogol 20 000.
Danish: • Øvrige indholdsstoffer: - Kapslens indhold: lactosemonohydrat, mikrokrystallinsk cellulose, ascorbylpalmitat, povidon, natriumstivelsesglycolat, magnesiumstearat, talkum, triacetin, natriumhydrogencarbonat, lauroyl macrogolglycerider, hydroxypropylcellulose, macrogol 20 000.
English: • Tiredness, weakness, influenza-like illness.
Danish: • Træthed, svaghed, influenzalignende sygdom.
English: This is to check how well your liver and your kidneys are working.
Danish: Formålet med blodprøven er at tjekke, hvor godt din lever og dine nyrer fungerer.
English: Cholesterol is one of several fats found in your blood.
Danish: Kolesterol er et af de mange fedtstoffer, som dit blod indeholder.
English: Concomitant administration of pravastatin and ciclosporin leads to an approximately 4 fold increase in pravastatin systemic exposure.
Danish: Samtidig indgivelse af pravastatin og ciclosporin resulterer i, at den systemiske eksponering for pravastatin stiger ca. 4 gange.
English: In vitro and in vivo genetic toxicology studies have shown no evidence of mutagenic potential.
Danish: In vitro- og in vivo-genotoksicitetsundersøgelser viste ikke nogen evidens for mutagent potentiale.
English: Special caution is recommended in women of childbearing potential to ensure proper understanding of the potential risk associated with pravastatin therapy during pregnancy.
Danish: Det anbefales at udvise særlig forsigtighed hos kvinder i den fertile alder, så det sikres, at de er fuldstændigt klar over den potentielle risiko, der er forbundet med behandling med pravastatin under graviditeten.
English: Studies with fenofibrate on lipoprotein fractions show decreases in levels of LDL and VLDL cholesterol.
Danish: Undersøgelser af fenofibrat på lipoproteinfraktioner viser en nedgang i niveauerne af LDL- og VLDL-kolesterol.
English: In one of two interaction studies with pravastatin and erythromycin a statistically significant increase in the area under the curve (AUC) (70%) and Cmax (121%) of pravastatin was observed.
Danish: I en af to interaktionsundersøgelser med pravastatin og erythromycin blev der observeret en statistisk signifikant stigning i arealet under kurven (AUC) (70 %) og Cmax (121 %) for pravastatin.
English: Always take Pravafenix exactly as your doctor has told you.
Danish: Tag altid Pravafenix nøjagtigt efter lægens anvisning.
English: Following oral administration, 20% of the initial dose is eliminated in the urine and 70% in the faeces.
Danish: Efter oral indgivelse elimineres 20 % af initialdosis via urinen og 70 % via fæces.
English: Pravastatin is not metabolised to a clinically significant extent by the cytochrome P450 system.
Danish: Pravastatin metaboliseres ikke i et klinisk signifikant omfang af cytokrom P450-systemet.
English: HDL cholesterol is often called ‘good' cholesterol because it helps keep the ‘bad' cholesterol from building up in the arteries and because it protects against heart disease.
Danish: HDL-kolesterol kaldes ofte det "gode" kolesterol, fordi det er med til at forhindre det "dårlige" kolesterol i at sætte sig i arterierne, og fordi det beskytter mod hjertesygdom.
English: The major degradation product of pravastatin is the 3-αhydroxy isomeric metabolite.
Danish: Størstedelen af pravastatins nedbrydningsprodukt udgøres af den isomeriske 3-α-hydroxy-metabolit.
English: Frequency categories are based on information available from pravastatin and fenofibrate Summary of Product characteristics available in the EU.
Danish: Hyppighedskategorierne er baseret på tilgængelig information fra resuméer af produktkarakteristika for pravastatin og fenofibrat i EU.
English: Fenofibrate may increase cholesterol excretion into the bile, potentially leading to cholelithiasis.
Danish: Fenofibrat kan øge kolesteroludskillelsen i galden, hvilket potentielt kan føre til cholelithiasis.
English: Skin rash, Scalp/hair abnormality (including alopecia)
Danish: Hududslæt, abnormiteter i hår/hovedbund (herunder alopeci)
English: • Hypersensitivity.
Danish: • Overfølsomhed.
English: Prior to initiating Pravafenix, secondary causes of combined dyslipidaemia should be excluded and patients should be placed on a standard cholesterol and triglycerides-lowering diet which should be continued during treatment.
Danish: Inden behandlingen med Pravafenix indledes, bør sekundære årsager til kombineret dyslipidæmi udelukkes, og patienterne bør sættes på en standard kolesterol- og triglyceridsænkende diæt, som fortsættes under behandlingen.
English: It contains two active substances: pravastatin and fenofibrate.
Danish: Det indeholder to aktive stoffer: pravastatin og fenofibrat.
English: If a hereditary muscular disease is suspected in such patients, restarting Pravafenix therapy is not recommended.
Danish: Hvis der er mistanke om en arvelig muskelsygdom hos sådanne patienter, anbefales det ikke at genoptage behandlingen med Pravafenix.
English: If you stop taking Pravafenix Do not stop taking Pravafenix without first discussing it with your doctor.
Danish: Hvis du holder op med at tage Pravafenix Hold ikke op med at tage Pravafenix uden at tale med lægen først.
English: The most commonly reported adverse reactions (ADRs) during Pravafenix therapy are increased transaminase and gastrointestinal disorders.
Danish: De hyppigst rapporterede bivirkninger (ADR'er) under behandling med Pravafenix, er forøget transaminase og gastrointestinale lidelser.
English: The risk of myopathy including rhabdomyolysis may be increased by the concomitant administration of systemic fusidic acid with statins.
Danish: Risikoen for myopati, herunder rabdomyolyse, kan være højere ved samtidig administration af systemisk fusidinsyre og statiner.
English: For any information over this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil have yderligere oplysninger om Docetaxel Teva, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Fenofibrate is a fibric acid derivative whose lipid modifying effects reported in humans are mediated via activation of Peroxisome Proliferator Activated Receptor type alpha (PPARα).
Danish: Fenofibrat er et fibrinsyrederivat, hvis rapporterede lipidmodificerende effekt hos mennesker medieres ved aktivering af peroxisom proliferator-aktiveret receptor af alfa-typen (PPARα).
English: In both healthy subjects and patients with hypercholesterolaemia, pravastatin lowers the following lipid values: total cholesterol, LDL-cholesterol, apolipoprotein B, VLDL-cholesterol and triglycerides; while HDL-cholesterol and apolipoprotein A are elevated.
Danish: Hos både raske personer og patienter med hyperkolesterolæmi sænker pravastatinnatrium følgende lipidværdier: totalt kolesterol, LDL-kolesterol, apolipoprotein B, VLDL-kolesterol og triglycerider, mens HDL-kolesterol og apolipoprotein A øges.
English: Rare side effects (may affect up to 1 in 1,000 people) • Decrease in haemoglobin (oxygen-carrying pigment in blood) and leukocytes (white blood cells).
Danish: Sjældne bivirkninger (forekommer hos 1 til 10 ud af 10 000 patienter) • Reduceret hæmoglobin (iltbærende pigment i blodet) og leukocytter (hvide blodlegemer).
English: Pravafenix contains fenofibrate and pravastatin, which have different modes of action and show additive effects in terms of reduction of serum lipid.
Danish: Pravafenix indeholder fenofibrat og pravastatin, som har forskellige virkningsmekanismer og har en additiv effekt, hvad angår reduktion af serumlipid.
English: Check with your doctor or pharmacist before taking Pravafenix if you have severe respiratory failure, e.g. you have breathing problems including, persistent non-productive cough, deterioration in general health like fatigue (tiredness), weight loss and/or shortness of breath or fever.
Danish: Tal med lægen eller apoteket, inden du tager Pravafenix, hvis du har svært nedsat åndedrætsfunktion, f.eks. hvis du har vejrtrækningsproblemer, der omfatter vedvarende ikke-produktiv (tør) hoste, generel helbredsforringelse såsom træthed, vægttab og/eller stakåndethed eller feber.
English: Patients at risk (fasting glucose 5.6 to 6.9 mmol/L, BMI>30kg/m 2, raised triglycerides, hypertension) should be monitored both clinically and biochemically according to national guidelines.
Danish: Risikopatienter (fasteglukose 5,6 til 6,9 mmol/l, BMI > 30 kg/m2, forhøjede triglycerider, hypertension) bør monitoreres både klinisk og biokemisk i henhold til nationale retningslinjer.
English: In interaction studies, no statistically significant differences in bioavailability were observed when pravastatin was administered with acetylsalicylic acid, antacids (when given one hour prior to pravastatin), nicotinic acid or probucol.
Danish: I interaktionsundersøgelser er der ikke observeret nogen statistisk signifikante forskelle i biotilgængeligheden, når pravastatin blev indgivet samtidig med acetylsalicylsyre, antacida (når de blev indgivet en time inden pravastatin), nikotinsyre eller probucol.
English: There was no clinically significant decrease in bioavailability or therapeutic effect when pravastatin was administered one hour before or four hours after colestyramine or one hour before colestipol.
Danish: Der var ingen klinisk signifikant reduktion af biotilgængeligheden eller den terapeutiske virkning, når pravastatin blev indgivet en time før eller fire timer efter kolestyramin eller en time før kolestipol.
English: The safety of concomitant administration of pravastatin and fenofibrate was assessed in rats.
Danish: Sikkerheden af samtidig indgivelse af pravastatin og fenofibrat blev vurderet hos rotter.
English: The risk of muscle toxicity is increased when a fibrate and a 3-hydroxy-3-methyl-glutarylCoenzyme A (HMG-CoA) reductase inhibitor are administered together.
Danish: Risikoen for muskeltoksicitet øges, når et fibrat og en 3-hydroxy-3-methyl-glutaryl-coenzym A (HMG-CoA)-reduktasehæmmer indgives samtidig.
English: This occurrence may represent a failure of efficacy in patients with severe hypertriglyceridaemia, a direct medicinal product effect, or a secondary phenomenon mediated through biliary tract stone or sludge formation, resulting in the obstruction of the common bile duct.
Danish: Denne forekomst kan repræsentere en manglende virkning hos patienter med svær hypertriglyceridæmi, en direkte lægemiddelvirkning eller et sekundært fænomen, der er opstået som følge af dannelsen af galdesten eller -slam, som resulterer i obstruktion af den almindelige galdegang.
English: In elderly patients, the fenofibric acid apparent total plasma clearance is not modified.
Danish: Hos ældre patienter ændres den umiddelbare totale plasmaclearance for fenofibrinsyre ikke.