natgillin/translations-raw huggingface dataset:
What Trevaclyn is and what it is used for What you need to know before you take Trevaclyn How to take Trevaclyn
Kaj je zdravilo Trevaclyn in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Trevaclyn Kako jemati zdravilo Trevaclyn Možni neželeni učinki
Paediatric population Trevaclyn: No studies have been performed in paediatric patients.
Pediatrična populacija Trevaclyn: Študij pri pediatričnih bolnikih niso izvedli.
Trevaclyn has not been studied in children and adolescents who are under 18 years of age.
Zdravilo Trevaclyn ni raziskano pri otrocih in mladostnikih, mlajših od 18 let.
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.
HDL holesterol pogosto imenujemo "dobri" holesterol, ker pomaga preprečevati kopičenje "slabega" holesterola v arterijah in ker varuje pred boleznijo srca.
Trevaclyn is not recommended in pregnancy unless clearly necessary.
Zdravila Trevaclyn v nosečnosti ne priporočamo, razen če je nujno potrebno.
If you get dizzy, you should avoid driving or operating machines after taking Trevaclyn.
Če postanete omotični, se med jemanjem zdravila Trevaclyn izogibajte vožnji ali upravljanju strojev.
It is not known if Trevaclyn will pass into your breast milk.
Ni znano, ali Trevaclyn prehaja v materino mleko.
The effect on lipids was similar whether Trevaclyn was given as monotherapy or was added to ongoing statin therapy with or without ezetimibe.
Učinek na lipide je bil podoben, naj je bilo zdravilo Trevaclyn uporabljeno v monoterapiji ali dodano že vpeljanemu statinskemu zdravljenju, z ezetimibom ali brez njega.
Other medicines and Trevaclyn
Druga zdravila in zdravilo Trevaclyn
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).
Klinično pomembno zvišanje CK (≥ 10 x ZNM) so opazili pri 0,3 % bolnikov, ki so dobivali zdravilo Trevaclyn s statinom ali brez njega (glejte poglavje 4.4).
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.
V vmesni analizi trenutno potekajoče preživetvene študije je neodvisen odbor za spremljanje varnosti odkril višjo pojavnost miopatije pri kitajskih bolnikih, ki so jemali zdravilo Trevaclyn in simvastatin 40 mg, kot je bilo pričakovano.
If you take more Trevaclyn than you should
Če ste vzeli večji odmerek zdravila Trevaclyn, kot bi smeli
Trevaclyn is used in addition to diet and exercise in adult patients with primary hypercholesterolaemia or mixed dyslipidaemia:
Zdravilo Trevaclyn se uporablja poleg diete in telesne vadbe pri odraslih bolnikih s primarno hiperholesterolemijo ali z mešano dislipidemijo:
PHARMACEUTICAL FORM AND CONTENTS 98 modified-release tablets.
FARMACEVTSKA OBLIKA IN VSEBINA 98 tablet s prirejenim sproščanjem.
As with other nicotinic acid medicinal products, caution should be used when Trevaclyn 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.
Tako kot velja za druga zdravila z nikotinsko kislino, je tudi pri zdravilu Trevaclyn potrebna previdnost, če ga uporabljate pri bolnikih z nestabilno angino pektoris ali med akutno fazo MI, zlasti kadar takšni bolniki dobivajo tudi vazoaktivna zdravila, kot so nitrati, zaviralci kalcijevih kanalov ali adrenergični zaviralci.
INFORMATION IN BRAILLE Trevaclyn
PODATKI V BRAILLOVI PISAVI Trevaclyn
Trevaclyn should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease.
Zdravilo Trevaclyn morate previdno uporabljati pri bolnikih, ki uživajo velike količine alkohola in/ali imajo anamnezo bolezni jeter.
Trevaclyn is used in addition to diet
Zdravilo Trevaclyn se uporablja poleg diete za:
If you stop taking Trevaclyn Do not stop taking Trevaclyn without talking to your doctor.
Ne nehajte jemati zdravila Trevaclyn, ne da bi se posvetovali s svojim zdravnikom.
It should be used with caution in patients with renal insufficiency, because nicotinic acid and its metabolites are primarily excreted by the kidneys (see sections 4.3, 4.4 and 5.2).
Previdno ga morate uporabljati pri bolnikih z ledvično insuficienco, kajti nikotinska kislina in njeni presnovki se izločajo predvsem skozi ledvice (glejte poglavja 4.3, 4.4 in 5.2.)
Trevaclyn 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).
Zdravilo Trevaclyn vsebuje nikotinsko kislino, ki v terapevtskih odmerkih vpliva na lipide, in laropiprant, močan, selektiven antagonist receptorja prostaglandina D2 (PGD2) podvrste 1 (DP1).
However, if you do not take Trevaclyn for 7 or more days in a row, talk to your doctor before restarting Trevaclyn.
Če pa se zgodi, da zdravila Trevaclyn niste vzeli 7 ali več dni zapored, se pred ponovnim začetkom jemanja posvetujte z zdravnikom.
Supplements containing nicotinic acid: Vitamins or other nutritional supplements containing (≥ 50 mg/day) of nicotinic acid (or nicotinamide) have not been studied with Trevaclyn.
Dodatki, ki vsebujejo nikotinsko kislino: Uporaba vitaminov in drugih prehranskih dopolnil, ki vsebujejo (≥ 50 mg/dan) nikotinsko kislino (ali nikotinamid) hkrati z zdravilom Trevaclyn ni raziskana.
Should an increase in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of ≥ 3 X ULN persist, reduction of dose or withdrawal of Trevaclyn is recommended.
Če zvišanje vrednosti alanin aminotransferaze (ALT) ali aspartat aminotransferaze (AST) na ≥ 3 x ZMN (zgornja meja normalne vrednosti) vztraja, je priporočljivo zmanjšati odmerek zdravila Trevaclyn ali pa zdravilo Trevaclyn prenehati uporabljati.
• Taking aspirin before you take Trevaclyn does not reduce your flushing more than taking Trevaclyn alone.
• Jemanje acetilsalicilne kisline pred zaužitjem zdravila Trevaclyn ne bo bolj zmanjšalo zardevanja, kot če vzamete samo zdravilo Trevaclyn.
Trevaclyn contains a sugar called lactose.
Trevaclyn vsebuje sladkor, imenovan laktoza.
If you forget to take Trevaclyn
Če ste pozabili vzeti zdravilo Trevaclyn
Trevaclyn 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).
Zdravilo Trevaclyn je indicirano za zdravljenje dislipidemije, zlasti pri odraslih bolnikih s kombinirano mešano dislipidemijo (za katero so značilni zvišani LDL holesterol in trigliceridi in nizek HDL holesterol), in pri odraslih bolnikih s primarno hiperholesterolemijo (heterozigotno družinsko in nedružinsko).
In humans, nicotinamide is further predominantly metabolised to N-methylnicotinamide (MNA) and to N-methyl-2-pyridone-5-carboxamide (2PY).
Pri človeku se nikotinamid nato presnovi v glavnem v N-metilnikotinamid (MNA) in N-metil-2-piridon-5-karboksamid (2PY).
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).
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom Trevaclyn za vse skupine pediatrične populacije s homozigotno družinsko hiperholesterolemijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Switching from immediate-release (crystalline) nicotinic acid to Trevaclyn has not been studied.
Prehod z nikotinske kisline s takojšnjim sproščanjem (kristalne nikotinske kisline) na zdravilo Trevaclyn ni raziskan.
If Trevaclyn is missed for less than 7 consecutive days, patients can resume therapy at the last administered dose.
Če bolnik zdravila Trevaclyn ne vzame manj kot 7 dni zapored, ga lahko znova začne jemati v nazadnje uporabljanem odmerku.
Like other nicotinic acid medicinal products, Trevaclyn is contraindicated in patients with significant or unexplained hepatic dysfunction.
Tako kot druga zdravila z nikotinsko kislino je tudi zdravilo Trevaclyn kontraindicirano pri bolnikih s pomembno ali nepojasnjeno motnjo delovanja jeter.
The European Medicines Agency has deferred the obligation to submit the results of studies with Trevaclyn in paediatric patients from 7-18 years old in heterozygous familial hypercholesterolaemia (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom Trevaclyn pri pediatričnih bolnikih s heterozigotno družinsko hiperholesterolemijo, starih od 7-18 let (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
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].
Bolniki, ki so dobivali zdravilo Trevaclyn, nikotinsko kislino (pripravek s podaljšanim sproščanjem), ali placebo, so jemali tudi statine (29 % atorvastatin [5-80 mg], 54 % simvastatin [10-80 mg], 17 % druge statine [2,5-180 mg] (pravastatin, fluvastatin, rosuvastatin, lovastatin)) in 9 % od teh jih je jemalo tudi ezetimib [10 mg].
CYP3A4 Inhibitor: Clarithromycin (a potent inhibitor of CYP3A4 and P-gp) did not have a clinically meaningful effect on the pharmacokinetics of laropiprant.
Zaviralec CYP3A4: Klaritromicin (močan zaviralec CYP3A4 in P-gp) ni klinično pomembno vplival na farmakokinetiko laropipranta.
The tablets should be taken whole, with food, in the evening or at bedtime.
Tablete Trevaclyn mora bolnik vzeti cele, s hrano, zvečer ali pred spanjem.
Flushing is the most common adverse reaction of Trevaclyn.
Zardevanje je najpogostejši neželeni učinek zdravila Trevaclyn.
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)
Multi pakiranje po 196 (2 zavoja po 98 tablet s prirejenim sproščanjem) - brez blue box-a (s PVC/Aclar pretisnimi omoti)
Not known: frequency cannot be estimated from the available data Additionally, the following were reported during post-marketing experience with Trevaclyn and/or other nicotinic acid products (alone and/or with certain other cholesterol-lowering medicines).
Neznana: pogostnosti ni mogoče oceniti iz razpoložljivih podatkov Poleg tega so v obdobju trženja zdravila Trevaclyn in/ali drugih zdravil z nikotinsko kislino (samostojno in/ali skupaj z določenimi drugimi zdravili za zniževanje ravni holesterola) poročali o nenadni resni alergijski reakciji (anafilaktičnem šoku).
When Trevaclyn is co-administered with a statin, please refer to the Summary of Product Characteristics for that particular medicinal product.
Če zdravilo Trevaclyn uporabljate skupaj s statinom, morate upoštevati Povzetek glavnih značilnosti za to zdravilo.
• Your doctor may also want you to periodically have blood tests after you start taking Trevaclyn, to check how well your liver is working and for other side effects.
• Morda vas bo zdravnik na preiskave krvi napotil tudi med zdravljenjem z zdravilom Trevaclyn, da bo preveril delovanje vaših jeter in druge neželene učinke.
The pharmacokinetic interaction of Trevaclyn with statins has been studied only with simvastatin (see section 4.4).
Izmed statinov, so farmakokinetične interakcije zdravila Trevaclyn raziskali samo s simvastatinom (glejte poglavje 4.4).
Your total cholesterol is made up mainly of ‘bad' (LDL) and ‘good' (HDL) cholesterol.
Celotni holesterol v glavnem sestavljata "slabi" holesterol (LDL) in "dobri" holesterol (HDL).
• Take Trevaclyn with food.
• Vzemite ga s hrano.
Laropiprant has been shown to be effective in reducing flushing symptoms induced by nicotinic acid.
Pokazalo se je, da laropiprant učinkovito zmanjša simptome zardevanja, ki jih povzroča nikotinska kislina.
In the second study (16 weeks) where acetylsalicylic acid was allowed, patients taking Trevaclyn 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).
V drugi študiji (16 tednov), v kateri je bilo dovoljeno uporabljati acetilsalicilno kislino, so bolniki, ki so prejemali zdravilo Trevaclyn, doživljali zmerno ali izrazitejše zardevanje značilno manj dni na teden kot bolniki, ki so prejemali nikotinsko kislino (pripravek s podaljšanim sproščanjem, uporabljen v 12-tedenski večstopenjski titraciji od 500 mg do 2.000 mg) (p < 0,001).
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
EU/1/08/458/001 14 tablet s prirejenim sproščanjem EU/1/08/458/002 28 tablet s prirejenim sproščanjem EU/1/08/458/003 56 tablet s prirejenim sproščanjem EU/1/08/458/004 84 tablet s prirejenim sproščanjem EU/1/08/458/005 98 tablet s prirejenim sproščanjem EU/1/08/458/006 168 tablet s prirejenim sproščanjem EU/1/08/458/007 196 tablet s prirejenim sproščanjem EU/1/08/458/008 49 x 1 tableta s prirejenim sproščanjem EU/1/08/458/012 196 (2 pakiranji po 98) tablet s prirejenim sproščanjem
HMG-CoA reductase inhibitors: When simvastatin is combined with nicotinic acid, a modest increase in AUC and Cmax of simvastatin acid (the active form of simvastatin) was observed, which may be devoid of clinical relevance.
Zaviralci reduktaze HMG-CoA: Med uporabo simvastatina v kombinaciji z nikotinsko kislino sta se AUC in Cmax simvastatinske kisline (aktivne oblike simvastatina) zmerno zvišali, kar je lahko klinično nepomembno.
Eye disorders: Cystoid macular oedema, toxic amblyopia.
Očesne bolezni: cistoiden edem makule, toksična ambliopija.
In clinical trials, over 5,700 patients received Trevaclyn alone or with an HMG-CoA reductase inhibitor.
V kliničnih preskušanjih je zdravilo Trevaclyn samo ali skupaj z zaviralcem reduktaze HMG-CoA dobivalo več kot 2.500 bolnikov.
Effects of other medicinal products on laropiprant
Učinki drugih zdravil na laropiprant
Cases of overdose have been reported; the maximum dose of Trevaclyn taken was 5,000 mg/100 mg. All patients recovered without sequelae.
Poročali so o primerih prevelikega odmerjanja; največji zaužiti odmerek zdravila Trevaclyn je bil 5.000 mg/100 mg.
This will lower your chance of flushing (redness of the skin, feeling warm, itching, or tingling, particularly in your head, neck, chest and upper back).
Tako bo manjša možnost, da se pojavi zardevanje (pordelost kože, občutek toplote, srbenje ali mravljinčenje, še zlasti v predelu glave, vratu, prsi in zgornjega dela hrbta).
Because nicotinic acid and its metabolites are excreted through the kidneys, Trevaclyn should be used with caution in patients with renal dysfunction.
Nikotinska kislina in njeni presnovki se izločajo skozi ledvice, zato morate pri bolnikih z motenim delovanjem ledvic zdravilo Trevaclyn uporabljati previdno.
Use of Trevaclyn in patients with hepatic or renal insufficiency has not been studied.
Uporaba zdravila Trevaclyn pri bolnikih z jetrno ali ledvično insuficienco ni raziskana.
Contents of the pack and other information
Shranjevanje zdravila Trevaclyn Vsebina pakiranja in dodatne informacije
In three large clinical trials measuring patient-reported flushing symptoms, patients taking Trevaclyn experienced less flushing than those taking nicotinic acid (prolonged-release formulations).
V treh velikih kliničnih preskušanjih, v katerih so ugotavljali simptome zardevanja po navedbi bolnikov, je bilo zardevanja manj med bolniki, ki so prejemali zdravilo Trevaclyn, kot med bolniki, ki so prejemali nikotinsko kislino (pripravek s podaljšanim sproščanjem).
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 Trevaclyn experienced significantly more flushing than patients who continued taking Trevaclyn in terms of number of days per week with moderate or greater flushing, p< 0.001, Figure 2.
Multicentrična, randomizirana, dvojno slepa, s placebom nadzorovana 32-tedenska študija za oceno učinka prenehanja jemanja laropipranta je pokazala, da je bilo pri bolnikih z dislipidemijo, ki so po 20 tednih zdravljenja z zdravilom Trevaclyn prenehali jemati laropiprant, bistveno več zardevanja kot pri bolnikih, ki so nadaljevali z jemanjem zdravila Trevaclyn, kar je bilo izraženo s številom dni v tednu z zmernim ali izrazitejšim zardevanjem, p < 0,001, Slika 2.
Further analysis showed Trevaclyn (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 ).
Kot je pokazala nadaljnja analiza, je sočasno s simvastatinom uporabljen Trevaclyn 2.000 mg/40 mg v primerjavi s samim simvastatinom bistveno zvišal apo A-I (8,6 % oz. 2,3 %) in bistveno znižal Lp(a) (-19,8 % oz. 0,0 %).
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).
Pri zdravih preiskovancih, ki so dobivali zdravilo Trevaclyn, predhodna uporaba 325 mg acetilsalicilne kisline ni dodatno ublažila simptomov zardevanja zaradi nikotinske kisline v primerjavi s samim zdravilom Trevaclyn (glejte poglavje 4.8).
▲ Trevaclyn  nicotinic acid (laropiprant withdrawn at Week 21)
● Trevaclyn ▲ Trevaclyn Æ nikotinska kislina (ukinitev laropipranta v 21. tednu) ○ Placebo
This is characterised by multiple symptoms that may include: angio-oedema, pruritus, erythema, paraesthesia, loss of consciousness, vomiting, urticaria, flushing, dyspnoea, nausea, incontinence of urine and stool, cold sweats, shivering, chills, increased blood pressure, lip swelling, burning sensation, drug eruption, arthralgia, leg swelling, and tachycardia.
Poročali so o (< 1 %) očitni preobčutljivostni reakciji, za katero so značilni različni simptomi, ki lahko vključujejo: angioedem, srbenje, eritem, parestezije, izgubo zavesti, bruhanje, urtikarijo, zardevanje, dispnejo, navzeo, inkontinenco urina in blata, hladno znojenje, drgetanje, mrzlico, zvišan krvni tlak, otekanje ustnic, pekoč občutek, medikamentozen izpuščaj, artralgijo, otekanje nog in tahikardijo.
• you are allergic to nicotinic acid, to laropiprant, or to any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na nikotinsko kislino, laropiprant ali katerokoli sestavino tega zdravila
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.
V štirih z učinkovino ali s placebom kontroliranih kliničnih preskušanjih (N = 4.747, n = 2.548 jih je jemalo zdravilo Trevaclyn) so raziskovalci o zardevanju poročali kot o možno, verjetno ali zagotovo z zdravilom povezanem neželenem učinku pri 12,3 % bolnikov, ki so jemali Trevaclyn.
Caution should be used when Trevaclyn is co-administered with medicinal products metabolised predominantly by UGT2B4 or UGT2B7, for instance zidovudine.
Previdnost je potrebna, če zdravilo Trevaclyn uporabljate hkrati z zdravili, ki se presnavljajo predvsem z UGT2B4 ali UGT2B7, kot je zidovudin.
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.
Izgled zdravila Trevaclyn in vsebina pakiranja Tablete s prirejenim sproščanjem so v obliki kapsul, bele do kremaste barve in imajo na eni strani vtisnjeno oznako "552".
There is no difference in the oral bioavailability of nicotinic acid in men and women receiving Trevaclyn.
Biološka uporabnost peroralne nikotinske kisline se med moškimi in ženskami, ki so dobivali zdravilo Trevaclyn, ni razlikovala.
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.
Zdravilo Trevaclyn je treba uporabljati v kombinaciji z zaviralci reduktaze HMG-CoA (statini), če monoterapija z zaviralcem reduktaze HMG-CoA holesterola ne zniža v zadostni meri.
• See your doctor regularly to check your LDL (bad) and HDL (good) cholesterol levels and your triglyceride level.
• Redno obiskujte zdravnika, da boste preverili raven LDL holesterola (slabi holesterol), HDL holesterola (dobri holesterol) in trigliceridov.
• Your doctor should do a blood test before you start taking Trevaclyn to check how well your liver is working.
• Pred začetkom uporabe zdravila Trevaclyn vas mora zdravnik poslati na preiskavo krvi, da bo preveril delovanje vaših jeter.
• 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.
• Če prehajate z zdravila, ki vsebuje 2.000 mg nikotinske kisline s podaljšanim sproščanjem ali več, vam zdravnik lahko predpiše, da začnete jemati dve tableti zdravila Trevaclyn na dan.
The no-observed-adverse-effect level (NOAEL) was at least 118 times the human exposure based on the AUC of the recommended daily human dose.
Raven brez ugotovljenih neželenih učinkov (NOAEL) je bila vsaj 118-krat tolikšna, kot je (na podlagi AUC) izpostavljenost med uporabo priporočenega dnevnega odmerka pri človeku.
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.
Po peroralni uporabi 2.000 mg nikotinske kisline v obliki dveh tablet nikotinske kisline/laropipranta s prirejenim sproščanjem, zaužitih s hrano, je bila mediana časa do največje koncentracije nikotinske kisline v plazmi (tmax) 4 ure, povprečna površina pod krivuljo plazemske koncentracije v odvisnoti od časa (AUC0-last) približno 58,0 µM·h in povprečna največja koncentracija v plazmi (Cmax) približno 20,2 µM.
Trevaclyn: Use in patients with renal insufficiency has not been studied.
Trevaclyn: Uporaba pri bolnikih z ledvično insuficienco ni raziskana.
• tingling or numbness of the hands or feet
• mravljinčenje in omrtvelost dlani ali stopal
Aluminium/Aluminium blister with push-through lidding containing 7 modified-release tablets.
Aluminijsko/aluminijski pretisni omot s prekritjem, skozi katerega se potisne tableta; omot vsebuje 7 tablet s prirejenim sproščanjem.
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.
Če prehajate z zdravila, ki vsebuje manj kot 2.000 mg nikotinske kisline s podaljšanim sproščanjem, morate na začetku jemati po eno tableto zdravila Trevaclyn na dan.
Nicotinic acid Nicotinic acid is excreted in human breast milk.
Nikotinska kislina Nikotinska kislina se izloča v materino mleko.
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
Laboratorijski izvidi zvišanje ALT in/ali AST (zaporedno, ≥ 3 x ZMN), glukoze na tešče, sečne kisline (glejte spodaj)