FrancophonIA/ELRC3.0 huggingface dataset:
English: Additional tests and medicines may be needed to diagnose and treat this.
Danish: Det kan være nødvendigt med ekstra prøver og lægemidler for at stille diagnosen og behandle det.
English: They may raise your risk of having heart problems.
Danish: De kan øge din risiko for at få hjerteproblemer.
English: - Tell your doctor about all your medical conditions including allergies.
Danish: - Fortæl lægen om alle dine sygdomme, også allergier.
English: What should I know about cholesterol and triglycerides?
Danish: Hvad bør jeg vide om kolesterol og triglycerider?
English: The mechanism of this interaction (whether it is pharmacodynamics or pharmacokinetic, or both) is yet unknown.
Danish: Mekanismen bag denne interaktion (hvorvidt den er farmakodynamisk eller farmakokinetisk eller begge dele) er endnu ukendt.
English: The volume of distribution is about 0.5 l/kg.
Danish: Fordelingsvolumen er ca. 0,5 l/kg.
English: - You are under 18 years old.
Danish: - Du er over 70 år gammel.
English: This is of no relevance to therapeutic use in man.
Danish: Dette har ingen relevans for den terapeutiske brug hos mennesker.
English: Adverse reactions have usually been mild and transient.
Danish: Bivirkningerne var som regel milde og forbigående.
English: This is due to the fat content of the meal.
Danish: Dette skyldes måltidets fedtindhold.
English: Your doctor will monitor you while you are taking this medicine.
Danish: Din læge vil overvåge dit helbred, imens du tager dette lægemiddel.
English: Clinical and biochemical monitoring of patients receiving this combination is recommended.
Danish: Det anbefales at foretage en klinisk og biokemisk monitorering af patienter, som får denne kombination.
English: Paediatric population (< 18 years old)
Danish: Pædiatrisk population (< 18 år)
English: Do not take Pravafenix if you are pregnant or trying to get pregnant or think you may be pregnant.
Danish: Tag ikke Pravafenix, hvis du er gravid eller forsøger at blive gravid, eller hvis du tror, at du måske kan være gravid.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Danish: Kravene til indsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel, er fastsat i listen over EU-referencedatoer (EURD liste), der er fastsat i henhold til artikel 107c(7), i direktiv 2001/83/EF, og enhver efterfølgende opdatering offentliggjort på den europæiske webportal om lægemidler.
English: The risk of muscle breakdown is greater in certain patients.
Danish: Risikoen for muskelnedbrydning er større hos nogle patienter.
English: - Children and adolescents (age below 18 years).
Danish: - Børn og unge (under 18 år).
English: If CK levels are significantly elevated > 5 times the ULN at baseline, the results should be controlled after 5-7 days.
Danish: Hvis CK-niveauerne er signifikant forhøjede, dvs. > 5 gange ULN ved baseline, bør resultaterne kontrolleres efter 5-7 dage.
English: In these cases, CK levels should be measured.
Danish: I sådanne tilfælde skal CK-niveauerne måles.
English: When the blood flow is blocked, the result can be a heart attack or stroke.
Danish: Når blodtilstrømningen blokeres, kan resultatet være et hjerteanfald eller et slagtilfælde.
English: It is recommended that the dose of anticoagulants is reduced by about one third at the start of treatment and then gradually adjusted if necessary according to INR (International Normalised Ratio) monitoring.
Danish: Det anbefales, at dosis af antikoagulantia reduceres med ca. en tredjedel i starten af behandlingen og om nødvendigt justeres gradvist i henhold til monitoreringen af INR (International Normalised Ratio).
English: This clogging can slow or block blood flow to vital organs such as the heart and brain.
Danish: Denne tilstopning kan forsinke eller blokere blodtilstrømningen til vitale organer som hjertet og hjernen.
English: In such cases CK levels should be measured (see below).
Danish: I sådanne tilfælde skal CK-niveauerne måles (se nedenfor).
English: LDL and VLDL triglycerides are reduced.
Danish: LDL- og VLDL-triglycerider reduceres.
English: Do not take a double dose to make up for a forgotten dose, just take your normal amount of Pravafenix at the usual time the next day.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis, men skal blot tage den normale mængde Pravafenix på det sædvanlige tidspunkt næste dag.
English: Pravastatin is administered orally in the active form.
Danish: Pravastatin indgives oralt i den aktive form.
English: Fatigue and vertigo
Danish: Træthed og vertigo
English: Before treatment initiation
Danish: Inden behandlingens påbegyndelse
English: It is important to take the capsule with food, as it won't work as well if your stomach is empty.
Danish: Det er vigtigt at tage kapslen med mad, eftersom den ikke virker lige så godt på tom mave.
English: Studies in mice, rats and rabbits did not reveal any teratogenic effect.
Danish: Undersøgelser hos mus, rotter og kaniner har ikke vist nogen teratogen virkning.
English: Polyamide-Aluminium-PVC/aluminium blister 2 years.
Danish: Polyamid-aluminium-PVC/aluminium blisterpakninger 2 år.
English: If you plan to become pregnant or become pregnant, inform your doctor immediately.
Danish: Hvis du planlægger at blive gravid eller bliver gravid, skal du straks fortælle det til din læge.
English: No specific antidote is known.
Danish: Der er ingen specifik modgift.
English: In clinical trials, over 1,566 patients received Pravafenix.
Danish: I kliniske undersøgelser fik over 1 566 patienter Pravafenix.
English: The baseline CK levels may also be useful as a reference in the event of a later increase during the combination therapy.
Danish: CK-niveauernes baselineværdier kan ligeledes være nyttige som reference, såfremt der sker en senere stigning under kombinationsbehandlingen.
English: Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000).
Danish: 1/100 til < 1/10), ikke almindelig (≥ 1/1 000 til < 1/100), sjælden (≥ 1/10 000 til < 1/1 000), meget sjælden (< 1/10 000).
English: This was not observed in the aforementioned subgroup of patients with dyslipidaemia but there was also no clear evidence of benefit in dyslipidaemic women treated with fenofibrate plus simvastatin, and a possible harmful effect in this subgroup could not be excluded.
Danish: Dette blev ikke observeret i den førnævnte undergruppe af patienter med dyslipidæmi, men der var heller ikke noget klart bevis for fordelen hos dyslipidæmiske kvinder behandlet med fenofibrat plus simvastatin, og en mulig skadelig effekt i denne undergruppe kunne ikke udelukkes.
English: If confirmed, the treatment should definitively not be initiated (see section 4.3).
Danish: Hvis de bekræftes, må behandlingen definitivt ikke påbegyndes (se pkt.
English: If you are concerned about how much alcohol you can drink while you are taking this medicine, you should discuss this with your doctor.
Danish: Hvis du er usikker på, hvor meget alkohol du kan drikke, mens du tager dette lægemiddel, skal du tale med din læge.
English: Maximum plasma concentrations (Cmax) occur within 4 to 5 hours after oral administration.
Danish: Maksimale plasmakoncentrationer (Cmax) optræder senest 4-5 timer efter oral indgivelse.
English: Reported cases of overdose were asymptomatic and did not give rise to abnormal laboratory tests.
Danish: De indberettede tilfælde af overdosering var asymptomatiske og gav ikke anledning til unormale laboratorieprøver.
English: HDPE bottle 3 years.
Danish: HDPE-beholdere3 år.
English: The combination has not been tested in reproductive toxicity studies.
Danish: Kombinationen er ikke blevet testet i reproduktionstoksicitetsundersøgelser.
English: On average, 34% of the orally administered dose is absorbed, with an absolute bioavailability of 17%.
Danish: I gennemsnit absorberes 34 % af den oralt indgivne dosis med en absolut biotilgængelighed på 17 %.
English: Do not take Pravafenix if any of the above applies to you.
Danish: Tag ikke Pravafenix, hvis noget af ovenstående gælder for dig.
English: Biotransformation and elimination
Danish: Biologisk omdannelse og elimination
English: - To raise the level of your ‘good' cholesterol (HDL cholesterol).
Danish: - For at øge niveauet af det "gode" kolesterol (HDL-kolesterol).
English: Plasma concentrations are stable during continuous treatment in any given individual.
Danish: Plasmakoncentrationerne er stabile under fortsat behandling hos en hvilken som helst person.
English: Although these changes were minor, caution should be exercised when associating pravastatin with erythromycin or clarithromycin.
Danish: Selv om disse ændringer var små, bør der udvises forsigtighed, når pravastatin bruges samtidig med erythromycin eller clarithromycin.
English: Over time, this plaque build-up can lead to a clogging of your arteries.
Danish: Med tiden kan dannelsen af sådanne belægninger føre til tilstopning af dine arterier.
English: Do not use Pravafenix after the expiry date which is stated on the carton and the blister/bottle after EXP.
Danish: Brug ikke Pravafenix efter den udløbsdato, der står på æsken og blisterkortet/beholderen efter EXP.
English: You should tell your doctor immediately if it happens.
Danish: Fortæl det straks til lægen, hvis denne reaktion opstår.
English: This risk, however, is outweighed by the reduction in vascular risk with statins and therefore should not be a reason for stopping statin treatment.
Danish: Denne risiko opvejes dog af, at statiner reducerer den vaskulære risiko, og bør derfor ikke være grund til seponering af statin.
English: In some patients, however, the increase in pravastatin exposure may be larger.
Danish: Hos nogle patienter kan stigningen i eksponeringen for pravastatin dog være større.
English: Also see section 4 of this leaflet.
Danish: Se også punkt 4 i denne indlægsseddel.
English: The increased risk of venous thrombotic events may be related to the increased homocysteine level, a risk factor for thrombosis and other unidentified factors.
Danish: Den øgede risiko for venøse trombotiske hændelser kan være forbundet med det øgede homocysteinniveau, som er en risikofaktor for trombose, og andre uidentificerede faktorer.
English: ∞, AUCt, and Cmax is of 111.88%, 114.06%, and 115.28% respectively.
Danish: Stigningen i AUC∞, AUCt og Cmax ligger på henholdsvis 111,88 %, 114,06 % og 115,28 %.
English: Fenofibrate Fenofibric acid is strongly bound to plasma albumin (more than 99%).
Danish: Fenofibrat Fenofibrinsyre bindes stærkt til plasmaalbumin (over 99 %).
English: If you experience any dizziness, blurred or double vision during treatment, make sure you are fit to drive and use machines before attempting to do so.
Danish: Hvis du oplever nogen form for svimmelhed, sløret syn eller dobbeltsyn under behandlingen, skal du sikre dig, at du er i stand til at føre motorkøretøj eller betjene maskiner, inden du forsøger at gøre dette.
English: Children and adolescents Do not take Pravafenix if you are under 18 years old
Danish: Børn Tag ikke Pravafenix, hvis du er under 18 år.
English: 14 hard capsules 30 hard capsules 60 hard capsules 90 hard capsules
Danish: 14 hårde kapsler 30 hårde kapsler 60 hårde kapsler 90 hårde kapsler
English: - Fusidic acid: do not take fusidic acid (a medicine for bacterial infections) while using this medicine.
Danish: - Fusidinsyre: Tag ikke fusidinsyre (et lægemiddel mod bakterieinfekioner), mens du tager dette lægemiddel.
English: The recommended dose is one capsule per day.
Danish: Den anbefalede dosis er én kapsel om dagen.
English: There is evidence that treatment with fibrates may reduce coronary heart disease events but they have not been shown to decrease all cause mortality in the primary or secondary prevention of cardiovascular disease.
Danish: Der er beviser for, at behandling med fibrater kan reducere tilfælde af koronar hjertesygdom, men de har ikke vist sig at nedsætte total mortalitet i den primære eller sekundære forebyggelse af hjerte-karsygdomme.
English: The drug is excreted mainly in the urine.
Danish: Lægemidlet udskilles hovedsagelig via urinen.
English: HDL cholesterol levels are frequently increased.
Danish: Der ses hyppigt en stigning i HDL-kolesterolniveauerne.
English: Alopecia, photosensitivity reactions
Danish: Alopeci, lysfølsomhedsreaktioner
English: Treatment discontinuation should also be considered if the muscular symptoms are severe and cause daily discomfort (whatever CK levels).
Danish: Det bør ligeledes overvejes at seponere behandlingen, hvis muskelsymptomerne er svære og giver dagligt ubehag (uanset CK-niveauerne).
English: In total, these studies enrolled 1,637 patients who have not had an adequate response to treatment with pravastatin 40 mg monotherapy or simvastatin 20 mg in Europe and in the USA.
Danish: Disse undersøgelser omfattede i alt 1.637 patienter, som ikke responderede tilstrækkeligt på behandling med pravastatin 40 mg monoterapi eller simvastatin 20 mg, i Europa og i USA.
English: In view of this substantial first pass through the liver, plasma concentrations of pravastatin have only a limited value in predicting the lipid-lowering effect.
Danish: I betragtning af denne omfattende førstepassage gennem leveren har plasmakoncentrationerne af pravastatin kun begrænset værdi, når det gælder om at forudsige den lipidsænkende virkning.
English: Pravastatin is not significantly metabolised by cytochrome P450 nor does it appear to be a substrate or an inhibitor of P-glycoprotein but rather a substrate of other transport proteins.
Danish: Pravastatin metaboliseres ikke signifikant af cytokrom P450 og lader ikke til at være et substrat eller en hæmmer af P-glycoprotein, men snarere et substrat af andre transportproteiner.
English: In vitro studies demonstrated that pravastatin is transported into hepatocytes and with substantially less intake in other cells.
Danish: In vitro-undersøgelser viste, at pravastatin transporteres ind i hepatocytterne og, med et betydeligt mindre indtag, i andre celler.
English: Sodium hydrogen carbonate Lauroyl macrogolglycerides Type 1500 Hydroxypropylcellulose Macrogol 20 000
Danish: Natriumhydrogencarbonat Lauroyl macrogolglycerider type 1500 Hydroxypropylcellulose Macrogol 20 000
English: The overall effect is a decrease in the ratio of low and very low-density lipoproteins to high-density lipoproteins.
Danish: Den generelle virkning er en reduktion i forholdet mellem lipoproteiner med lav og meget lav densitet og lipoproteiner med høj densitet.
English: Special attention should be paid to patients who develop increase in transaminase levels and therapy should be discontinued if increases in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) exceed 3 times the ULN and persist.
Danish: Der bør tages særligt hensyn til patienter, som udvikler en stigning i transaminaseniveauerne, og behandlingen bør seponeres, hvis stigningerne i aspartat-aminotransferase (ASAT) og alaninaminotransferase (ALAT) overstiger 3 gange ULN og varer ved.
English: Plasma uric acid levels are increased in approximately 20% of hyperlipidaemic patients, particularly in those with type IV disease.
Danish: Plasmaurinsyreniveauerne stiger hos ca. 20 % af hyperlipidæmipatienterne og navnlig hos dem, der har type IV-sygdom.
English: However, when driving vehicles or using machines, it should be taken into account that dizziness and visual disturbances may occur during treatment.
Danish: Hvis man fører motorkøretøj eller betjener maskiner, skal man dog tage højde for, at der kan opstå svimmelhed og synsforstyrrelser under behandlingen.
English: If cholelithiasis is suspected, gallbladder studies are indicated.
Danish: Hvis der er mistanke om cholelithiasis, er galdeblæreundersøgelser indiceret.
English: The respective effects of pravastatin and fenofibrate are complementary.
Danish: De respektive virkninger af pravastatin og fenofibrat er komplementære.
English: If a patient plans to become pregnant or becomes pregnant, the physician has to be informed immediately and pravastatin should be discontinued because of the potential risk to the foetus.
Danish: Hvis en patient planlægger at blive gravid eller bliver gravid, skal lægen straks informeres, og pravastatin skal seponeres på grund af den potentielle risiko for fosteret.
English: Fenofibrate has a uricosuric effect and is therefore of additional benefit in such patients.
Danish: Fenofibrat har en urikosurisk virkning og er derfor til yderligere gavn for sådanne patienter.
English: However in a multiple dose study, the results showed that the product is not bioequivalent because its bioavailability after multiple dosing is a 20% lower for the fenofibrate component of the combination.
Danish: I en flerdosisundersøgelse viser resultaterne dog, at lægemidlet ikke er bioækvivalent, eftersom dets biotilgængelighed efter flerdosering er 20 % lavere for kombinationens fenofibratkomponent.
English: Triglycerides are another fat in your blood.
Danish: Triglycerider er et andet fedtstof i blodet.
English: The plasma concentrations are proportional to the doses administered.
Danish: Plasmakoncentrationerne er proportionelle med de doser, der indgives.
English: The renal function of these patients must therefore be closely monitored and the treatment with fenofibrate stopped in the case of severe alteration of laboratory parameters.
Danish: Derfor er det nødvendigt at monitorere disse patienters nyrefunktion nøje og at standse behandlingen med fenofibrat, såfremt laboratorieparametrene ændrer sig kraftigt.
English: The food effect increases with the fat content: the larger the lipid content the larger the bioavailability of fenofibrate.
Danish: Virkningen af mad stiger i takt med fedtindholdet: Jo større fedtindhold, desto større er fenofibrats biotilgængelighed.
English: In a similar study with clarithromycin a statistically significant increase in AUC (110%) and Cmax (127%) was observed.
Danish: I en lignende undersøgelse med clarithromycin blev der observeret en statistisk signifikant stigning i AUC (110 %) og Cmax (127 %).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 April 2011
Danish: Dato for første markedsføringstilladelse: 14. april 2011 Dato for seneste fornyelse
English: Before you take Pravafenix you should tell your doctor if you have or have had any medical problems.
Danish: Før du tager Pravafenix, skal du fortælle det til lægen, hvis du har eller har haft nogen helbredsproblemer.
English: About 50% of circulating pravastatin is bound to plasma proteins.
Danish: Ca. 50 % af pravastatin i blodet bindes til plasmaproteiner.
English: • Muscle breakdown (rhabdomyolysis), some cases of tendon problems, sometimes complicated by rupture.
Danish: • Muskelnedbrydning (rhabdomyolyse), visse tilfælde af senelidelser, som undertiden kompliceres af brud.
English: - Known photo allergy or photo toxic reaction during treatment with fibrates or ketoprofen.
Danish: - Kendt fotoallergi eller fototoksisk reaktion under behandling med fibrater eller ketoprofen.
English: Dietary restrictions instituted before therapy should be continued.
Danish: Diætrestriktioner, der blev indført inden behandlingen, bør fortsættes.
English: Peripheral polyneuropathy
Danish: Perifer polyneuropati
English: Consequently, the potential benefit/risk ratio of Pravafenix should be closely assessed before treatment initiation and patients should be monitored for any signs of muscle toxicity.
Danish: Det er således nødvendigt med en nøje vurdering af det potentielle risk/benefit-forhold for Pravafenix, inden behandlingen indledes, og patienternes bør monitoreres for ethvert tegn på muskeltoksicitet.
English: Fibrates and statins in combination have also been shown to synergistically increase the transcriptional activities of PPARα receptors.
Danish: Det er ligeledes påvist, at en kombination af fibrater og statiner medfører en synergistisk stigning i PPARα-receptorernes transskriptionsaktiviteter.
English: Statin therapy may be re-introduced seven days after the last dose of fusidic acid.
Danish: Statinbehandlingen kan genoptages syv dage efter den sidste dosis af fusidinsyre.
English: Colestyramine/Colestipol
Danish: Kolestyramin/kolestipol
English: Animal studies have not demonstrated any teratogenic effects.
Danish: Dyreforsøg har ikke påvist teratogene virkninger.
English: Kinetic studies following the administration of a single dose and continuous treatment have demonstrated that the drug does not accumulate.
Danish: Kinetiske undersøgelser efter indgivelsen af en enkelt dosis og fortsat behandling har vist, at lægemidlet ikke akkumuleres.
English: Based on conventional studies of safety pharmacology, repeated dose toxicity and toxicity on reproduction, there are no other risks for the patient than those expected due to the pharmacological mechanism of action.
Danish: Pravastatin Konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser og reproduktionstoksicitet viser, at der ikke er andre risici for patienterne end de risici, der forventes som følge af den farmakologiske virkningsmekanisme.
English: There are no data on the excretion of fenofibrate and/or its metabolites into human breast milk.
Danish: Der er ingen data om udskillelse af fenofibrat og/eller dets metabolitter i human mælk.
English: Response to therapy should be monitored by determination of serum lipid values.
Danish: Responset på behandling bør monitoreres ved at bestemme serumlipidværdierne.
English: System organ class
Danish: System organklasse
English: Vision disturbance (including blurred vision and diplopia)
Danish: Synsforstyrrelser (herunder sløret syn og diplopi)
English: Technimede Sociedade Técnico-Medicinal S.A. Tel: +351 21 041 41 00
Danish: Tecnimede Sociedade Técnico-Medicinal S.A. Tel: +351 21 041 41 00
English: This is why medicinal products that are metabolised by, or are inhibitors of, the cytochrome P450 system can be added to a stable regimen of pravastatin without causing significant changes in the plasma levels of pravastatin, as have been seen with other statins.
Danish: Derfor kan lægemidler, som metaboliseres af eller hæmmer cytokrom P450-systemet, føjes til et stabilt pravastatinregimen uden at medføre signifikante ændringer i plasmakoncentrationerne af pravastatin, sådan som det er set med andre statiner.
English: The following statements reflect the pharmacodynamic/pharmacokinetic properties of the individual active substances of Pravafenix.
Danish: De følgende udsagn afspejler de farmakodynamiske/farmakokinetiske egenskaber for de enkelte aktive stoffer i Pravafenix.
English: Plasma elimination half-life of oral pravastatin is 1.5 to 2 hours.
Danish: Plasmaeliminationens halveringstid for oralt indgivet pravastatin er 1,5 til 2 timer.
English: The systemic clearance of pravastatin is 0.81 l/h/kg and the renal clearance is 0.38 l/h/kg indicating tubular secretion.
Danish: Pravastatins systemiske clearance er 0,81 l/h/kg, og den renale clearance er 0,38 l/h/kg, hvilket indikerer tubulær sekretion.
English: Sudden severe allergic reactions including swelling of the face, lip, tongue or wind pipe which can cause great difficulty in breathing.
Danish: Pludselige alvorlige allergiske reaktioner, herunder hævelser i ansigtet, læberne, tungen eller luftrøret, kan gøre det meget vanskeligt at trække vejret.
English: As with other lipid lowering substances, pravastatin or fenofibrate have been associated with the onset of myalgia, myopathy and very rarely rhabdomyolysis with or without secondary renal insufficiency.
Danish: Ligesom det er tilfældet med andre lipidsænkende stoffer, er pravastatin og fenofibrat blevet associeret med indtræden af myalgi, myopati og meget sjældent rhabdomyolyse med eller uden sekundær nyreinsufficiens.
English: CK levels should be measured prior to initiation of therapy.
Danish: CK-niveauerne skal måles, inden behandlingen påbegyndes.