FrancophonIA/ELRC3.0 huggingface dataset:
English: Laropiprant is metabolised primarily via acyl glucuronidation, with a smaller component of oxidative metabolism, followed by excretion of the glucuronide into faeces (via bile) and urine.
Slovenian: Laropiprant se presnovi predvsem z acilglukuronidacijo, z manjšim deležem oksidativne presnove; temu sledi izločanje glukuronida v blatu (z žolčem) in urinu.
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).
Slovenian: Trevaclyn 2.000 mg/40 mg, uporabljen sočasno s simvastatinom, je v primerjavi s samim simvastatinom ali samim zdravilom Trevaclyn 2.000 mg/40 mg v 12 tednih bistveno znižal hLDL (-47,9 % oz. -37,0 % oz. -17,0 %), trigliceride (-33,3 % oz. -14,7 % oz. -21,6 %), apo B (-41,0 % oz. -28,8 % oz. -17,1 %) in Ch (-29,6 % oz. -24,9 % oz. -9,1 %) kot tudi razmerje hLDL:hHDL (-57,1 % oz. -39,8 % oz. -31,2 %), ne-HDL-holesterol (-45,8 % oz. -33,4 % oz. -18,1 %) in razmerje Ch:hHDL (-43,0 % oz. -28,0 % oz. -24,9 %) ter bistveno zvišal hHDL (27,5 % oz. 6,0 % oz. 23,4 %).
English: Do not take Trevaclyn if
Slovenian: Ne jemljite zdravila Trevaclyn:
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).
Slovenian: V multicentrični, dvojno slepi 12-tedenski faktorski študiji je 4-tedenska uporaba zdravila Trevaclyn 1.000 mg/20 mg skupaj s simvastatinom v primerjavi s simvastatinom samim oz. z zdravilom Trevaclyn 1.000 mg/20 mg samim bistveno znižala hLDL (-44,2 %, -37,4 % oz. -8,2 %), trigliceride (-25,8 %, -15,7 % oz. -18,7 %), Ch (-27,9 %, -25,8 % oz. -4,9 %) in bistveno zvišala hHDL (19,2 %, 4,2 % oz. 12,5 %).
English: Capsule-shaped, white to off-white tablet, with “552” debossed on one side.
Slovenian: FARMACEVTSKA OBLIKA tableta s prirejenim sproščanjem tablete v obliki kapsule in bele do kremaste barve z vtisnjeno oznako "552" na eni strani
English: Trevaclyn was consistently efficacious across all prespecified patient subpopulations defined by race, gender, baseline LDL-C, HDL-C and TG levels, age and diabetes status.
Slovenian: Trevaclyn je bil enako učinkovit v vseh skupinah populacije bolnikov, ne glede na raso, spol, izhodiščno koncentracijo hLDL, hHDL in trigliceridov, ali glede na starost, pa tudi v skupini sladkornih bolnikov.
English: If muscle pain, weakness or cramps occur while a patient is receiving Trevaclyn with a statin, their CK levels should be measured.
Slovenian: Če se med jemanjem zdravila Trevaclyn skupaj s statinom pojavijo bolečine v mišicah, oslabelost mišic ali mišični krči, je treba bolniku izmeriti raven CK.
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 Trevaclyn with or without a statin.
Slovenian: V kontroliranih kliničnih študijah je bila pri bolnikih, ki so prejemali zdravilo Trevaclyn (s statinom ali brez njega), incidenca klinično pomembnih zvišanj serumskih transaminaz (ALT in/ali AST ≥ 3 x ZMN, zaporedno) 1,0 %.
English: Each tablet contains 1000 mg nicotinic acid and 20 mg laropiprant.
Slovenian: Vsaka tableta vsebuje 1000 mg nikotinske kisline in 20 mg laropipranta.
English: Trevaclyn 1,000 mg/20 mg modified-release tablets nicotinic acid/laropiprant
Slovenian: Trevaclyn 1.000 mg/20 mg tablete s prirejenim sproščanjem nikotinska kislina/laropiprant
English: Laropiprant is eliminated primarily via acyl glucuronidation, followed by excretion of the glucuronide in faeces (via bile) and urine.
Slovenian: Laropiprant se odstrani predvsem z acilglukuronidacijo, sledi pa izločanje glukuronida v blatu (z žolčem) in urinu.
English: Hepatic insufficiency Trevaclyn: Use in patients with hepatic insufficiency has not been studied.
Slovenian: Jetrna insuficienca Trevaclyn: Uporaba pri bolnikih z jetrno insuficienco ni raziskana.
English: Multi-pack containing 196 (2 packs of 98) modified-release tablets 49 x 1 modified-release tablets
Slovenian: Multi pakiranje po 196 (2 pakiranji po 98) tablet s prirejenim sproščanjem 49 x 1 tableta s prirejenim sproščanjem
English: How Trevaclyn Works
Slovenian: Kako deluje zdravilo Trevaclyn
English: • nicotinic acid, a lipid modifying medicine, and
Slovenian: • nikotinsko kislino, ki je zdravilo z vplivom na maščobe (lipide) in
English: The incidence and frequency of moderate or greater flushing in patients treated with Trevaclyn for the duration of the study decreased.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Trevaclyn, sta se pojavnost in pogostnost zmernega ali izrazitejšega zardevanja v času študije zmanjšali.
English: Physicians should consider the nicotinic acid intake from vitamins and nutritional supplements when prescribing Trevaclyn.
Slovenian: Pri predpisovanju zdravila Trevaclyn morate upoštevati vnos nikotinske kisline z vitamini in prehranskimi dopolnili.
English: No studies in lactating animals have been conducted with Trevaclyn.
Slovenian: Na doječih živalih študije z zdravilom Trevaclyn niso bile izvedene.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (for Alu/Alu blister)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla (z Alu/alu pretisnimi omoti)
English: How to take Trevaclyn
Slovenian: Kako jemati zdravilo Trevaclyn
English: Therefore, 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).
Slovenian: Zato je pri zdravljenju kitajskih bolnikov, ki jemljejo zdravilo Trevaclyn skupaj s simvastatinom ali z ezetimibom/simvastatinom (zlasti pri odmerkih simvastatina 40 mg ali več) potrebna previdnost.
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).
Slovenian: Med bolniki, ki so nadaljevali sodelovanje v prvi študiji (24 tednov), se je pogostnost zmernega ali izrazitejšega zardevanja med tistimi, ki so prejemali zdravilo Trevaclyn, zmanjšala in se je približala tisti pri bolnikih, ki so dobivali placebo (glejte sliko 1).
English: 14 modified-release tablets 28 modified-release tablets 56 modified-release tablets 168 modified-release tablets 32 x 1modified-release tablets
Slovenian: 14 tablet s prirejenim sproščanjem 28 tablet s prirejenim sproščanjem 56 tablet s prirejenim sproščanjem 168 tablet s prirejenim sproščanjem 32 x 1 tableta s prirejenim sproščanjem
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).
Slovenian: Tako kot pri drugih zdravilih z nikotinsko kislino so v kontroliranih kliničnih študijah z zdravilom Trevaclyn (2.000 mg/40 mg) poročali o zvišanju glukoze na tešče (mediana vrednost zvišanja je bila približno 4 mg/dl) in sečne kisline (povprečna sprememba glede na izhodišče +14,7 %) ter zmanjšanju števila trombocitov (povprečna sprememba glede na izhodišče -14,0 %) (glejte poglavje 4.4).
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.
Slovenian: Ker je tveganje za miopatijo pri statinih odvisno od odmerka, pri kitajskih bolnikih ne priporočamo uporabe zdravila Trevaclyn skupaj s simvastatinom 80 mg ali z ezetimibom/simvastatinom 10/80 mg. Ni znano, ali je tveganje za miopatijo povečano tudi pri drugih azijskih bolnikih, zdravljenih z zdravilom Trevaclyn in s simvastatinom ali z ezetimibom/simvastatinom.
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)
Slovenian: ● Trevaclyn (1.000 mg/20 mg do 2.000 mg/40 mg 5. teden) ▲Nikotinska kislina (s podaljšanim sproščanjem, 1.000 mg do 2.000 mg 5. teden) ○ Placebo * Vključuje bolnike z zmernimi, hudimi ali izredno hudimi simptomi zardevanja † Povečanje odmerka 5. teden
English: 168 modified-release tablets
Slovenian: 168 tablet s prirejenim sproščanjem
English: • rapid heart rate.
Slovenian: • hitro bitje srca
English: Rare: elevations in total bilirubin, amylase; reductions in phosphorus and platelet counts (see below)
Slovenian: pogosti zvišanje CK (≥ 10 x ZMN), celotnega bilirubina, znižanje fosforja in števila trombocitov (glejte spodaj)
English: Physicians contemplating combined therapy with statins and Trevaclyn 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.
Slovenian: Poleg tega morate bolnika natančno spremljati glede mišičnih bolečin, občutljivosti ali šibkosti mišic, še posebej v prvih mesecih zdravljenja in ob povečanju kateregakoli zdravila.
English: 196 modified-release tablets
Slovenian: 196 tablet s prirejenim sproščanjem
English: The name of your medicine is Trevaclyn.
Slovenian: Vaše zdravilo se imenuje Trevaclyn.
English: Acetylsalicylic acid provides no additional reduction of flushing beyond that achieved by Trevaclyn.
Slovenian: Acetilsalicilna kislina zardevanja ne zmanjša nič bolj, kot ga že zdravilo Trevaclyn.
English: • Avoid drinking alcohol or hot drinks or eating spicy foods near the time you take your dose of Trevaclyn.
Slovenian: • Ne pijte alkohola ali vročih pijač in ne jejte začinjene hrane malo pred zaužitjem odmerka zdravila Trevaclyn ali kmalu po njem.
English: Therefore, patients switching from immediate-release nicotinic acid to Trevaclyn should be initiated at the 1,000 mg/20 mg dose.
Slovenian: Pri bolnikih, ki preidejo na zdravilo Trevaclyn z nikotinske kisline s takojšnjim sproščanjem, morate zdravljenje začeti z odmerkom 1.000 mg/20 mg.
English: Laropiprant was not teratogenic in rats or in rabbits at systemic exposure levels at least 153 and 438 times the human exposure based on the AUC of the recommended daily human dose.
Slovenian: Laropiprant pri podganah oz. kuncih ni bil teratogen pri sistemski izpostavljenosti, ki je bila vsaj 153- oz. 438-krat tolikšna, kot je (na podlagi AUC) izpostavljenost med uporabo priporočenega dnevnega odmerka pri človeku.
English: Patients receiving Trevaclyn 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.
Slovenian: Povedati jim je treba, da lahko traja dalj časa kot običajno, da se krvavitev ustavi, ter da morajo svojemu zdravniku poročati kakršnokoli neobičajno krvavitev (mesto ali trajanje).
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).
Slovenian: Pri zdravljenju kitajskih bolnikov, ki jemljejo zdravilo Trevaclyn skupaj s simvastatinom ali z ezetimibom/simvastatinom (zlasti pri odmerkih simvastatina 40 mg ali več), je potrebna previdnost.
English: Uncommon: palpitations Rare: atrial fibrillation and other cardiac arrhythmias; tachycardia
Slovenian: Srčne bolezni: atrijska fibrilacija in druge motnje srčnega ritma, palpitacije, tahikardija.
English: Opaque PVC/Aclar blister with push-through aluminium lidding in pack sizes of 14, 28, 56, 84, 98, 168, 196 modified-release tablets, multi-packs containing 196 (2 packs of 98) modified-release tablets and 49 x 1 modified-release tablets in perforated unit dose blister.
Slovenian: Neprozoren pretisni omot iz PVC/Aclarja z aluminijskim prekritjem, skozi katerega se potisne tableta, v pakiranjih s 14, 28, 56, 84, 98, 168, 196 tabletami s prirejenim sproščanjem, multi pakiranje s 196 (2 pakiranji po 98) tabletami s prirejenim sproščanjem in z 49 x 1 tableto s prirejenim sproščanjem v perforiranem pretisnem omotu za enkratni odmerek.
English: In these studies, the percentage of patients taking Trevaclyn, 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.
Slovenian: Zaradi kateregakoli od simptomov zardevanja (rdečica, toplota, srbenje in mravljinčenje) je zdravilo Trevaclyn v teh študijah nehalo jemati 7,2 % bolnikov, nikotinsko kislino (skupno vse pripravke s podaljšanim delovanjem) 16,6 % bolnikov in placebo/simvastatin 0,4 % bolnikov.
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).
Slovenian: Tako kot druga zdravila z nikotinsko kislino je bilo tudi zdravilo Trevaclyn (2.000 mg/40 mg) povezano z majhnim zvišanjem koncentracije sečne kisline (glejte poglavje 4.8).
English: The rate and extent of absorption are not altered with a high-fat meal.
Slovenian: Hitrost in obseg absorpcije se z zelo mastnim
English: EU/1/08/458/014 32 x 1modified-release tablets
Slovenian: EU/1/08/458/010 28 tablet s prirejenim sproščanjem
English: In addition, one or more of the following symptoms have been reported as part of an allergic reaction to Trevaclyn.
Slovenian: Občasni (lahko se pojavijo pri največ 1 od 100 bolnikov) Kot del alergijske reakcije na zdravilo Trevaclyn so poročali še o enem ali večih od naslednjih simptomov:
English: Common: erythema; pruritus; rash; urticaria Uncommon: dry skin; macular rash Rare: acanthosis nigricans; hyperpigmentation; sweating (night or cold sweat)
Slovenian: Bolezni kože in podkožja: acanthosis nigricans, suha koža, hiperpigmentacija, makularen izpuščaj, znojenje (ponoči ali hladno znojenje), vezikularni ali vezikulobulozni izpuščaj.
English: Very common: flushing Uncommon: hypotension Rare: orthostatic hypotension
Slovenian: Žilne bolezni: hipotenzija, ortostatska hipotenzija.
English: • dry skin
Slovenian: • otekanje nog
English: Aluminium/Aluminium blister with push-through lidding in pack sizes of 14, 28, 56, 168 modified-release tablets and 32 x 1 modified-release tablets in perforated unit dose blister.
Slovenian: Aluminijsko/aluminijski pretisni omot s prekritjem, skozi katerega se potisne tableta, v pakiranjih s 14, 28, 56, 168 tabletami s prirejenim sproščanjem ter z 32 x 1 tableto s prirejenim sproščanjem v perforiranem pretisnem omotu za enkratni odmerek.
English: Studies in animals have shown foetal developmental toxicity at high doses of nicotinic acid (see section 5.3).
Slovenian: Študije na živalih so pokazale škodljive učinke na razvoj ploda pri velikih odmerkih nikotinske kisline (glejte poglavje
English: Nicotinic acid For an overdose of nicotinic acid, supportive measures should be employed.
Slovenian: Nikotinska kislina V primeru prevelikega odmerjanja nikotinske kisline je treba uporabiti podporne ukrepe.
English: However, nicotinic acid a component of Trevaclyn does pass into breast milk.
Slovenian: da v materino mleko prehaja nikotinska kislina, sestavina zdravila Trevaclyn.
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).
Slovenian: Tako kot druga zdravila z nikotinsko kislino je bilo tudi zdravilo Trevaclyn (2.000 mg/40 mg) povezano z majhnim zmanjšanjem števila trombocitov (glejte poglavje 4.8).
English: Pack sizes of 14, 28, 56; 168 modified-release tablets and 32 x 1modified-release tablets in a perforated unit dose blister.
Slovenian: Velikosti pakiranj: 14, 28, 56, 168 tablet s prirejenim sproščanjem ter 32 x 1 tableta s prirejenim sproščanjem v perforiranem pretisnem omotu za enkratni odmerek.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified-release tablet contains 1,000 mg of nicotinic acid and 20 mg of laropiprant.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta s prirejenim sproščanjem vsebuje 1.000 mg nikotinske kisline in 20 mg laropipranta.
English: As with other nicotinic acid medicinal products, Trevaclyn was associated with small decreases in phosphorus levels.
Slovenian: Tako kot druga zdravila z nikotinsko kislino je bilo tudi zdravilo Trevaclyn povezano z manjšim zmanjšanjem koncentracije fosforja, zato morate bolnike s tveganjem za hipofosfatemijo skrbno spremljati.
English: AUC0-∞ of approximately 13 μM·hr, and a mean Cmax of approximately 1.6 μM.
Slovenian: AUC se poveča približno 2,8-krat in Cmax približno 2,2-krat.
English: Diet and other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with Trevaclyn.
Slovenian: Med zdravljenjem z zdravilom Trevaclyn mora bolnik še naprej upoštevati dieto in druge nefarmakološke ukrepe zdravljenja (npr. telesno dejavnost, zmanjšanje telesne mase).
English: Patients switching from less than 2,000 mg of prolonged-release nicotinic acid should initiate therapy at the starting dose of 1,000 mg/20 mg and advance to the 2,000 mg/40 mg maintenance dose after four weeks.
Slovenian: Če pa je jemal manj kot 2.000 mg nikotinske kisline s podaljšanim sproščanjem, mora zdravljenje z zdravilom Trevaclyn začeti z odmerkom 1.000 mg/20 mg in po 4 tednih preiti na vzdrževalni odmerek 2.000 mg/40 mg.
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:
Slovenian: Izkušnje iz obdobja trženja zdravila in ostale izkušnje iz kliničnih preskušanj Dodatni neželeni učinki, o katerih so z neznano pogostnostjo poročali v obdobju trženja zdravila Trevaclyn ali drugih zdravil z nikotinsko kislino (z ali brez statina) ali v kliničnih preskušanjih z zdravilom Trevaclyn (pri < 1 % bolnikov) ali z drugimi zdravili z nikotinsko kislinsko (z ali brez statina) vključujejo:
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.
Slovenian: Če pa zdravila Trevaclyn ne vzame 7 ali več dni zapored, ga mora znova začeti jemati v odmerku 1.000 mg/20 mg 1 teden.
English: Talk with your doctor before taking Trevaclyn if:
Slovenian: Preden vzamete zdravilo Trevaclyn, se posvetujte z zdravnikom:
English: 84 modified-release tablets
Slovenian: 84 tablet s prirejenim sproščanjem
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Trevaclyn.
Slovenian: Če niste prepričani, ali kaj od naštetega velja za vas, se, preden vzamete zdravilo Trevaclyn, posvetujte z zdravnikom ali s farmacevtom.
English: Merck Sharp & Dohme s.r.o.
Slovenian: Česká republika Merck Sharp & Dohme s.r.o.
English: Trevaclyn contains lactose.
Slovenian: Zdravilo Trevaclyn vsebuje laktozo.
English: Uncommon: insomnia Rare: anxiety
Slovenian: Psihiatrične motnje: anksioznost, nespečnost.
English: Trevaclyn contains lactose
Slovenian: Zdravilo Trevaclyn vsebuje laktozo
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
Slovenian: Po peroralni uporabi 40 mg laropipranta v dveh tabletah nikotinske kisline/laropipranta s prirejenim sproščanjem, zaužitih s hrano, se laropiprant hitro absorbira; mediana tmax je 1 uro, povprečna AUC0-∞ približno 13 µM·h in povprečna Cmax približno 1,6 µM.
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.
Slovenian: Če bolnik preide na zdravilo Trevaclyn s pripravka nikotinske kisline s podaljšanim sproščanjem, ki ga je jemal v odmerku 2.000 mg ali več, lahko zdravilo Trevaclyn začne jemati v odmerku 2.000 mg/40 mg.
English: • migraine
Slovenian: • glavobol
English: 98 modified-release tablets
Slovenian: 98 tablet s prirejenim sproščanjem
English: NAME OF THE MEDICINAL PRODUCT Trevaclyn 1,000 mg/20 mg modified-release tablets.
Slovenian: IME ZDRAVILA Trevaclyn 1.000 mg/20 mg tablete s prirejenim sproščanjem
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.
Slovenian: • Da zmanjšate možnost zardevanja, v času zaužitja zdravila Trevaclyn (ter malo pred tem in po tem) ne pijte alkohola ali vročih pijač in ne jejte začinjene hrane.
English: Some people get dizzy after taking Trevaclyn.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Nekateri ljudje po zaužitju zdravila Trevaclyn postanejo omotični.
English: Respiratory, thoracic, and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora: dispneja.
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 Trevaclyn.
Slovenian: V času zaužitja zdravila Trevaclyn se je treba izogibati pitju alkohola, vročih pijač ali uživanju začinjene hrane, ker to lahko poveča zardevanje.
English: • palpitation (feeling your heartbeat)
Slovenian: • siljenje na bruhanje (slabost v želodcu)
English: The mean absolute bioavailability of laropiprant is approximately 71 % following a 40 mg dose when administered as two modified-release tablets of nicotinic acid/laropiprant after an overnight fast.
Slovenian: Povprečna absolutna biološka uporabnost laropipranta po uporabi 40 mg odmerka (v obliki dveh tablet nikotinske kisline/laropipranta s prirejenim sproščanjem na tešče po noči brez hrane) je približno
English: • hives
Slovenian: • driska
English: How to store Trevaclyn
Slovenian: Shranjevanje zdravila Trevaclyn
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).
Slovenian: Zato je zdravilo Trevaclyn priporočljivo zaužiti več kot 1 uro pred izmenjevalci žolčnih kislin ali več kot 4 ure po njih (glejte poglavje 4.5).
English: cora.greece.gragcm@merck.com
Slovenian: Τηλ: +3 0210 98 97 300 cora.greece.gragcm@merck.com
English: If you are not sure, talk to your doctor or pharmacist before taking Trevaclyn.
Slovenian: Če ste negotovi, se posvetujte s svojim zdravnikom ali s farmacevtom.
English: • weakness
Slovenian: • omotica
English: Uncommon: myalgia Rare: muscular weakness
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva: šibkost mišic, mialgija.
English: Trevaclyn to two tablets a day.
Slovenian: Po 4 tednih vam zdravnik lahko odmerek poveča na dve tableti zdravila Trevaclyn na dan.