FrancophonIA/ELRC3.0 huggingface dataset:
English: Caution should be used when Trevaclyn is co-administered with medicinal products metabolised predominantly by UGT2B4 or UGT2B7, for instance zidovudine.
Danish: Forsigtighed bør udvises, når Trevaclyn 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 Trevaclyn with simvastatin 80 mg or ezetimibe/simvastatin 10/80 mg is not recommended in Chinese patients.
Danish: Da risikoen for myopati er dosisrelateret, bør Trevaclyn ikke gives sammen med simvastatin 80 mg eller ezetimibe/simvastatin 10 mg/80 mg til kinesiske patienter.
English: It is not known if Trevaclyn will pass into your breast milk.
Danish: Det er ukendt, om Trevaclyn går over i modermælken.
English: No studies in lactating animals have been conducted with Trevaclyn.
Danish: Der er ikke udført undersøgelser med Trevaclyn hos diegivende dyr.
English: There is no difference in the oral bioavailability of nicotinic acid in men and women receiving Trevaclyn.
Danish: Der er ingen forskel i nicotinsyres perorale biotilgængelighed hos mænd og kvinder, der får Trevaclyn.
English: In healthy subjects receiving Trevaclyn, pretreatment with acetylsalicylic acid 325 mg had no additional beneficial effects in reducing nicotinic acid-induced flushing symptoms compared to Trevaclyn alone (see section 4.8).
Danish: Hos raske forsøgspersoner, der fik Trevaclyn, havde forudgående behandling med acetylsalicylsyre 325 mg ingen yderligere gavnlig effekt på reduktionen af nicotinsyreinducerede flushing-symptomer sammenlignet med Trevaclyn alene (se pkt.
English: What Trevaclyn 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: As with other nicotinic acid medicinal products, Trevaclyn was associated with small decreases in phosphorus levels.
Danish: Som med andre nicotinsyrepræparater er Trevaclyn blevet forbundet med små fald i fosfor.
English: Clinically important elevations of CK (≥ 10 X ULN) were seen in 0.3 % of the patients treated with Trevaclyn 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 Trevaclyn med eller uden et statin (se pkt.
English: Trevaclyn is used in addition to diet
Danish: Trevaclyn bruges som tillæg til diæt for at:
English: ▲ Trevaclyn  nicotinic acid (laropiprant withdrawn at Week 21)
Danish: ● Trevaclyn ▲ Trevaclyn Æ nicotinsyre (laropiprant seponeret ved uge 21) ○ Placebo
English: Trevaclyn 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: Trevaclyn bør anvendes sammen med HMG-CoA reduktasehæmmere (statiner), når den kolesterolsænkende effekt af monoterapi med HMG-CoA-reduktasehæmmere er utilstrækkelig.
English: Like other nicotinic acid medicinal products, Trevaclyn is contraindicated in patients with significant or unexplained hepatic dysfunction.
Danish: Som andre nicotinsyrepræparater er Trevaclyn kontraindiceret til patienter med signifikant eller uforklarlig leverinsufficiens.
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 Trevaclyn
English: Patients receiving Trevaclyn, 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)),
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 peakplasmakoncentration (Cmax) på ca. 20,2 µM.
English: Caution should be used when treating Chinese patients with Trevaclyn 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 Trevaclyn i kombination med simvastatin eller ezetimibe/simvastatin (især ved simvastatindoser på 40 mg eller derover).
English: • Avoid drinking alcohol or hot drinks or eating spicy foods near the time you take your dose of Trevaclyn.
Danish: • Undgå at drikke alkohol eller varme drikke og at spise krydret mad tæt på det tidspunkt, hvor De tager Trevaclyn.
English: In a pool of four active- or placebo-controlled clinical trials (N=4,747, n=2,548 taking Trevaclyn), flushing was reported in 12.3 % of patients taking Trevaclyn.
Danish: I fire aktive eller placebo-kontrollerede kliniske undersøgelser (N=4.747, n=2.548, der tog Trevaclyn) blev der af investigator rapporteret om flushing som enten en mulig, sandsynlig eller klart behandlingsrelateret bivirkning hos 12,3 % af de patienter, der fik Trevaclyn.
English: There are no adequate data from the use of high dose nicotinic acid in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelsen af højdosis-nicotinsyre til gravide kvinder.
English: Therefore, Trevaclyn should be used with caution in patients with or predisposed to gout.
Danish: Trevaclyn bør derfor anvendes med forsigtighed hos patienter, der har eller er disponeret for urinsyregigt.
English: • See your doctor regularly to check your LDL (bad) and HDL (good) cholesterol levels and your triglyceride level.
Danish: • Gå regelmæssigt til lægen for at få kontrolleret Deres LDL (det "dårlige" kolesterol) og HDL (det "gode" kolesterol) samt indholdet af triglycerider i blodet.
English: In addition, one or more of the following symptoms have been reported as part of an allergic reaction to Trevaclyn.
Danish: Ikke almindelige (kan berøre op til 1 ud af 100 personer) Desuden er en eller flere af følgende symptomer set som del af en allergisk reaktion over for Trevaclyn.
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 Trevaclyn a day.
Danish: Hvis De skifter fra et depotlægemiddel, der indeholder mindre end 2.000 mg nicotinsyre, skal De starte med at tage én Trevaclyn-tablet om dagen.
English: However, nicotinic acid a component of Trevaclyn does pass into breast milk.
Danish: Nicotinsyre, der er en af bestanddelene i Trevaclyn, går dog over i modermælken.
English: EU/1/08/458/001 14 modified-release tablets EU/1/08/458/002 28 modified-release tablets EU/1/08/458/003 56 modified-release tablets EU/1/08/458/004 84 modified-release tablets EU/1/08/458/005 98 modified-release tablets EU/1/08/458/006 168 modified-release tablets EU/1/08/458/007 196 modified-release tablets EU/1/08/458/008 49 x 1 modified-release tablets EU/1/08/458/012 196 (2 packs of 98) modified-release tablets
Danish: EU/1/08/458/001 14 tabletter med modificeret udløsning EU/1/08/458/002 28 tabletter med modificeret udløsning EU/1/08/458/003 56 tabletter med modificeret udløsning EU/1/08/458/004 84 tabletter med modificeret udløsning EU/1/08/458/005 98 tabletter med modificeret udløsning EU/1/08/458/006 168 tabletter med modificeret udløsning EU/1/08/458/007 196 tabletter med modificeret udløsning EU/1/08/458/008 49 x 1 tabletter med modificeret udløsning EU/1/08/458/012 196 (2 pakninger à 98) tabletter med modificeret udløsning
English: The European Medicines Agency has waived the obligation to submit the results of studies with Trevaclyn 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 Trevaclyn hos alle undergrupper af den pædiatriske population ved homozygot familiær hyperkolesterolæmi.
English: Trevaclyn: Use in patients with renal insufficiency has not been studied.
Danish: Trevaclyn: Anvendelse til patienter med nyreinsufficiens er ikke undersøgt.
English: In patients continuing in the first study (24 weeks), the frequency of moderate or greater flushing in patients treated with Trevaclyn 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 Trevaclyn, og nærmede sig reaktionen hos de patienter, der fik placebo (se figur 1).
English: Because co-administration of bile acid sequestrants may reduce the bioavailability of acidic medicinal products such as nicotinic acid, it is recommended that Trevaclyn 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 Trevaclyn gives >1 time før eller > 4 timer efter administration af et galdesyrebindende lægemiddel (se pkt.
English: If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Trevaclyn.
Danish: Hvis De er i tvivl om noget af ovenstående passer på Dem, skal De tale med lægen eller apoteket, før De tager Trevaclyn.
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 Trevaclyn 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 Trevaclyn tabletter om dagen.
English: PHARMACEUTICAL FORM AND CONTENTS 98 modified-release tablets.
Danish: LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) 98 tabletter med modificeret udløsning.
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 nedsat forbening af korsbens og 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: Tel.: +420 233 010 111 msd_cr@merck.com
Danish: : +420 233 010 111 msd_cr@merck.com
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 Trevaclyn 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 Trevaclyn administreres >1 time før eller > 4 timer efter administration af et galdesyrebindende lægemiddel.
English: Very common: flushing Uncommon: hypotension Rare: orthostatic hypotension
Danish: Vaskulære sygdomme: Hypotension, ortostatisk hypotension.
English: Common: elevations in ALT and/or AST (consecutive, ≥ 3 X ULN), fasting glucose (see below) Uncommon: elevations in CK (≥ 10 X ULN), LDH, uric acid (see
Danish: Stigninger i ALAT og/eller ASAT (konsekutivt, ≥ 3 x ULN), fasteglucose, urinsyre (se nedenfor).
English: If Trevaclyn 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 Trevaclyn 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: Trevaclyn is used in addition to diet and exercise in adult patients with primary hypercholesterolaemia or mixed dyslipidaemia:
Danish: Trevaclyn bruges som tillæg til diæt og motion hos voksne patienter med primær hyperkolesterolæmi eller blandet dyslipidæmi (dvs. ændringer i blodets indhold af fedtstoffer):
English: In a multicentre, double-blind, 24-week placebo-controlled study, patients taking Trevaclyn (2,000 mg/40 mg) with or without a statin, when compared to placebo, had significantly decreased LDL-C (-18.9 % vs. -0.5 %), TG (-21.7 % vs. 3.6 %), LDL-C:HDL-C (-28.9 % vs. 2.3 %), non-HDL-C (-19.0 % vs. 0.8 %), apo B (-16.4 % vs. 2.5 %), TC (-9.2 % vs. -0.6 %), Lp(a) (-17.6 % vs. 1.1 %), and TC:HDL-C (-21.2 % vs. 1.9 %) and also had significantly increased HDL-C (18.8 % vs. -1.2 %), and apo A-I (11.2 % vs. 4.3 %) as measured by percent change from baseline.
Danish: I en multicenter, dobbeltblindet, 24-ugers placebokontrolleret undersøgelse havde de patienter, der tager Trevaclyn (2.000 mg/40 mg) med eller uden statin, i sammenligning med placebo, signifikant nedsat LDL-C (-18,9 % versus -0,5 %), TG (-21,7 % versus 3,6 %), LDL-C:HDL-C (-28,9 % versus 2,3 %), non-HDL-C (-19,0 % versus 0,8 %) apo-B (-16,4 % versus 2,5 %), TC (-9,2 % versus -0,6 %), Lp(a) (-17,6 % versus 1,1 %) og TC:HDL-C (-21,2 % versus 1,9 %) og havde også signifikant øget HDL-C (18,8 % versus -1,2 %) og apo-A-I (11,2 % versus 4,3 %) målt som ændring i procent i forhold til baseline.
English: As with other nicotinic acid medicinal products, elevations in fasting glucose (a median increase of approximately 4 mg/dL), and uric acid (mean change from baseline of +14.7 %), and reductions in platelet counts (a mean change from baseline of -14.0 %) were reported in controlled clinical studies with Trevaclyn (2,000 mg/40 mg) (see section 4.4).
Danish: Som med andre nicotinsyrepræparater er der i kontrollerede kliniske undersøgelser med Trevaclyn (2.000 mg/40 mg) rapporteret om stigninger i fasteglucose (en gennemsnitlig stigning på ca. 4 mg/dl), urinsyre (gennemsnitlig ændring i forhold til baseline på +14,7 %) samt fald i antal blodplader (en gennemsnitlilg ændring i forhold til baseline på -14,0 %) (se pkt.
English: Trevaclyn (2000 mg/40 mg) co-administered with simvastatin when compared with simvastatin alone or Trevaclyn (2000 mg/40 mg) alone for 12 weeks, significantly lowered LDL-C (-47.9 %, -37.0 %, -17.0 % respectively), TG (-33.3 %, -14.7 %, -21.6 % respectively), apo B (-41.0 %, -28.8 %, -17.1 % respectively), and TC (-29.6 %, -24.9 %, -9.1 % respectively), as well as LDL-C:HDL-C (-57.1 %, -39.8 %, -31.2 % respectively), non-HDL-C (-45.8 %, -33.4 %, -18.1 % respectively), and TC:HDL-C (-43.0 %, -28.0 %, -24.9 % respectively), and significantly increased HDL-C (27.5 %, 6.0 %, 23.4 % respectively).
Danish: Sammenlignet med simvastatin alene eller Trevaclyn (2.000 mg/40 mg) alene i 12 uger sænkede Trevaclyn (2.000 mg/40 mg) sammen med simvastatin LDL-C (henholdsvis -47,9 %, -37,0 %, -17,0 %), TG (henholdsvis -33,3 %, -14,7 %,21,6 %), apo B (henholdsvis -41,0 %, -28,8 %, -17,1 %) og TC (henholdsvis -29,6 %, -24,9 %, 9,1 %) samt LDL-C:HDL-C (henholdsvis -57,1 %, -39,8 %, -31,2 %), non-HDL-C (henholdsvis -45,8 %, -33,4 %, -18,1 %) og TC:HDL-C (henholdsvis -43,0 %, -28,0 %, -24,9 %) signifikant og øgede HDLC signifikant (henholdsvis 27,5 %, 6,0 %, 23,4 %).
English: ●Trevaclyn (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: ● Trevaclyn (1.000 mg/20 mg til 2.000 mg/40 mg ved uge 5) ▲Nicotinsyre (depotformulering 1.000mg to 2.000 mg ved uge 5) ○Placebo *Inkluderer patienter med moderate, svære eller ekstreme flushing-symptomer †Øgning af dosis ved uge 5
English: Therefore, patients switching from immediate-release nicotinic acid to Trevaclyn should be initiated at the 1,000 mg/20 mg dose.
Danish: Patienter, der skifter fra nicotinsyre med umiddelbar udløsning til Trevaclyn, bør derfor starte med 1.000 mg/20 mg.
English: 14 modified-release tablets 28 modified-release tablets 56 modified-release tablets 168 modified-release tablets 32 x 1modified-release tablets
Danish: 14 tabletter med modificeret udløsning 28 tabletter med modificeret udløsning 56 tabletter med modificeret udløsning 168 tabletter med modificeret udløsning 32 x 1 tabletter med modificeret udløsning
English: Uncommon: palpitations Rare: atrial fibrillation and other cardiac arrhythmias; tachycardia
Danish: Hjerte: Atrieflimren og andre hjertearytmier, palpitationer, takykardi.
English: • To lower your chance of flushing, avoid drinking alcohol or hot drinks or eating spicy foods near the time you take your dose of Trevaclyn.
Danish: • For at mindske risikoen for rødmen bør De undgå at drikke alkohol eller varme drikke og at spise krydret mad tæt på det tidspunkt, hvor De tager Trevaclyn.
English: How Trevaclyn Works
Danish: Sådan virker Trevaclyn
English: Hepatic insufficiency Trevaclyn: Use in patients with hepatic insufficiency has not been studied.
Danish: Leverinsufficiens Trevaclyn: Anvendelse til patienter med leverinsufficiens er ikke undersøgt.
English: In an interim analysis of an ongoing clinical outcome study, an independent safety monitoring committee identified a higher than expected incidence of myopathy in Chinese patients taking Trevaclyn and simvastatin 40 mg.
Danish: I en interimanalyse af en igangværende outcome-undersøgelse identificerede en uafhængig sikkerhedsmonitoreringskomité en højere incidens af myopati end forventet hos kinesiske patienter, der tog Trevaclyn og simvastatin 40 mg. Der bør derfor udvises forsigtighed, når kinesiske patienter behandles med Trevaclyn sammen med simvastatin eller ezetimibe/simvastatin (især ved simvastatindoser på 40 mg eller derover).
English: Trevaclyn contains lactose.
Danish: Trevaclyn indeholder lactose.
English: As with other nicotinic acid medicinal products, Trevaclyn (2,000 mg/40 mg) was associated with small increases in uric acid levels (see section 4.8).
Danish: Som med andre nicotinsyrepræparater er Trevaclyn (2.000 mg/40 mg) blevet forbundet med små stigninger i urinsyrekoncentrationen (se pkt.
English: Those patients switching from 2,000 mg or more of prolonged-release nicotinic acid can initiate Trevaclyn at the 2,000 mg/40 mg dose.
Danish: Patienter, som skifter fra 2.000 mg eller mere af et nicotinsyredepotpræparat, kan starte behandling med Trevaclyn med en dosis på 2.000 mg/40 mg.
English: Trevaclyn contains lactose
Danish: Trevaclyn indeholder lactose
English: Triglycerides are another fat in your blood.
Danish: Triglycerider er et andet fedtstof i blodet, der kan øge risikoen for at få hjerteproblemer.
English: In a multicentre, double-blind, 12-week factorial study, Trevaclyn 1,000 mg/20 mg co-administered with simvastatin, when compared with simvastatin alone or Trevaclyn 1,000 mg/20 mg alone, for 4 weeks, significantly lowered LDL-C (-44.2 %, -37.4 %, -8.2 % respectively), TG (-25.8 %, -15.7 %, -18.7 % respectively), TC (-27.9 %, -25.8 %, -4.9 % respectively) and significantly increased HDL-C (19.2 %, 4.2 %, 12.5 % respectively).
Danish: I en multicenter, dobbeltblindet 12-ugers faktoriel undersøgelse reducerede Trevaclyn1.000 mg/20 mg og simvastatin signifikant LDL-C (henholdsvis -44,2 %, -37,4 % og -8,2 %), TG (henholdsvis -25,8 %, -15,7 % og -18,7 %), TC (henholdsvis -27,9 %, -25,8 % og -4,9 %), når det blev sammenlignet med simvastatin alene eller Trevaclyn 1.000 mg/20 alene i 4 uger.
English: Use of Trevaclyn in patients with hepatic or renal insufficiency has not been studied.
Danish: Anvendelse af Trevaclyn er ikke undersøgt hos patienter med lever- eller nyreinsufficiens.
English: NAME OF THE MEDICINAL PRODUCT Trevaclyn 1,000 mg/20 mg modified-release tablets.
Danish: LÆGEMIDLETS NAVN Trevaclyn 1.000 mg/20 mg tabletter med modificeret udløsning.
English: Common: erythema; pruritus; rash; urticaria Uncommon: dry skin; macular rash Rare: acanthosis nigricans; hyperpigmentation; sweating (night or cold sweat)
Danish: Hud og subkutane væv: Acanthosis nigricans, tør hud, hyperpigmentering, makuløst udslæt, svedtendens (natte- eller koldsved), vesikuløst eller vesikulobulløst udslæt.
English: Trevaclyn 1,000 mg/20 mg modified-release tablets nicotinic acid/laropiprant
Danish: Trevaclyn 1.000 mg/20 mg tabletter med modificeret udløsning nicotinsyre/laropiprant
English: How to take Trevaclyn
Danish: Sådan skal De tage Trevaclyn
English: Additional adverse reactions reported with other nicotinic acid medical products Additional adverse reactions that have been reported with other nicotinic acid medicinal products (with or without a statin) in post-marketing use or in clinical trials include the following:
Danish: Post-marketing erfaring og erfaring fra kliniske undersøgelser Yderligere bivirkninger, som er blevet rapporteret efter markedsføring under behandling med Trevaclyn eller andre nicotinsyrepræparater (med eller uden statin) med ukendt frekvens eller i kliniske undersøgelser med Trevaclyn (<1% af patienterne) eller andre nicotinsyrepræparater (med eller uden statin), omfatter følgende:
English: As with other nicotinic acid medicinal products, Trevaclyn (2,000 mg/40 mg) was associated with small reductions in platelet count (see section 4.8).
Danish: Som med andre nicotinsyrepræparater er Trevaclyn (2.000 mg/40 mg) blevet forbundet med små reduktioner i antallet af blodplader (se pkt.
English: For patients switching from immediate-release nicotinic acid to Trevaclyn, therapy should be initiated at the 1,000 mg/20 mg dose and advanced to the 2,000 mg/40 mg maintenance dose after four weeks.
Danish: Patienter, der skifter fra nicotinsyre med umiddelbar udløsning til Trevaclyn, bør starte behandling med 1.000 mg/20 mg og overgå til en vedligeholdelsesdosis på 2.000 mg/40 mg efter fire uger.
English: • migraine
Danish: • Hovedpine
English: Rare: elevations in total bilirubin, amylase; reductions in phosphorus and platelet counts (see below)
Danish: Stigninger i kreatinkinase (≥ 10 x ULN), totalt bilirubin, fald i fosfor og trombocyttal (se nedenfor).
English: Uncommon: insomnia Rare: anxiety
Danish: Psykiske forstyrrelser: Angst, søvnløshed.
English: Following a 40 mg dose of laropiprant administered orally as two modified-release tablets of nicotinic acid/laropiprant with food, laropiprant is rapidly absorbed with a median Tmax of 1 hour, a mean
Danish: Efter en 40 mg laropiprantdosis, der blev administreret peroralt som to tabletter med modificeret udløsning af nicotinsyre/laropiprant sammen med mad, absorberedes laropiprant hurtigt med en median Tmax på 1 time, gennemsnitlig AUC0-∞ på ca. 13 µM·t og en gennemsnitlig Cmax på ca. 1,6 µM.