FrancophonIA/ELRC3.0 huggingface dataset:
English: The major component (73 % of radioactivity) in faeces is laropiprant (comprising unabsorbed active substance and/or hydrolysed glucuronic acid conjugate).
Danish: Den største komponent (73 % af radioaktiviteten) i fæces er laropiprant (bestående af uabsorberet aktiv substans og/eller hydrolyseret glucuronidsyrekonjugat).
English: In a pool of four active- or placebo-controlled clinical trials (N=4,747, n=2,548 taking Pelzont), flushing was reported in 12.3 % of patients taking Pelzont.
Danish: I fire aktive eller placebo-kontrollerede kliniske undersøgelser (N=4.747, n=2.548, der tog Pelzont) blev der rapporteret om flushing hos 12,3 % af de patienter, der fik Pelzont.
English: The following adverse reactions have been reported during clinical studies and/or post-marketing use with Pelzont (with or without a statin).
Danish: Følgende bivirkninger er rapporteret under de kliniske studier og/eller ved brug af Pelzont efter markedsføring (med eller uden et statin).
English: Clinical and in vitro studies support the conclusion that laropiprant is a mild to moderate inhibitor of UGT2B4/UGT2B7.
Danish: Kliniske og in vitro-undersøgelser understøtter den konklusion, at laropiprant er en mild til moderat hæmmer af UGT2B4/UGT2B7.
English: At higher doses or higher rates of absorption, the NAD pathway is saturable, and an increasing fraction of the oral dose reaches the bloodstream unchanged as nicotinic acid.
Danish: Ved højere doser eller højere absorptionshastigheder er NAD-vejen mættet, og en stigende fraktion af den perorale dosis når blodbanen uændret som nicotinsyre.
English: The incidence and frequency of moderate or greater flushing in patients treated with Pelzont for the duration of the study decreased.
Danish: Incidensen og hyppigheden af moderat og mere udbredt flushing hos patienter, der fik Pelzont i hele studiets varighed, faldt.
English: In order for your medicine to work as intended, do not split, break, crush, or chew the tablet before you swallow it.
Danish: For at Deres medicin skal virke efter hensigten, må De ikke dele, bryde, knuse eller tygge tabletten, før De sluger den.
English: Nicotinic acid causes a relative shift in the distribution of LDL subclasses from small, dense (most atherogenic) LDL particles to larger LDL particles.
Danish: Nicotinsyre forårsager en relativ forandring i fordelingen af LDL-undergrupperne fra små, tætte (mest aterogene) LDL-partikler til større LDL-partikler.
English: Effects of other medicinal products on laropiprant
Danish: Andre lægemidlers indvirkning på laropiprant
English: Pelzont should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease.
Danish: Pelzont bør anvendes med forsigtighed hos patienter, som indtager væsentlige mængder alkohol og/eller har leversygdom i anamnesen.
English: The pharmacokinetic interaction of Pelzont with statins has been studied only with simvastatin (see section 4.4).
Danish: Pelzonts farmakokinetiske interaktion med statiner er kun blevet undersøgt for simvastatin (se pkt.
English: Pharmacotherapeutic group: Lipid modifying agents, nicotinic acid and derivatives, ATC code: C10AD52.
Danish: Farmakoterapeutisk klassifikation: Lipidmodificerende midler, nicotinsyre og derivater, ATC-kode: C10AD52.
English: Nicotinic acid undergoes extensive first-pass metabolism through two pathways that are dose and dose-rate dependent.
Danish: Nicotinsyre gennemgår ekstensiv first-pass-metabolisme ad to veje, som er afhængig af dosis og dosishastighed.
English: In urine, the primary component is the acyl glucuronide conjugate (64 % of radioactivity) with smaller contributions from the parent compound (5 %).
Danish: I urinen er den primære komponent acylglucuronidkonjugatet (64 % af radioaktiviten) med mindre bidrag fra stamproduktet (5 %).
English: As with other nicotinic acid medicinal products, caution should be used when Pelzont is used in patients with unstable angina or in the acute phase of an MI, particularly when such patients are also receiving vasoactive medicinal products such as nitrates, calcium channel blockers, or adrenergic blocking agents.
Danish: Som med andre nicotinsyrepræparater bør der udvises forsigtighed, når Pelzont anvendes til patienter med ustabil angina eller patienter i den akutte fase af myokardieinfarkt, især når disse patienter også får vasoaktive lægemidler, såsom nitrater, calciumkanalblokkere eller adrenerge blokkere.
English: Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom
Danish: Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon Hertfordshire EN11 9BU Storbritannien
English: With low doses of nicotinic acid or lower rates of absorption, the first pathway predominates.
Danish: Ved lave doser af nicotinsyre eller lavere absorptionshastighed er den første metaboliseringsvej dominerende.
English: • Taking aspirin before you take Pelzont does not reduce your flushing more than taking Pelzont alone.
Danish: • At tage acetylsalicylsyre før De tager Pelzont vil ikke mindske Deres rødmen mere, end hvis De tager Pelzont alene.
English: In interaction studies, laropiprant did not have clinically significant effects on the pharmacokinetics of the following medicinal products: simvastatin, warfarin, oral contraceptives, rosiglitazone and digoxin.
Danish: I interaktionsundersøgelser havde laropiprant ingen klinisk signifikant indvirkning på farmakokinetikken af følgende lægemidler: Simvastatin, warfarin, perorale kontraceptiva, rosiglitazon og digoxin.
English: The medicine comes as a modified-release tablet.
Danish: Medicinen fås som en tablet med modificeret udløsning.
English: • rash with flat, red spots
Danish: • Udslæt med flade, røde pletter
English: Animal studies have shown excretion of laropiprant in milk.
Danish: Dyreforsøg har vist udskillelse af laropiprant i mælken.
English: Pelzont contains nicotinic acid, which at therapeutic doses is a lipid-modifying agent, and laropiprant, a potent, selective antagonist of the prostaglandin D2 (PGD2) receptor subtype 1 (DP1).
Danish: Pelzont indeholder nicotinsyre, som i terapeutiske doser er et lipidmodificerende stof, og laropiprant, der er en potent, selektiv prostaglandin D2-antagonist (PGD2) receptorsubtype 1 (DP1).
English: Primary means that the hypercholesterolaemia does not have any identifiable cause.
Danish: Primær betyder, at årsagen til hyperkolesterolæmien ikke er kendt.
English: Your total cholesterol is made up mainly of ‘bad' (LDL) and ‘good' (HDL) cholesterol.
Danish: Totalt kolesterol består hovedsageligt af "dårligt" (LDL) og "godt" (HDL) kolesterol.
English: The reduction in flushing symptoms (assessed by patient questionnaires) was correlated with a reduction in nicotinic acid-induced vasodilatation (assessed by measurements of skin blood flow).
Danish: Reduktionen af flushing-symptomer (vurderet ved hjælp af patientspørgeskemaer) blev korreleret med en reduktion i nicotinsyreinduceret vasodilatation (vurderet ved hjælp af målinger af blodgennemstrømningen i huden).
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Danish: Indehaveren af markedsføringstilladelsen skal udføre de lægemiddelovervågningsaktiviteter, som er beskrevet i lægemiddelovervågningsplanen (ifølge aftalen i RMP modul 1.8.2 i markedsføringstilladelsen), og enhver efterfølgende opdatering af RMP, som er godkendt af Udvalget for Lægemidler til Mennesker (CHMP).
English: To preserve the modified-release properties, the tablets must not be split, broken, crushed, or chewed before swallowing.
Danish: For at bevare egenskaberne ved den modificerede udløsning, må tabletterne ikke deles, brydes, knuses eller tygges, før de sluges.
English: • medicines used to lower cholesterol called ‘statins'.
Danish: • Medicin til at sænke kolesterol kaldet "statiner".
English: Midazolam: Multiple doses of laropiprant 40 mg did not affect the pharmacokinetics of midazolam, a sensitive CYP3A4 substrate.
Danish: Midazolam: Flergangsdosering med laropiprant 40 mg påvirkede ikke midazolams farmakokinetik, der er et sensitivt CYP3A4-substrat.
English: Women have a modest increase in plasma concentrations of nicotinuric acid and nicotinic acid compared to men.
Danish: Kvinder har en beskeden stigning i nicotinurinsyres og nicotinsyres plasmakoncentration sammenlignet med mænd.
English: However, if you do not take Pelzont for 7 or more days in a row, talk to your doctor before restarting Pelzont.
Danish: Men hvis De ikke har taget Pelzont i 7 dage eller mere i træk, skal De tale med lægen, før De igen begynder at tage Pelzont.
English: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Danish: Fortæl altid lægen eller på apoteket, hvis De bruger anden medicin eller har gjort det for nylig.
English: Because 1'-hydroxymidazolam is an active metabolite, the sedative effect of midazolam may be increased and caution should be used when laropiprant is co-administered with midazolam.
Danish: Da l'-hydroxymidazolam er en aktiv metabolit, kan midazolams sedative virkning øges, og forsigtighed bør udvises, når laropiprant gives samtidigt med midazolam.
English: This effect is unlikely to be clinically important as laropiprant did not increase bleeding time when co-administered with clopidogrel throughout the dosing interval.
Danish: Denne effekt forventes ikke at have klinisk betydning, da laropiprant ikke øgede blødningstiden, når det blev administreret sammen med clopidogrel i hele doseringsintervallet.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Patienter med arvelig galactoseintolerans, en særlig form for arvelig lactasemangel (Lapp Lactase deficiency) eller glucose/-galactosemalabsorption bør ikke tage dette lægemiddel.
English: Pelzont has not been studied in children and adolescents who are under 18 years of age.
Danish: Pelzont er ikke undersøgt hos børn og unge under 18 år.
English: Pelzont is not recommended in pregnancy unless clearly necessary.
Danish: Pelzont må ikke anvendes under graviditet, med mindre det er klart nødvendigt.
English: • Swallow each tablet whole.
Danish: • Slug tabletten hel.
English: In humans, nicotinamide is further predominantly metabolised to N-methylnicotinamide (MNA) and to N-methyl-2-pyridone-5-carboxamide (2PY).
Danish: Hos mennesker metaboliseres nicotinamid desuden overvejende til Nmethylnicotinamid (MNA) og til N-methyl-2-pyridon-5-carboxamid (2PY).
English: The glycine conjugation pathway is not saturated across the clinically relevant dose range, based on the dose-proportional increase in the plasma concentrations of NUA from 1,000 mg to 2,000 mg.
Danish: Metaboliseringsvejen, hvor glycin konjugeres, mættes ikke gennem det klinisk relevante dosisområde på basis af den dosisproportionale stigning i plasmakoncentrationen af NUA fra 1.000-2.000 mg.
English: Because nicotinic acid and its metabolites are excreted through the kidneys, Pelzont should be used with caution in patients with renal dysfunction.
Danish: Da nicotinsyre og dets metabolitter udskilles via nyrerne, bør Pelzont anvendes med forsigtighed hos patienter med nyreinsufficiens.
English: Primary hypercholesterolaemia is when the levels of cholesterol in the blood are high.
Danish: Ved primær hyperkolesterolæmi er indholdet af kolesterol i blodet højt.
English: Laropiprant: Consistent with the characteristics of a medicinal product that is primarily cleared by metabolism, moderate hepatic disease has a significant impact on laropiprant pharmacokinetics, with an increase in AUC and Cmax of approximately 2.8- and 2.2-fold respectively.
Danish: Laropiprant: I overensstemmelse med karakteristika for et lægemiddel, der primært elimineres via metabolisme, har moderat leversygdom signifikant indvirkning på laropiprants farmakokinetik med en stigning i AUC og Cmax på henholdsvis ca. 2,8 og 2,2 gange.
English: The oxidative metabolism of laropiprant is catalysed primarily by CYP3A4, whereas several UGT isoforms (1A1, 1A3, 1A9 and 2B7) catalysed the acyl glucuronidation.
Danish: Laropiprants oxidative metabolisme katalyseres primært af CYP3A4, mens mange UGT-isoformer (1A1, 1A3, 1A9 og 2B7) katalyserede acylglucuronideringerne.
English: • When new information is received that may impact on the current Safety Specification,
Danish: • når der modtages nye oplysninger, der kan have indflydelse på den gældende sikkerhedsspecifikation, lægemiddelovervågningsplan eller på risikominimeringsaktiviteter
English: Laropiprant has been shown to be effective in reducing flushing symptoms induced by nicotinic acid.
Danish: Laropiprant har vist sig at være effektiv til at reducere flushing-symptomer, der er induceret af nicotinsyre.
English: Nicotinic acid is predominantly excreted in the urine as metabolites.
Danish: Nicotinsyre udskilles overvejende i urinen som metabolitter.
English: The pharmacokinetics of laropiprant are linear, displaying approximately dose-proportional increases in AUC and Cmax and no evidence of time-dependent clearance.
Danish: Laropiprants farmakokinetik er lineær og udviser omtrentlige dosisproportionale stigninger i AUC og Cmax og ingen tegn på tidsafhængig clearance.
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 tilstoppe blodårerne, og fordi det beskytter mod hjertesygdom.
English: HDL is hypothesised to participate in the transport of cholesterol from tissues back to the liver, to suppress vascular inflammation associated with atherosclerosis, and to have anti-oxidative and anti-thrombotic effects.
Danish: Det antages, at HDL deltager i transporten af kolesterol fra vævene tilbage til leveren for at hæmme vaskulær inflammation, der er forbundet med aterosklerose, og for at have antioxidativ og antitrombotisk effekt.
English: Nicotinic acid showed no mutagenic effects in the in vitro assays.
Danish: Nicotinsyre viste ingen mutagen effekt i in vitro-assays.
English: Nicotinic acid-induced flushing is mediated primarily by release of prostaglandin D2 (PGD2) in the skin.
Danish: Nicotinsyreinduceret flushing er primært medieret ved frigørelse af prostaglandin D2 (PGD2) i huden.
English: Medicinal product /laboratory test interactions: In urine glucose tests, nicotinic acid may also give false-positive reactions with cupric sulfate solution (Benedict's reagent).
Danish: Lægemiddel-/laboratorietest-interaktioner: I uringlucoseprøver kan nicotinsyre også give falsk positive reaktioner med opløsning af kobbersulfat (Benedicts prøve).
English: Laropiprant has no effect on lipid levels nor does it interfere with the effects of nicotinic acid on lipids.
Danish: Laropiprant har ingen effekt på lipidniveauerne og interfererer ikke med nicotinsyres indvirkning på lipider.
English: Therefore, taking aspirin to reduce flushing symptoms is not necessary.
Danish: Det er derfor ikke nødvendigt at tage aspirin for at mindske symptomerne på rødmen.
English: • palpitation (feeling your heartbeat)
Danish: • Hjertebanken (man mærker sit hjerteslag)
English: Capsule-shaped, white to off-white tablet, with “552” debossed on one side.
Danish: Kapselformet, hvid/off-white tablet mærket med "552" på den ene side.
English: After 4 weeks, your doctor may raise your dose of Pelzont to two tablets a day.
Danish: Efter 4 uger vil lægen måske hæve dosis til to tabletter om dagen.
English: If you forget to take Pelzont
Danish: Hvis De har glemt at tage Pelzont
English: Nicotinic acid also elevates the HDL2 subfraction to a greater extent than the HDL3 subfraction, thereby increasing the HDL2:HDL3 ratio, which is associated with decreased cardiovascular disease risk.
Danish: Nicotinsyre øger også HDL2-subfraktionen i højere grad end HDL3-subfraktionen og øger dermed HDL2:HDL3-ratioen, som er forbundet med nedsat kardiovalsulær risiko.
English: The mean volume of distribution at steady state following a single 40 mg intravenous dose of laropiprant to healthy subjects is approximately 70 litres.
Danish: Gennemsnitlig distributionsvolumen ved steady state efter en enkelt 40 mg intravenøs dosis af laropiprant til raske forsøgspersoner er ca. 70 liter.
English: Therefore, treatment with acetylsalicylic acid to alleviate flushing symptoms is not necessary (see section 5.1).
Danish: Behandling med acetylsalicylsyre til at mildne symptomerne på flushing er ikke nødvendig (se pkt.
English: Additional explanations that do not invoke plasma FFA reduction as the central driver of lipid profile modification include nicotinic acid-mediated inhibition of de novo lipogenesis or esterification of fatty acids into TG in the liver.
Danish: Andre forklaringer, som ikke udnævner plasma FFAreduktioner som central drivkraft for modificering af lipidprofilen, omfatter nicotinsyremedieret hæmning af de novo-lipogenese eller esterificering af fedtsyrer til TG i leveren.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE
English: • to lower your ‘bad' cholesterol level.
Danish: • sænke det "dårlige" kolesterol.
English: Nicotinic acid For an overdose of nicotinic acid, supportive measures should be employed.
Danish: Nicotinsyre Ved overdosering af nicotinsyre bør understøttende forholdsregler anvendes.
English: Laropiprant is not a substrate of human P-gp, and therefore other inhibitors of CYP3A4 and/or P-gp are also not expected to have a clinically meaningful impact on the pharmacokinetics of laropiprant.
Danish: Laropiprant er ikke et substrat af humant P-gp, og derfor forventes andre hæmmere af CYP3A4 og/eller P-gp heller ikke at have en klinisk relevant indvirkning på laropiprants farmakokinetik.
English: • Significant or unexplained hepatic dysfunction.
Danish: • Signifikant eller uforklarlig leverinsufficiens.
English: Pharmacokinetic steady state is achieved within 2 days of once-daily dosing of laropiprant, with minimal accumulation in AUC (approximately 1.3-fold) and Cmax (approximately 1.1-fold).
Danish: Farmakokinetisk steady state opnåedes inden for 2 dage efter dosering én gang dagligt af laropiprant med minimal akkumulation i AUC (ca. 1,3 gange) og Cmax (ca. 1,1 gange).
English: • rapid or irregular heartbeat
Danish: • Hurtig eller uregelmæssig hjerterytme (puls)
English: What you need to know before you take Pelzont
Danish: Det skal De vide, før De begynder at tage Pelzont
English: Pelzont is indicated for the treatment of dyslipidaemia, particularly in adult patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL-cholesterol and triglycerides and low HDL-cholesterol) and in adult patients with primary hypercholesterolaemia (heterozygous familial and non-familial).
Danish: Pelzont er indiceret til behandling af dyslipidæmi, især hos voksne patienter med kombineret dyslipidæmi (karakteriseret ved forhøjede koncentrationer af LDL-kolesterol og triglycerider samt lavt HDL-kolesterol) og hos voksne patienter med primær hyperkolesterolæmi (heterozygot familiær og non-familiær).
English: Paediatric population Pelzont: No studies have been performed in paediatric patients.
Danish: Pædiatrisk population Pelzont: Der er ikke udført undersøgelser med børn.
English: Supplements containing nicotinic acid: Vitamins or other nutritional supplements containing (≥ 50 mg/day) of nicotinic acid (or nicotinamide) have not been studied with Pelzont.
Danish: Kosttilskud med nicotinsyre: Vitaminer eller andre ernæringstilskud med (≥ 50 mg /dag) nicotinsyre (eller nicotinamid) er ikke blevet undersøgt sammen med Pelzont.
English: Patients with hepatic or renal insufficiency
Danish: Patienter med lever- eller nyreinsufficiens
English: Switching from immediate-release (crystalline) nicotinic acid to Pelzont has not been studied.
Danish: Skift fra nicotinsyre med umiddelbar udløsning (krystallinsk) til Pelzont er ikke undersøgt.
English: In these studies, the percentage of patients taking Pelzont, nicotinic acid (pooled prolonged-release formulations) or pooled placebo/simvastatin who discontinued due to any flushing-related symptom (redness, warmth, itching and tingling) was 7.2 %, 16.6 %, and 0.4 %, respectively.
Danish: I disse undersøgelser var procentdelen af patienter, der fik Pelzont, nicotinsyre (depotformuleringer, poolede) eller placebo/simvastatin (poolet), og som stoppede behandlingen på grund af flushing-relaterede symptomer (rødme, varme, kløe og prikken i huden) henholdsvis 7,2 %, 16,6 % og 0,4 %.
English: • Previous history of muscular toxicity with a statin or fibrate
Danish: • Muskulær toksicitet i anamnesen med statin eller fibrat.
English: *Includes patients with moderate, severe, or extreme flushing symptoms †Dose advancement at Week 5
Danish: *Inkluderer patienter med moderate, svære eller ekstreme flushing-symptomer
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE CARTON Multi-packs of 196 (2 packs of 98 modified-release tablets) - without blue box (for PVC/Aclar blister)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN MELLEMSTE EMBALLAGE Multipakninger à 196 (2 pakninger à 98 tabletter med modificeret udløsning) - uden blå boks (til PVC/Aclar blister)
English: Like LDL, cholesterol-enriched triglyceride-rich lipoproteins, including VLDL, intermediate-density lipoproteins (IDL), and remnants, can also promote atherosclerosis.
Danish: På samme måde som LDL kan også kolesterol- og triglyceridholdige lipoproteiner, inklusive VLDL, intermediate-density lipoproteins (IDL) og rester, fremme aterosklerose.
English: 1'-hydroxymidazolam is metabolised predominantly by uridine diphosphate-glucuronosyltransferases (UGT) 2B4 and 2B7.
Danish: 1'hydroxymidazolam metaboliseres overvejende af uridindiphosphat glucuronosyltransferaserne (UGT) 2B4 og 2B7.
English: In three large clinical trials measuring patient-reported flushing symptoms, patients taking Pelzont experienced less flushing than those taking nicotinic acid (prolonged-release formulations).
Danish: I tre store kliniske undersøgelser, hvor patientrapporterede flushing-symptomer blev målt, oplevede de patienter, der tog Pelzont, mindre flushing end de patienter, der tog nicotinsyre (depotformuleringer).
English: In the second study (16 weeks) where acetylsalicylic acid was allowed, patients taking Pelzont experienced significantly fewer days per week with moderate or greater flushing compared to nicotinic acid (prolonged-release formulation taken as a 12-week multi-step 500 mg to 2,000 mg titration) (p< 0.001).
Danish: I den anden undersøgelse (16 uger), hvor acetylsalicylsyre var tilladt, oplevede de patienter, der fik Pelzont, signifikant færre dage pr. uge med moderat eller mere udbredt flushing sammenlignet med nicotinsyre (taget som depotformulering med multi-step titrering fra 500 mg til 2.000 mg over 12 uger) (p < 0,001).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (for PVC/Aclar blister)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON (til PVC/Aclar blister)
English: Cholesterol is one of several fats found in your blood.
Danish: Kolesterol er et af flere fedtstoffer i blodet.