FrancophonIA/ELRC3.0 huggingface dataset:
English: Tredaptive has not been studied in children and adolescents who are under 18 years of age.
Danish: Tredaptive er ikke undersøgt hos børn og unge under 18 år.
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 Tredaptive.
Danish: Indtagelse af alkohol eller varme drikke eller krydret mad kan forstærke flushing-effekten og bør derfor undgås omkring tidspunktet for indtagelse af Tredaptive.
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 Tredaptive 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 Tredaptive for kvinden.
English: The pharmacokinetic interaction of Tredaptive with statins has been studied only with simvastatin (see section 4.4).
Danish: Tredaptives farmakokinetiske interaktion med statiner er kun blevet undersøgt for simvastatin (se pkt.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Danish: Yderligere information om Tredaptive findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
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: Tredaptive 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: Tredaptive 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: • Taking aspirin before you take Tredaptive does not reduce your flushing more than taking Tredaptive alone.
Danish: • At tage acetylsalicylsyre før De tager Tredaptive vil ikke mindske Deres rødmen mere, end hvis De tager Tredaptive alene.
English: The following adverse reactions have been reported during clinical studies and/or post-marketing use with Tredaptive (with or without a statin).
Danish: Følgende bivirkninger er rapporteret under de kliniske studier og/eller ved brug af Tredaptive efter markedsføring (med eller uden et statin).
English: As with other nicotinic acid medicinal products, caution should be used when Tredaptive 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 Tredaptive 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: Tredaptive should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease.
Danish: Tredaptive bør anvendes med forsigtighed hos patienter, som indtager væsentlige mængder alkohol og/eller har leversygdom i anamnesen.
English: MSD Italia S.r.l.
Danish: MSD ItaliaS.r.l.
English: Because nicotinic acid and its metabolites are excreted through the kidneys, Tredaptive should be used with caution in patients with renal dysfunction.
Danish: Da nicotinsyre og dets metabolitter udskilles via nyrerne, bør Tredaptive anvendes med forsigtighed hos patienter med nyreinsufficiens.
English: Should an increase in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of ≥ 3 X ULN persist, reduction of dose or withdrawal of Tredaptive is recommended.
Danish: Hvis en forhøjelse i alaninaminotransferase (ALAT) eller aspartataminotransferase (ASAT) af ≥ 3 x ULN (øvre normalgrænse) varer ved, bør Tredaptive reduceres eller seponeres.
English: In these studies, the percentage of patients taking Tredaptive, 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 Tredaptive, 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: It can be used as monotherapy only in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated.
Danish: Tredaptive kan anvendes som monoterapi hos patienter, hvor HMG-CoA-reduktasehæmmere anses for at være uhensigstmæssige eller ikke tåles.
English: Tredaptive 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: Tredaptive 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: What you need to know before you take Tredaptive
Danish: Det skal De vide, før De begynder at tage Tredaptive
English: Supplements containing nicotinic acid: Vitamins or other nutritional supplements containing (≥ 50 mg/day) of nicotinic acid (or nicotinamide) have not been studied with Tredaptive.
Danish: Kosttilskud med nicotinsyre: Vitaminer eller andre ernæringstilskud med (≥ 50 mg /dag) nicotinsyre (eller nicotinamid) er ikke blevet undersøgt sammen med Tredaptive.
English: Tredaptive contains a sugar called lactose.
Danish: Tredaptive indeholder et sukkerstof, der kaldes lactose.
English: In three large clinical trials measuring patient-reported flushing symptoms, patients taking Tredaptive 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 Tredaptive, mindre flushing end de patienter, der tog nicotinsyre (depotformuleringer).
English: Switching from immediate-release (crystalline) nicotinic acid to Tredaptive has not been studied.
Danish: Skift fra nicotinsyre med umiddelbar udløsning (krystallinsk) til Tredaptive er ikke undersøgt.
English: Physicians should consider the nicotinic acid intake from vitamins and nutritional supplements when prescribing Tredaptive.
Danish: Lægen bør overveje indtaget af nicotinsyre fra vitaminer og enæringstilskud, når Tredaptive ordineres.
English: In controlled clinical studies, the incidence of clinically important elevations in serum transaminases (ALT and/or AST ≥ 3 X ULN, consecutive) was 1.0 % for patients treated with Tredaptive with or without a statin.
Danish: I kontrollerede kliniske undersøgelser var incidensen af klinisk relevante stigninger i serumtransaminaser (ALAT og/eller ASAT ≥ 3 x ULN (øvre normalgrænse) konsekutivt) 1,0 % for patienter, der blev behandlet med Tredaptive med eller uden et statin.
English: Nicotinic acid: There is no pharmacokinetic data in the elderly (≥ 65 years).
Danish: Nicotinsyre: Farmakokinetiske data for ældre (≥65 år) er ikke tilgængelige.
English: A multicenter, randomized, double-blind, placebo-controlled 32-week study to assess the effects of withdrawal of laropiprant showed that dyslipidaemic patients in whom laropiprant was withdrawn after 20 weeks on Tredaptive experienced significantly more flushing than patients who continued taking Tredaptive in terms of number of days per week with moderate or greater flushing, p< 0.001, Figure 2.
Danish: Et randomiseret, dobbeltblindet, placebokontrolleret 32-ugers multicenterstudie til at vurdere virkningen af seponering af laropiprant viste, at patienter med dyslipidæmi, hvor laropiprant blev seponeret efter 20 uger på Tredaptive, oplevede signifikant mere flushing end patienter, som fortsatte med at tage Tredaptive i form af antal dage pr. uge med moderat eller mere udbredt flushing, p<0,01, figur 2.
English: It is not known if Tredaptive will pass into your breast milk.
Danish: Det er ukendt, om Tredaptive går over i modermælken.
English: In the second study (16 weeks) where acetylsalicylic acid was allowed, patients taking Tredaptive 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 Tredaptive, 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: No studies in lactating animals have been conducted with Tredaptive.
Danish: Der er ikke udført undersøgelser med Tredaptive hos diegivende dyr.
English: There is no difference in the oral bioavailability of nicotinic acid in men and women receiving Tredaptive.
Danish: Der er ingen forskel i nicotinsyres perorale biotilgængelighed hos mænd og kvinder, der får Tredaptive.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Tredaptive in paediatric patients from 7-18 years old in heterozygous familial hypercholesterolaemia (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Tredaptive hos pædiatriske patienter i alderen 7-18 år med heterozygot familiær hyperkolesterolæmi (se pkt.
English: Paediatric population Tredaptive: No studies have been performed in paediatric patients.
Danish: Pædiatrisk population Tredaptive: Der er ikke udført undersøgelser med børn.
English: Caution should be used when Tredaptive is co-administered with medicinal products metabolised predominantly by UGT2B4 or UGT2B7, for instance zidovudine.
Danish: Forsigtighed bør udvises, når Tredaptive administreres sammen med lægemidler, der overvejende metaboliseres af UGT2B4 eller UGT2B7, f.eks. zidovudin.
English: Because the risk of myopathy with statins is dose-related, the use of Tredaptive with simvastatin 80 mg or ezetimibe/simvastatin 10/80 mg is not recommended in Chinese patients.
Danish: Da risikoen for myopati er dosisrelateret, bør Tredaptive ikke gives sammen med simvastatin 80 mg eller ezetimibe/simvastatin 10 mg/80 mg til kinesiske patienter.
English: Further analysis showed Tredaptive (2000 mg/40 mg) co-administered with simvastatin when compared with simvastatin alone significantly increased apo A-I (8.6 %, 2.3 % respectively) and significantly decreased Lp(a) (-19.8 %, 0.0 % respectively ).
Danish: Yderligere analyse viste, at Tredaptive (2.000 mg/40 mg) administreret sammen med simvastatin i sammenligning med simvastatin alene øgede apo-A-I signifikant (henholdsvis 8,6 %, 2,3 %) og reducerede Lp(a) signifikant (henholdsvis -19,8 %, 0,0 %).
English: In particular, tell your doctor or pharmacist if you are taking any of the following:
Danish: Det er særlig vigtigt for lægen eller apoteket at vide, om De tager følgende:
English: As with other nicotinic acid medicinal products, Tredaptive was associated with small decreases in phosphorus levels.
Danish: Som med andre nicotinsyrepræparater er Tredaptive blevet forbundet med små fald i fosfor.
English: Tredaptive is used in addition to diet
Danish: Tredaptive bruges som tillæg til diæt for at:
English: Patients receiving Tredaptive, nicotinic acid (prolonged-released formulation), or placebo were also taking statins (29 % atorvastatin [5-80 mg], 54 % simvastatin [10-80 mg], 17 % other statins [2.5-180 mg] (pravastatin, fluvastatin, rosuvastatin, lovastatin)), of which 9 % were also taking ezetimibe [10 mg].
Danish: Patienter, der fik MK524A, nicotinsyre (depotformulering) eller placebo, tog også statiner (29 % atorvastatin [5-80 mg], 54 % simvastatin [10-80 mg], 17 % andre statiner [2,5-180 mg] (pravastatin, fluvastatin, rosuvastatin, lovastatin)), hvoraf 9 % også tog ezetimibe [10 mg].
English: Like other nicotinic acid medicinal products, Tredaptive is contraindicated in patients with significant or unexplained hepatic dysfunction.
Danish: Som andre nicotinsyrepræparater er Tredaptive kontraindiceret til patienter med signifikant eller uforklarlig leverinsufficiens.
English: What Tredaptive looks like and contents of the pack Each modified-release tablet is a capsule-shaped, white to off-white tablet, with “552” debossed on one side.
Danish: Hver tablet med modificeret udløsning er kapselformet, hvid til off-white, med "552" præget på den ene side.
English: In healthy subjects receiving Tredaptive, pretreatment with acetylsalicylic acid 325 mg had no additional beneficial effects in reducing nicotinic acid-induced flushing symptoms compared to Tredaptive alone (see section 4.8).
Danish: Hos raske forsøgspersoner, der fik Tredaptive, havde forudgående behandling med acetylsalicylsyre 325 mg ingen yderligere gavnlig effekt på reduktionen af nicotinsyreinducerede flushing-symptomer sammenlignet med Tredaptive alene (se pkt.
English: Uncommon: hypersensitivity reaction (see below) Rare: angio-oedema; type I hypersensitivity Not known: anaphylactic shock
Danish: Ikke almindelig: overfølsomhedsreaktion (se nedenfor) Sjælden: angioødem, type1-overfølsomhed Ikke kendt: anafylaktisk shock
English: Clinically important elevations of CK (≥ 10 X ULN) were seen in 0.3 % of the patients treated with Tredaptive with or without a statin (see section 4.4).
Danish: Der sås klinisk relevante stigninger i kreatinkinase (≥ 10 x ULN) hos 0,3 % af de patienter, der blev behandlet med Tredaptive med eller uden et statin (se pkt.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Denne indlægsseddel blev senest ændret {MM/YYYY} De kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Tredaptive should be used in patients in combination with HMG-CoA reductase inhibitors (statins), when the cholesterol lowering effect of HMG-CoA reductase inhibitor monotherapy is inadequate.
Danish: Tredaptive bør anvendes sammen med HMG-CoA reduktasehæmmere (statiner), når den kolesterolsænkende effekt af monoterapi med HMG-CoA-reduktasehæmmere er utilstrækkelig.
English: Caution should be used when treating Chinese patients with Tredaptive co-administered with simvastatin or ezetimibe/simvastatin (particularly simvastatin doses of 40 mg or higher).
Danish: Forsigtighed bør udvises ved behandling af kinesiske patienter med Tredaptive i kombination med simvastatin eller ezetimibe/simvastatin (især ved simvastatindoser på 40 mg eller derover).
English: However, nicotinic acid a component of Tredaptive does pass into breast milk.
Danish: Nicotinsyre, der er en af bestanddelene i Tredaptive, går dog over i modermælken.
English: • you are allergic to nicotinic acid, to laropiprant, or to any of the other ingredients of this medicine (listed in section 6).
Danish: • De er allergisk over for nicotinsyre, laropiprant eller et af de øvrige indholdsstoffer i Tredaptive
English: If you are switching from a medicine with less than 2,000 mg of prolonged-nicotinic acid, you should start by taking one tablet of Tredaptive a day.
Danish: Hvis De skifter fra et depotlægemiddel, der indeholder mindre end 2.000 mg nicotinsyre, skal De starte med at tage én Tredaptive tablet om dagen.
English: • Avoid drinking alcohol or hot drinks or eating spicy foods near the time you take your dose of Tredaptive.
Danish: • Undgå at drikke alkohol eller varme drikke og at spise krydret mad tæt på det tidspunkt, hvor De tager Tredaptive.
English: Following a 2,000 mg dose of nicotinic acid administered orally as two modified-release tablets of nicotinic acid/laropiprant with food, nicotinic acid was absorbed with a median time to peak plasma concentration (Tmax) of 4 hours, a mean area under the plasma concentration-time curve (AUC0-last) of approximately 58.0 μM·hr and a mean peak plasma concentration (Cmax) of approximately 20.2 μM.
Danish: Efter en dosis på 2.000 mg nicotinsyre , der blev administreret peroralt som to tabletter med modificeret udløsning af nicotinsyre/laropiprant sammen med mad, blev nicotinsyren absorberet med en mediantid til peak plasmakoncentration (Tmax) på 4 timer, gennemsnitligt areal under kurven for plasmakoncentrationen over tid (AUC0-last) på ca. 58,0 µM∙t samt gennemsnitlig peak plasmakoncentration (Cmax) på ca. 20,2 µM.
English: Therefore, Tredaptive should be used with caution in patients with or predisposed to gout.
Danish: Tredaptive bør derfor anvendes med forsigtighed hos patienter, der har eller er disponeret for urinsyregigt.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Tredaptive in all subsets of the paediatric population in homozygous familial hypercholesterolaemia (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlæggelse af resultaterne af studier med Tredaptive hos alle undergrupper af den pædiatriske population ved homozygot familiær hyperkolesterolæmi.
English: Tredaptive: Use in patients with renal insufficiency has not been studied.
Danish: Tredaptive: Anvendelse til patienter med nyreinsufficiens er ikke undersøgt.
English: Each tablet contains 1,000 mg nicotinic acid and 20 mg laropiprant.
Danish: Hver tablet indeholder 1.000 mg nicotinsyre og 20 mg laropiprant.
English: Multi-pack containing 196 (2 packs of 98) modified-release tablets 49 x 1 modified-release tablets
Danish: Multipakning indeholdende 196 (2 pakninger à 98) tabletter med modificeret udløsning 49 x 1 tabletter med modificeret udløsning
English: EU/1/08/459/001 14 modified-release tablets EU/1/08/459/002 28 modified-release tablets EU/1/08/459/003 56 modified-release tablets EU/1/08/459/004 84 modified-release tablets EU/1/08/459/005 98 modified-release tablets EU/1/08/459/006 168 modified-release tablets EU/1/08/459/007 196 modified-release tablets EU/1/08/459/008 49 x 1 modified-release tablets EU/1/08/459/012 196 (2 packs of 98) modified-release tablets
Danish: EU/1/08/459/001 14 tabletter med modificeret udløsning EU/1/08/459/002 28 tabletter med modificeret udløsning EU/1/08/459/00356 tabletter med modificeret udløsning EU/1/08/459/004 84 tabletter med modificeret udløsning EU/1/08/459/005 98 tabletter med modificeret udløsning EU/1/08/459/006 168 tabletter med modificeret udløsning EU/1/08/459/007 196 tabletter med modificeret udløsning EU/1/08/459/008 49 x 1 tabletter med modificeret udløsning EU/1/08/459/012 196 (2 pakninger à 98) tabletter med modificeret udløsning
English: Tredaptive contains lactose
Danish: Tredaptive indeholder lactose
English: In rats, foetotoxic effects (significantly decreased foetal body weights associated with a decrease in the number of ossified sacrocaudal vertebrae and an increased incidence of foetuses with sites of incomplete ossification) were noted in the absence of any signs of maternal toxicity at exposure levels approximately 959 times the human AUC of nicotinic acid at the recommended daily human dose.
Danish: Hos rotter sås føtotoksiske virkninger (signifikant nedsat fostervægt associeret med nedsatforbening af korsbenog halehvirvler og en øget forekomst af fostre med stedvis ufuldstændig forbening af knogler) uden at der var tegn på maternel toksicitet ved eksponeringer, der var ca. 959 gange human AUC for nicotinsyre ved anbefalet daglig dosis til mennesker.
English: Because co-administration of bile acid sequestrants may reduce the bioavailability of acidic medicinal products such as nicotinic acid, it is recommended that Tredaptive be administered > 1 hour before or > 4 hours after administration of a bile acid sequestrant (see section 4.5).
Danish: Da samtidig administration af galdesyrebindende lægemidler kan reducere biotilgængeligheden af sure lægemidler, såsom nicotinsyre, bør Tredaptive gives > 1 time før eller > 4 timer efter administration af et galdesyrebindende lægemiddel (se pkt.
English: In patients continuing in the first study (24 weeks), the frequency of moderate or greater flushing in patients treated with Tredaptive declined and approached that of patients receiving placebo (see Figure 1), whereas in patients treated with nicotinic acid (prolonged-release formulation) the flushing frequency remained constant (after Week 6).
Danish: Hos patienter, der fortsatte i den første undersøgelse (24 uger), aftog hyppigheden af moderat eller mere udbredt flushing hos patienter, der blev behandlet med Tredaptive, og nærmede sig reaktionen hos de patienter, der fik placebo (se figur 1).
English: If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Tredaptive.
Danish: Hvis De er i tvivl om noget af ovenstående passer på Dem, skal De tale med lægen eller apoteket, før De tager Tredaptive.
English: • If you are switching from a medicine containing 2,000 mg or more of a prolonged-release nicotinic acid, your doctor can start you with two tablets of Tredaptive a day.
Danish: • Hvis De skifter fra et depotlægemiddel, der indeholder 2.000 mg nicotinsyre eller mere, kan lægen sætte Deres behandling i gang med to Tredaptive-tabletter om dagen.
English: ●Tredaptive (1000 mg/20 mg to 2000 mg/40 mg at week 5) ▲Nicotinic acid (prolonged-release 1000 mg to 2000 mg at week 5)
Danish: ● Tredaptive (1.000 mg/20 mg til 2.000 mg/40 mg ved uge 5)
English: Common: abdominal pain; diarrhoea; dyspepsia; nausea; vomiting Rare: mouth oedema; eructation; peptic ulcer
Danish: Almindelig: abdominalsmerter, diarré, dyspepsi, kvalme, Sjælden: ødem i munden, opstød, ulcus pepticum
English: If Tredaptive is missed for 7 or more consecutive days, therapy should be resumed at the 1,000 mg/20 mg dose for 1 week, before advancing to the maintenance dose of 2,000 mg/40 mg.
Danish: Hvis patienten har undladt at tage Tredaptive i 7 eller flere på hinanden følgende dage, kan behandlingen genoptages med 1.000 mg/20 mg i en uge, før dosis øges til vedligeholdelsesdosis på 2.000 mg/40 mg.
English: Effects of other medicinal products on nicotinic acid Bile acid sequestrants: Because co-administration of bile acid sequestrants may reduce the bioavailability of acidic medicinal products such as nicotinic acid, it is recommended that Tredaptive be administered > 1 hour before or > 4 hours after administration of a bile acid sequestrant.
Danish: Galdesyrebindende lægemidler: Da samtidig administration af galdesyrebindende lægemidler kan reducere biotilgængeligheden af sure lægemidler, såsom nicotinsyre, anbefales det, at Tredaptive administreres >1 time før eller >4 timer efter administration af et galdesyrebindende lægemiddel.
English: NAME OF THE MEDICINAL PRODUCT Tredaptive 1,000 mg/20 mg modified-release tablets.
Danish: LÆGEMIDLETS NAVN Tredaptive 1.000 mg/20 mg tabletter med modificeret udløsning.