natgillin/translations-raw huggingface dataset:
Det vides ikke, om der er en øget risiko for myopati hos andre asiatiske patienter, som behandles med Tredaptive samtidigt med simvastatin eller ezetimibe/simvastatin.
It is unknown whether there is an increased risk of myopathy in other Asian patients treated with Tredaptive co-administered with simvastatin or ezetimibe/simvastatin.
Indvirkningen på lipider var den samme, hvad enten Tredaptive blev givet som monoterapi eller blev tilføjet til den igangværende statinbehandling med eller uden ezetimibe.
The effect on lipids was similar whether Tredaptive was given as monotherapy or was added to ongoing statin therapy with or without ezetimibe.
I kliniske undersøgelser har mere end 5.700 patienter fået Tredaptive alene eller sammen med en HMG-CoA-reduktasehæmmer.
In clinical trials, over 5,700 patients received Tredaptive alone or with an HMG-CoA reductase inhibitor.
Hvis patienten har undladt at tage Tredaptive i færre end 7 på hinanden følgende dage, kan behandlingen genoptages ved den senest administrerede dosis.
If Tredaptive is missed for less than 7 consecutive days, patients can resume therapy at the last administered dose.
▲ Tredaptive  nicotinsyre (laropiprant seponeret ved uge 21)
▲ Tredaptive  nicotinic acid (laropiprant withdrawn at Week 21)
De må ikke holde op med at tage Tredaptive uden at tale med lægen.
If you stop taking Tredaptive Do not stop taking Tredaptive without talking to your doctor.
Incidensen og hyppigheden af moderat og mere udbredt flushing hos patienter, der fik Tredaptive i hele studiets varighed, faldt.
The incidence and frequency of moderate or greater flushing in patients treated with Tredaptive for the duration of the study decreased.
Figur 2 Procentdel af patienter med moderate eller mere udbredte flushing-symptomer hen over ugerne 1-32
Figure 2 Percentage of Patients with Moderate or Greater Flushing Symptoms Across Weeks 1-32
Ikke kendt: hyppigheden kan ikke vurderes ud fra tilgængelige data Desuden er følgende bivirkninger blevet rapporteret efter markedsføring af Tredaptive og/eller andre nicotinsyrepræparater (alene og/eller sammen med visse andre kolesterolsænkende lægemidler):
Not known: frequency cannot be estimated from the available data Additionally, the following were reported during post-marketing experience with Tredaptive and/or other nicotinic acid products (alone and/or with certain other cholesterol-lowering medicines):
Hvis muskelsmerter, -svaghed eller -kramper opstår, mens patienten er i behandling med Tredaptive sammen med et statin, skal CK-koncentrationerne måles.
If muscle pain, weakness or cramps occur while a patient is receiving Tredaptive with a statin, their CK levels should be measured.
Patienter, der får Tredaptive 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.
Patients receiving Tredaptive 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.
Læger, som overvejer kombinationsbehandling med statiner og Tredaptive, 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.
Physicians contemplating combined therapy with statins and Tredaptive 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.
Når Tredaptive gives samtidigt med et statin henvises til produktresuméet for dette specifikke lægemiddel.
When Tredaptive is co-administered with a statin, please refer to the Summary of Product Characteristics for that particular medicinal product.
I fire aktive eller placebo-kontrollerede kliniske undersøgelser (N=4.747, n=2.548, der tog Tredaptive) blev der rapporteret om flushing hos 12,3 % af de patienter, der fik Tredaptive.
In a pool of four active- or placebo-controlled clinical trials (N=4,747, n=2,548 taking Tredaptive), flushing was reported in 12.3 % of patients taking Tredaptive.
Coronary Drug Project, en fem-årig undersøgelse, der afsluttedes i 1975, viste, at nicotinsyre havde en statistisk signifikant positivindvirkning på reduktionen af nonfatale, tilbagevendende myokardieinfarkter (MI) hos mænd i alderen 30-64 år med MI i anamnesen.
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.
Hvis De har glemt at tage Tredaptive
If you forget to take Tredaptive
Men hvis De ikke har taget Tredaptive i 7 dage eller mere i træk, skal De tale med lægen, før De igen begynder at tage Tredaptive.
However, if you do not take Tredaptive for 7 or more days in a row, talk to your doctor before restarting Tredaptive.
Tredaptive 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.
Tredaptive was consistently efficacious across all prespecified patient subpopulations defined by race, gender, baseline LDL-C, HDL-C and TG levels, age and diabetes status.
Tredaptive er ikke undersøgt hos børn og unge under 18 år.
Tredaptive has not been studied in children and adolescents who are under 18 years of age.
Indtagelse af alkohol eller varme drikke eller krydret mad kan forstærke flushing-effekten og bør derfor undgås omkring tidspunktet for indtagelse af Tredaptive.
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.
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.
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.
Tredaptives farmakokinetiske interaktion med statiner er kun blevet undersøgt for simvastatin (se pkt.
The pharmacokinetic interaction of Tredaptive with statins has been studied only with simvastatin (see section 4.4).
Yderligere information om Tredaptive findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Hvis disse koncentrationer viser sig at være signifikant forhøjede (> 5 x ULN), uden forudgående hård motion, bør behandlingen stoppes.
If these levels are found, in the absence of strenuous exercise, to be significantly elevated (> 5 x ULN), treatment should be stopped.
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).
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).
• At tage acetylsalicylsyre før De tager Tredaptive vil ikke mindske Deres rødmen mere, end hvis De tager Tredaptive alene.
• Taking aspirin before you take Tredaptive does not reduce your flushing more than taking Tredaptive alone.
Følgende bivirkninger er rapporteret under de kliniske studier og/eller ved brug af Tredaptive efter markedsføring (med eller uden et statin).
The following adverse reactions have been reported during clinical studies and/or post-marketing use with Tredaptive (with or without a statin).
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.
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.
Tredaptive bør anvendes med forsigtighed hos patienter, som indtager væsentlige mængder alkohol og/eller har leversygdom i anamnesen.
Tredaptive should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease.
MSD ItaliaS.r.l.
MSD Italia S.r.l.
Da nicotinsyre og dets metabolitter udskilles via nyrerne, bør Tredaptive anvendes med forsigtighed hos patienter med nyreinsufficiens.
Because nicotinic acid and its metabolites are excreted through the kidneys, Tredaptive should be used with caution in patients with renal dysfunction.
Hvis en forhøjelse i alaninaminotransferase (ALAT) eller aspartataminotransferase (ASAT) af ≥ 3 x ULN (øvre normalgrænse) varer ved, bør Tredaptive reduceres eller seponeres.
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.
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 %.
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.
Tredaptive kan anvendes som monoterapi hos patienter, hvor HMG-CoA-reduktasehæmmere anses for at være uhensigstmæssige eller ikke tåles.
It can be used as monotherapy only in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated.
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).
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).
Det skal De vide, før De begynder at tage Tredaptive
What you need to know before you take Tredaptive
Kosttilskud med nicotinsyre: Vitaminer eller andre ernæringstilskud med (≥ 50 mg /dag) nicotinsyre (eller nicotinamid) er ikke blevet undersøgt sammen med Tredaptive.
Supplements containing nicotinic acid: Vitamins or other nutritional supplements containing (≥ 50 mg/day) of nicotinic acid (or nicotinamide) have not been studied with Tredaptive.
Tredaptive indeholder et sukkerstof, der kaldes lactose.
Tredaptive contains a sugar called lactose.
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).
In three large clinical trials measuring patient-reported flushing symptoms, patients taking Tredaptive experienced less flushing than those taking nicotinic acid (prolonged-release formulations).
Skift fra nicotinsyre med umiddelbar udløsning (krystallinsk) til Tredaptive er ikke undersøgt.
Switching from immediate-release (crystalline) nicotinic acid to Tredaptive has not been studied.
Lægen bør overveje indtaget af nicotinsyre fra vitaminer og enæringstilskud, når Tredaptive ordineres.
Physicians should consider the nicotinic acid intake from vitamins and nutritional supplements when prescribing Tredaptive.
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.
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.
Nicotinsyre: Farmakokinetiske data for ældre (≥65 år) er ikke tilgængelige.
Nicotinic acid: There is no pharmacokinetic data in the elderly (≥ 65 years).
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.
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.
Det er ukendt, om Tredaptive går over i modermælken.
It is not known if Tredaptive will pass into your breast milk.
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).
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).
Der er ikke udført undersøgelser med Tredaptive hos diegivende dyr.
No studies in lactating animals have been conducted with Tredaptive.
Der er ingen forskel i nicotinsyres perorale biotilgængelighed hos mænd og kvinder, der får Tredaptive.
There is no difference in the oral bioavailability of nicotinic acid in men and women receiving Tredaptive.
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.
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).
Pædiatrisk population Tredaptive: Der er ikke udført undersøgelser med børn.
Paediatric population Tredaptive: No studies have been performed in paediatric patients.
Forsigtighed bør udvises, når Tredaptive administreres sammen med lægemidler, der overvejende metaboliseres af UGT2B4 eller UGT2B7, f.eks. zidovudin.
Caution should be used when Tredaptive is co-administered with medicinal products metabolised predominantly by UGT2B4 or UGT2B7, for instance zidovudine.
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.
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.
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 %).
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 ).
Det er særlig vigtigt for lægen eller apoteket at vide, om De tager følgende:
In particular, tell your doctor or pharmacist if you are taking any of the following:
Som med andre nicotinsyrepræparater er Tredaptive blevet forbundet med små fald i fosfor.
As with other nicotinic acid medicinal products, Tredaptive was associated with small decreases in phosphorus levels.
Tredaptive bruges som tillæg til diæt for at:
Tredaptive is used in addition to diet
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].
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].
Som andre nicotinsyrepræparater er Tredaptive kontraindiceret til patienter med signifikant eller uforklarlig leverinsufficiens.
Like other nicotinic acid medicinal products, Tredaptive is contraindicated in patients with significant or unexplained hepatic dysfunction.
Hver tablet med modificeret udløsning er kapselformet, hvid til off-white, med "552" præget på den ene side.
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.
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.
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).
Ikke almindelig: overfølsomhedsreaktion (se nedenfor) Sjælden: angioødem, type1-overfølsomhed Ikke kendt: anafylaktisk shock
Uncommon: hypersensitivity reaction (see below) Rare: angio-oedema; type I hypersensitivity Not known: anaphylactic shock
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.
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).
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/.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Tredaptive bør anvendes sammen med HMG-CoA reduktasehæmmere (statiner), når den kolesterolsænkende effekt af monoterapi med HMG-CoA-reduktasehæmmere er utilstrækkelig.
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.
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).
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).
Nicotinsyre, der er en af bestanddelene i Tredaptive, går dog over i modermælken.
However, nicotinic acid a component of Tredaptive does pass into breast milk.
• De er allergisk over for nicotinsyre, laropiprant eller et af de øvrige indholdsstoffer i Tredaptive
• you are allergic to nicotinic acid, to laropiprant, or to any of the other ingredients of this medicine (listed in section 6).
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.
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.
• Undgå at drikke alkohol eller varme drikke og at spise krydret mad tæt på det tidspunkt, hvor De tager Tredaptive.
• Avoid drinking alcohol or hot drinks or eating spicy foods near the time you take your dose of Tredaptive.
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.
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.
Tredaptive bør derfor anvendes med forsigtighed hos patienter, der har eller er disponeret for urinsyregigt.
Therefore, Tredaptive should be used with caution in patients with or predisposed to gout.
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.
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).
Tredaptive: Anvendelse til patienter med nyreinsufficiens er ikke undersøgt.
Tredaptive: Use in patients with renal insufficiency has not been studied.
Hver tablet indeholder 1.000 mg nicotinsyre og 20 mg laropiprant.
Each tablet contains 1,000 mg nicotinic acid and 20 mg laropiprant.
Multipakning indeholdende 196 (2 pakninger à 98) tabletter med modificeret udløsning 49 x 1 tabletter med modificeret udløsning
Multi-pack containing 196 (2 packs of 98) modified-release tablets 49 x 1 modified-release tablets