FrancophonIA/ELRC3.0 huggingface dataset:
English: Aluminium/Aluminium blisters: 18 months.
Danish: Aluminium/aluminium blister: 18 måneder.
English: (See section 4.4).
Danish: (angivet i punkt 6).
English: The combination has not been tested in reproductive toxicity studies.
Danish: Kombinationen er ikke testet i reproduktionstoksicitetsundersøgelser.
English: This clogging can slow or block blood flow to vital organs such as the heart and brain.
Danish: Denne tilstopning kan sænke eller blokere blodtilførslen til livsvigtige organer som hjerte og hjerne.
English: • you have high blood sugar or diabetes.
Danish: • De har forhøjet blodsukker eller diabetes.
English: • you have low levels of phosphorus.
Danish: • De har lav koncentration af fosfor.
English: Caution should be exercised in patients with pre-disposing factors for rhabdomyolysis.
Danish: Forsigtighed bør udvises hos patienter med prædisponerende faktorer for rhabdomyolyse.
English: If flushing occurs, symptoms are generally most noticeable at first and usually lessen over time.
Danish: Hvis rødmen forekommer, er symptomerne generelt mest tydelige i starten og aftager normalt med tiden.
English: • midazolam, a medicine to make you sleepy before some medical procedures.
Danish: • Midazolam, medicin der bruges til at gøre Dem søvnig før lægelige indgreb.
English: There is no experience with doses of laropiprant above 900 mg in humans.
Danish: Der er ingen erfaring med doser af laropiprant over 900 mg hos mennesker.
English: • Take Pelzont with food.
Danish: • Tag Pelzont sammen med mad.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 3 July 2008
Danish: Dato for første markedsføringstilladelse: 3. juli 2008
English: • you are going to have an operation.
Danish: • De skal opereres.
English: Laropiprant is a potent and selective antagonist of DP1.
Danish: Laropiprant er en potent og selektiv antagonist til DP1.
English: Northumberland NE23 3JU United Kingdom
Danish: Northumberland NE23 3JU Storbritannien
English: Side effects of Pelzont are:
Danish: Pelzonts bivirkninger er:
English: In general, the between-group treatment effects on all lipid parameters were consistent across all patient subgroups examined.
Danish: Generelt var behandlingseffekten på alle lipidparametre imellem grupperne konsistent på tværs af alle undersøgte patientundergrupper.
English: If you have these symptoms talk to your doctor immediately.
Danish: Hvis De har disse symptomer, skal De straks kontakte lægen.
English: • Your doctor should do a blood test before you start taking Pelzont to check how well your liver is working.
Danish: • Lægen bør tage en blodprøve, før De begynder at tage Pelzont for at kontrollere, hvor godt Deres lever virker.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/460/012
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/460/012
English: When the blood flow is blocked, the result can be a heart attack or stroke.
Danish: Når blodtilførslen blokeres, kan det resultere i et hjerte- eller slagtilfælde.
English: Diabetic or potentially diabetic patients should be observed closely.
Danish: Diabetikere eller potentielle diabetikere bør observeres.
English: Though total mortality was similar in the two groups at five years, in a fifteen-year cumulative follow-up there were 11 % fewer deaths in the nicotinic acid group compared to the placebo cohort.
Danish: Selvom total mortalitet var den samme i de to grupper efter fem år, var der i en 15-årig kumulativ follow-up-undersøgelse 11 % færre dødsfald i nicotinsyregruppen sammenlignet med placebokohorten.
English: Do not take Pelzont if
Danish: Tag ikke Pelzont hvis
English: • Personal or familial history of hereditary muscular disorders
Danish: • Personlig eller familiær historie med arvelige muskelsygdomme.
English: The tablets should be taken whole, with food, in the evening or at bedtime.
Danish: Tabletterne bør tages sammen med mad, om aftenen eller ved sengetid.
English: Laropiprant is not expected to inhibit the production of prostaglandins.
Danish: Laropiprant forventes ikke at hæmme produktionen af prostaglandiner.
English: Flushing is most prominent in the head, neck, and upper torso.
Danish: Flushing er mest fremtrædende i hovedet, på halsen og den øverste del af kroppen.
English: Talk with your doctor before taking Pelzont if:
Danish: Tal med lægen, før De tager Pelzont hvis:
English: These elevations were generally asymptomatic and returned to baseline after discontinuation of therapy or with continued treatment.
Danish: Disse stigninger var generelt symptomatiske og vendte tilbage til baseline efter seponering af behandlingen eller ved fortsat behandling.
English: Elderly patients No dose adjustment is required for elderly patients.
Danish: Ældre patienter Dosisjustering er ikke nødvendig hos ældre patienter.
English: • you are taking simvastatin (a statin) or a medicine containing simvastatin and are Chinese.
Danish: • De tager simvastatin (et statin) eller et lægemiddel, der indeholder simvastatin, og De er kineser.
English: Treatment with nicotinic acid reduces the risk of death and cardiovascular events, and slows progression or promotes regression of atherosclerotic lesions.
Danish: Behandling med nicotinsyre reducerer risikoen for død og kardiovaskulære hændelser og nedsætter progressionen eller fremmer regressionen af aterosklerotiske læsioner.
English: The safety of concomitant administration of nicotinic acid and laropiprant was assessed in dogs and rats.
Danish: Sikkerheden af samtidig administration af nicotinsyre og laropiprant blev vurderet hos hunde og rotter.
English: • yellowing of the skin and/or eyes (jaundice)
Danish: • Gulfarvning af hud og/eller øjne (gulsot)
English: The placebo-adjusted LDL-C, HDL-C and TG responses appeared greater among women compared to men and appeared greater among elderly patients (≥ 65 years) compared to younger patients (< 65 years).
Danish: Placebojusteret respons for LDL-C, HDL-C og TG forekom højere hos kvinder end hos mænd, og forekom højere hos ældre patienter (≥ 65 år) end hos yngre patienter (< 65 år).
English: If you get dizzy, you should avoid driving or operating machines after taking Pelzont.
Danish: Hvis De bliver svimmel, skal De undgå at køre bil eller betjene maskiner, efter De har taget Pelzont.
English: • Uncontrolled hypothyroidism
Danish: • Ukontrolleret hypothyroidisme.
English: In diabetic patients a median increase in HbA1c of 0.2 % was observed (where modification of hypoglycaemic therapy was allowed).
Danish: Hos diabetikere sås en gennemsnitlig stigning af HbA1c på 0,2 % (hvor modificering af hypoglykæmisk behandling var tilladt).
English: Patients who develop increased transaminase levels should be monitored until the abnormalities have resolved.
Danish: Patienter, som udvikler forhøjede transaminasekoncentrationer, bør monitoreres, indtil uregelmæssighederne er forsvundet.
English: The mechanisms by which nicotinic acid modifies the plasma lipid profile are not fully understood.
Danish: De mekanismer, hvorved nicotinsyre modificerer plasmalipidprofilen, er ikke fuldstændig forstået.
English: • you or close family members have a hereditary muscle disorder, or you have ever had muscle problems during treatment with cholesterol-lowering medicines called “statins” or fibrates.
Danish: • De selv eller et nært familiemedlem har en arvelig muskelsygdom, eller hvis De har haft muskelproblemer under behandling med kolesterolsænkende lægemidler såsom "statiner" eller fibrater.
English: Cases of overdose have been reported; the maximum dose of Pelzont taken was 5,000 mg/100 mg. All patients recovered without sequelae.
Danish: Der er rapporteret om tilfælde af overdosering; den højeste dosis, der var taget, var 5.000 mg/100 mg. Alle patienterne kom sig uden følgevirkninger.
English: • zidovudine, a medicine used for HIV.
Danish: • Zidovudin, medicin der bruges til hiv.
English: Nicotinic acid is less than 20 % bound to serum proteins.
Danish: Nicotinsyre er bundet mindre end 20 % til serumproteiner.
English: Ask your doctor or pharmacist for advice before taking this medicine.
Danish: Spørg Deres læge eller apoteket til råds, før De tager dette lægemiddel.
English: Laropiprant was not mutagenic or clastogenic in a series of genetic toxicology studies.
Danish: Laropiprant var ikke mutagent eller klastogent i en række af genetiske toksilogiundersøgelser.
English: Laropiprant and its acyl glucuronide conjugate are the major circulating components in human plasma.
Danish: Laropiprant og dets acylglucuronidkonjugat er de største cirkulerende komponenter i plasma hos mennesker.
English: Bioavailability with or without food is at least 72 % based on the recovery of the nicotinic acid dose in the urine.
Danish: Biotilgængeligheden med eller uden mad er mindst 72 % baseret på fundet af nicotinsyredosen i urinen.
English: Therefore, patients with a risk for hypophosphatemia should be closely followed.
Danish: Derfor bør patientermed risiko for at få hypofosfatæmi, følges tæt.
English: The frequencies of adverse reactions are ranked according to the following: Very common (≥ 1/10), 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), Not known (cannot be estimated from the available data).
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), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Laropiprant also has affinity for the thromboxane A2 receptor (TP) (although it is substantially less potent at TP as compared to DP1).
Danish: Laropiprant har også affinitet til tromboxane A2-receptoren (TP) (skønt den er væsentligt mindre potent ved TP sammenlignet med DP1).
English: • you have heart problems.
Danish: • De har hjerteproblemer.
English: If you stop taking Pelzont Do not stop taking Pelzont without talking to your doctor.
Danish: De må ikke holde op med at tage Pelzont uden at tale med lægen.
English: • If you take more than you should, talk to a doctor or pharmacist straight away.
Danish: • Hvis De har taget mere, end De skulle, skal De straks kontakte lægen eller apoteket.
English: ▲ Pelzont  nicotinic acid (laropiprant withdrawn at Week 21)
Danish: ▲ Pelzont  nicotinsyre (laropiprant seponeret ved uge 21)
English: • loss of control over urine and stool
Danish: • Manglende kontrol over urin og afføring
English: Average number of days per week with moderate or greater* flushing symptoms across weeks 1-24
Danish: Gennemsnitligt antal dage pr. uge med moderate eller mere udbredte* flushing-symptomer i ugerne 1-24
English: Diet and other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with Pelzont.
Danish: Diæt og anden ikke-farmakologisk behandling (f.eks. motion, vægtreduktion) bør fortsætte under behandlingen med Pelzont.
English: • low blood pressure
Danish: • Lavt blodtryk
English: • increased blood pressure
Danish: • Forhøjet blodtryk
English: The effect on lipids was similar whether Pelzont was given as monotherapy or was added to ongoing statin therapy with or without ezetimibe.
Danish: Indvirkningen på lipider var den samme, hvad enten Pelzont blev givet som monoterapi eller blev tilføjet til den igangværende statinbehandling med eller uden ezetimibe.
English: • skin disorder with dark velvety plaques called acanthosis nigricans
Danish: • Hudsygdom med mørke, fløjlsagtige pletter kaldet acanthosis nigricans
English: Therefore, laropiprant is not an inducer or inhibitor of CYP3A4.
Danish: Derfor er laropiprant ikke en inducer eller hæmmer af CYP3A4.
English: Therefore, Pelzont should not be used during pregnancy unless clearly necessary.
Danish: Pelzont bør derfor ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: It is unknown whether there is an increased risk of myopathy in other Asian patients treated with Pelzont co-administered with simvastatin or ezetimibe/simvastatin.
Danish: Det vides ikke, om der er en øget risiko for myopati hos andre asiatiske patienter, som behandles med Pelzont samtidigt med simvastatin eller ezetimibe/simvastatin.
English: When Pelzont is co-administered with a statin, please refer to the Summary of Product Characteristics for that particular medicinal product.
Danish: Når Pelzont gives samtidigt med et statin henvises til produktresuméet for dette specifikke lægemiddel.
English: • clopidogrel and acetylsalicylic acid (ASA), medicines to help prevent harmful blood clots.
Danish: • Clopidogrel og acetylsalicylsyre (ASA), medicin som forebygger blodpropper.
English: Therefore, Pelzont should not be used in children and adolescents under 18 years of age.
Danish: Derfor må Pelzont ikke anvendes til børn og teenagere under 18 år.
English: Acetylsalicylic acid provides no additional reduction of flushing beyond that achieved by Pelzont.
Danish: Acetylsalicylsyre giver ikke yderligere reduktion af flushing, ud over den der opnås ved Pelzont.
English: In clinical trials, over 5,700 patients received Pelzont alone or with an HMG-CoA reductase inhibitor.
Danish: I kliniske undersøgelser har mere end 5.700 patienter fået Pelzont alene eller sammen med en HMGCoA-reduktasehæmmer.
English: Flushing is the most common adverse reaction of Pelzont.
Danish: Flushing er den mest almindelige bivirkning ved Pelzont.
English: Over time, this plaque build-up can lead to a clogging of your arteries.
Danish: Med tiden kan denne ophobning af plak føre til tilstopning af blodårerne.
English: Genetic and pharmacologic studies in animal models have provided evidence that PGD2, acting through DP1, one of the two receptors for PGD2, plays a key role in nicotinic acid-induced flushing.
Danish: Genetiske og farmakologiske undersøgelser med dyremodeller har vist tegn på, at PGD2, der virker gennem DP1, en af de to receptorer for PGD2, spiller en vigtig rolle i nicotinsyreinduceret flushing.
English: • Arterial bleeding.
Danish: • Arteriel blødning.
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst the medicinal product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at det lægemiddelovervågningssystem, som er beskrevet i modul 1.8.1 i markedsføringstilladelsen, er på plads og fungerer, før og under markedsføringen af lægemidlet.
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure, indicating little relevance to human use.
Danish: I prækliniske undersøgelser sås kun effekt ved eksponeringer, der blev anset for at være tilstrækkeligt over den maksimale eksponering for mennesker, hvilket tyder på ringe relevans for brugen til mennesker.
English: INFORMATION IN BRAILLE Pelzont
Danish: INFORMATION I BRAILLESKRIFT Pelzont
English: • to raise levels of ‘good' cholesterol (HDL cholesterol) and apo A-I (a part of HDL).
Danish: • øge mængden af det "gode" kolesterol (HDL-kolesterol) og apo-A-I (en del af HDL).
English: Therefore, patients undergoing surgery should be carefully evaluated.
Danish: Patienter, der skal have foretaget en operation, bør derfor vurderes nøje.
English: During controlled clinical trials in healthy subjects, single doses of up to 900 mg laropiprant and multiple doses up to 450 mg once daily for 10 days were generally well tolerated.
Danish: I kontrollerede kliniske undersøgelser med raske forsøgspersoner var enkeltdoser af op til 900 mg laropiprant og multiple doser op til 450 mg én gang dagligt i 10 dage generelt veltålt.
English: Mice in this study received approximately 9 to 13 times a human nicotinic acid dose of 2,000 mg/day as determined on a mg/m2 basis.
Danish: Mus i denne undersøgelse fik ca. 9-13 gange en human nicotinsyredosis på 2.000 mg/dag fastlagt på basis af mg/m2.
English: If Pelzont is missed for less than 7 consecutive days, patients can resume therapy at the last administered dose.
Danish: Hvis patienten har undladt at tage Pelzont i færre end 7 på hinanden følgende dage, kan behandlingen genoptages ved den senest administrerede dosis.
English: • Your doctor may also want you to periodically have blood tests after you start taking Pelzont, to check how well your liver is working and for other side effects.
Danish: • Lægen vil måske også tage blodprøver af og til, efter De er begyndt at tage Pelzont for at kontrollere, hvor godt Deres lever virker, og om der er andre bivirkninger.
English: • burning sensation
Danish: • Brændende fornemmelse
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP. Do not store above 30°C.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakning og blister efter EXP.
English: • swelling of the fingers, toes or ankles
Danish: • Hævede fingre, tæer eller ankler
English: Patients receiving Pelzont concomitantly with acetylsalicylic acid and clopidogrel should be closely monitored as recommended in the Summary of Product Characteristics for those medicinal products and should be told that it might take longer than usual to stop bleeding and that they should report any unusual bleeding (site or duration) to their physician.
Danish: Patienter, der får Pelzont sammen med acetylsalicylsyre og clopidogrel, bør monitoreres tæt som anbefalet i produktresuméet for disse lægemidler, og skal informeres om, at det kan tage længere tid end normalt at stoppe en blødning, og at de skal indberette al unormal blødning (sted eller varighed) til lægen.
English: • you have unexplained muscle pain, muscle tenderness, or muscle weakness.
Danish: • De har uforklarlige muskelsmerter, muskelømhed eller muskelsvaghed.
English: If muscle pain, weakness or cramps occur while a patient is receiving Pelzont with a statin, their CK levels should be measured.
Danish: Hvis muskelsmerter, -svaghed eller -kramper opstår, mens patienten er i behandling med Pelzont sammen med et statin, skal CK-koncentrationerne måles.
English: The Coronary Drug Project, a five year study completed in 1975, showed that nicotinic acid had a statistically significant benefit in decreasing nonfatal, recurrent myocardial infarctions (MI) in men 30 to 64 years old with a history of MI.
Danish: Coronary Drug Project, en fem-årig undersøgelse, der afsluttedes i 1975, viste, at nicotinsyre havde en statistisk signifikant positiv indvirkning på reduktionen af nonfatale, tilbagevendende myokardieinfarkter (MI) hos mænd i alderen 30-64 år med MI i anamnesen.
English: • After 4 weeks, your doctor may raise your dose to two tablets a day.
Danish: • Efter 4 uger kan lægen øge dosis til to tabletter om dagen.
English: In vitro studies have shown that the acyl glucuronide conjugate of laropiprant had at least a 65-fold reduced affinity for DP1 as compared to laropiprant; thus, it is not expected to contribute to the overall DP1 activity of laropiprant.
Danish: In vitroundersøgelser har vist, at laropiprants acylglucuronidkonjugat havde mindst 65 gange reduceret affinitet til DP1 i sammenligning med laropiprant; dette forventes derfor ikke at bidrage til laropiprants totale DP1-aktivitet.
English: • vitamins or supplements that contain nicotinic acid.
Danish: • Vitaminer eller kosttilskud, som indeholder nicotinsyre.
English: Physicians contemplating combined therapy with statins and Pelzont should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs and symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and when the dose of either medicinal product is increased.
Danish: Læger, som overvejer kombinationsbehandling med statiner og Pelzont, bør nøje overveje de mulige fordele i forhold til risikoen og bør monitorere patienterne nøje med henblik på tegn og symptomer på muskelsmerte, -ømhed eller -svaghed, især i de første måneder af behandlingen, og når doseringen af et af lægemidlerne øges.
English: Ketonuria and hepatocellular centrilobular hypertrophy were observed in rats in repeated dose toxicity studies for up to 6 months dosing.
Danish: Ketonuri og hepatocellulær centrilobulær hypertrofi sås hos rotter i gentagne dosistoksicitetsundersøgelser med op til 6 måneders dosering.
English: • The active substances are nicotinic acid and laropiprant.
Danish: • Aktive stoffer: Nicotinsyre og laropiprant.
English: Other medicinal products: Co-administration of laropiprant 40 mg with midazolam increased the AUC0-∞ and Cmax of 1'-hydroxymidazolam, a midazolam metabolite, by 98 % and 59 %, respectively.
Danish: Andre lægemidler: Samtidig administration af laropiprant 40 mg og midazolam øgede AUC0-∞ og Cmax for 1'-hydroxymidazolam, en midazolammetabolit, med henholdsvis 98 % og 59 %.
English: Pelzont was consistently efficacious across all prespecified patient subpopulations defined by race, gender, baseline LDL-C, HDL-C and TG levels, age and diabetes status.
Danish: Pelzont var konsekvent effektivt på tværs af alle på forhånd specificerede patientundergrupper i henhold til race, køn, LDL-C, HDL-C og TG ved baseline, alder og diabetesstatus.
English: If these levels are found, in the absence of strenuous exercise, to be significantly elevated (> 5 x ULN), treatment should be stopped.
Danish: Hvis disse koncentrationer viser sig at være signifikant forhøjede (>5 x ULN), uden forudgående hård motion, bør behandlingen stoppes.
English: Effect on lipids
Danish: Indvirkning på lipider
English: Based on these data, laropiprant is not expected to cause interactions with substrates of CYP isozymes 3A4, 2C9, 2C8 and human P-glycoprotein (P-gp).
Danish: På basis af disse data forventes laropiprant ikke at medføre interaktion med substrater af CYP-isozymerne 3A4, 2C9, 2C8 og humant P-glycoprotein (P-gp).
English: • Active peptic ulcer disease.
Danish: • Aktivt ulcus pepticum.
English: Not known: frequency cannot be estimated from the available data Additionally, the following were reported during post-marketing experience with Pelzont and/or other nicotinic acid products (alone and/or with certain other cholesterol-lowering medicines).
Danish: Ikke kendt: hyppigheden kan ikke vurderes ud fra tilgængelige data Desuden er følgende bivirkninger blevet rapporteret efter markedsføring af Pelzont og/eller andre nicotinsyrepræparater (alene og/eller sammen med visse andre kolesterolsænkende lægemidler):
English: • swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing (angioedema, which may require treatment right away)
Danish: • Hævelse af ansigt, læber, tunge og/eller svælg som kan medføre besvær med at trække vejret eller synke (angioødem som kan kræve omgående behandling)
English: Transaminase elevations were reversible upon discontinuation of therapy.
Danish: Transaminaseforhøjelser var reversible ved seponering af behandlingen.
English: The rate and extent of absorption are not altered with a high-fat meal.
Danish: Absorptionshastigheden og -graden ændredes ikke ved et måltid med højt fedtindhold.
English: Drinking alcohol or hot drinks or eating spicy foods can enhance the effects of flushing and should therefore be avoided around the time of ingestion of Pelzont.
Danish: Indtagelse af alkohol eller varme drikke eller krydret mad kan forstærke flushing-effekten og bør derfor undgås omkring tidspunktet for indtagelse af Pelzont.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Hvis De af Deres læge har fået at vide, at der er visse sukkestoffer, De ikke kan tåle, skal De kontakte lægen, før De tager denne medicin.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy should be made taking into account the benefit of breast-feeding to the child and the benefit of Pelzont to the woman.
Danish: Beslutning om, hvorvidt amningen eller behandlingen skal fortsætte/ophøre, bør tages i forhold til den gavnlige virkning af amning for barnet og den gavnlige virkning af Pelzont for kvinden.