FrancophonIA/ELRC3.0 huggingface dataset:
English: Symptoms included fainting, shortness of breath, wheezing or trouble breathing, swelling of the face, lips, tongue, itching or hives on the skin.
Slovenian: Simptomi so zajemali omedlevico, kratko sapo, piskanje ali težko dihanje, otekanje obraza, ustnic, jezika, srbenje ali koprivnico.
English: Rare: elevations in total bilirubin, amylase; reductions in phosphorus and platelet counts (see below)
Slovenian: Redki: zvišanje celokupnega bilirubina, amilaze; znižanje fosforja in števila trombocitov (glejte spodaj)
English: Medicinal product /laboratory test interactions: In urine glucose tests, nicotinic acid may also give false-positive reactions with cupric sulfate solution (Benedict's reagent).
Slovenian: Vpliv zdravila na laboratorijske preiskave: Pri določanju glukoze v urinu lahko nikotinska kislina povzroči lažno pozitivne reakcije z raztopino bakrovega sulfata (Benedictov reagent).
English: Pelzont is not recommended in pregnancy unless clearly necessary.
Slovenian: Nosečnost in dojenje Zdravila Pelzont v nosečnosti ne priporočamo, razen če je nujno potrebno.
English: The medicine comes as a modified-release tablet.
Slovenian: Zdravilo je v obliki tablet s prirejenim sproščanjem.
English: Cholesterol is one of several fats found in your blood.
Slovenian: Holesterol je ena od maščob v krvi.
English: Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly to keep track of your cholesterol and discuss your goals with your doctor.
Slovenian: Redno obiskujte svojega zdravnika, da boste spremljali raven holesterola in se z zdravnikom pogovorili o ciljih zdravljenja.
English: • you have an ulcer in your stomach.
Slovenian: • če imate razjedo na želodcu.
English: Effect on lipids
Slovenian: Učinek na lipide
English: • Your doctor may also want you to periodically have blood tests after you start taking Pelzont, to check how well your liver is working and for other side effects.
Slovenian: • Morda vas bo zdravnik na preiskave krvi napotil tudi med zdravljenjem z zdravilom Pelzont, da bo preveril delovanje vaših jeter in druge neželene učinke.
English: Flushing is most prominent in the head, neck, and upper torso.
Slovenian: Izrazitejše je v predelu glave, vratu in zgornjega dela trupa.
English: However, if you do not take Pelzont for 7 or more days in a row, talk to your doctor before restarting Pelzont.
Slovenian: Če pa se zgodi, da zdravila Pelzont niste vzeli 7 ali več dni zapored, se pred ponovnim začetkom jemanja posvetujte z zdravnikom.
English: • yellowing of the skin and/or eyes (jaundice)
Slovenian: • porumenelosti kože in/ali oči (zlatenici), • mehurčastem izpuščaju.
English: When the blood flow is blocked, the result can be a heart attack or stroke.
Slovenian: Prekinitev dotoka krvi lahko povzroči srčni infarkt ali možgansko kap.
English: (ALT) or aspartate aminotransferase (AST) of ≥ 3 X ULN persist, reduction of dose or withdrawal of Pelzont is recommended.
Slovenian: Če zvišanje vrednosti alanin aminotransferaze (ALT) ali aspartat aminotransferaze (AST) na ≥ 3 x ZMN (zgornja meja normalne vrednosti) vztraja, je priporočljivo zmanjšati odmerek zdravila Pelzont ali pa zdravilo Pelzont prenehati uporabljati.
English: Pelzont 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.
Slovenian: Zdravilo Pelzont je treba uporabljati v kombinaciji z zaviralci reduktaze HMG-CoA (statini), če monoterapija z zaviralcem reduktaze HMG-CoA holesterola ne zniža v zadostni meri.
English: When Pelzont is co-administered with a statin, please refer to the Summary of Product Characteristics for that particular medicinal product.
Slovenian: Če zdravilo Pelzont uporabljate skupaj s statinom, morate upoštevati Povzetek glavnih značilnosti za to zdravilo.
English: The oral bioavailability of nicotinic acid is not altered when it is taken with a high-fat meal.
Slovenian: Biološka uporabnost nikotinske kisline se ne spremeni, če je zaužita z zelo mastnim obrokom.
English: Nicotinic acid: see section 4.4.
Slovenian: Nikotinska kislina: glejte poglavje 4.4.
English: Eye disorders: Cystoid macular oedema, toxic amblyopia.
Slovenian: Očesne bolezni: cistoidni edem makule, toksična ambliopija.
English: These elevations were generally asymptomatic and returned to baseline after discontinuation of therapy or with continued treatment.
Slovenian: Ta zvišanja so bila praviloma nesimptomatska, vrednosti pa so se po prenehanju zdravljenja ali tekom nadaljevanja zdravljenja vrnile na izhodiščne vrednosti.
English: Your cholesterol problem may return.
Slovenian: Nenormalna raven holesterola se lahko ponovi.
English: It is unknown whether laropiprant is excreted in human breast milk.
Slovenian: Ni znano, ali se laropiprant izloča v materino mleko.
English: • cold sweats
Slovenian: • hladno znojenje
English: EU/1/08/460/001 EU/1/08/460/002 EU/1/08/460/003 EU/1/08/460/004 EU/1/08/460/005 EU/1/08/460/006 EU/1/08/460/007 EU/1/08/460/008 EU/1/08/460/009 EU/1/08/460/010
Slovenian: EU/1/08/460/001 EU/1/08/460/002 EU/1/08/460/003 EU/1/08/460/004 EU/1/08/460/005 EU/1/08/460/006 EU/1/08/460/007 EU/1/08/460/008 EU/1/08/460/009 EU/1/08/460/010 EU/1/08/460/011 EU/1/08/460/012 EU/1/08/460/013 EU/1/08/460/014
English: There is no experience with doses of laropiprant above 900 mg in humans.
Slovenian: Izkušenj z odmerki, večjimi od 900 mg laropipranta, pri človeku ni.
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP. Do not store above 30°C.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake EXP/Uporabno do.
English: Acetylsalicylic acid and clopidogrel: In a clinical study in dyslipidaemic patients receiving both acetylsalicylic acid (81 mg) and clopidogrel (75 mg), laropiprant induced transient (4 hours post-dose) inhibition of platelet function in vivo (as evaluated by bleeding time and platelet aggregation studies), but had little effect across the dosing interval.
Slovenian: Acetilsalicilna kislina in klopidogrel: V klinični študiji pri bolnikih z dislipidemijo, ki so prejemali acetilsalicilno kislino (81 mg) in klopidogrel (75 mg), je laropiprant povzročil prehodno (4 ure po odmerku) inhibicijo delovanja trombocitov in vivo (ocenjeno s preiskavo časa krvavitve in agregacije trombocitov), vendar pa je bil njegov vpliv med intervalom odmerjanja majhen.
English: • palpitation (feeling your heartbeat)
Slovenian: • palpitacije (razbijanje srca)
English: Clinical and in vitro studies support the conclusion that laropiprant is a mild to moderate inhibitor of UGT2B4/UGT2B7.
Slovenian: Klinične študije in študije in vitro potrjujejo, da laropiprant blago do zmerno zavira UGT2B4/UGT2B7.
English: Laropiprant was not carcinogenic in 2 year studies in mice and rats at the highest doses tested, which represents at least 218 to 289 times the human exposure based on the AUC of the recommended daily human dose.
Slovenian: Laropiprant ni bil kancerogen v 2-letnih študijah pri miših in podganah v največjih testiranih odmerkih, ki pomenijo vsaj 218- oz. 289-krat tolikšno izpostavljenost, kot je (na podlagi AUC) izpostavljenost med uporabo priporočenega dnevnega odmerka pri človeku.
English: This effect is unlikely to be clinically important as laropiprant did not increase bleeding time when co-administered with clopidogrel throughout the dosing interval.
Slovenian: Malo verjetno je, da bi bil ta učinek klinično pomemben, saj laropiprant v kombinaciji s klopidogrelom tekom uporabe ni podaljšal časa krvavitve.
English: A multicenter, randomized, double-blind, placebo-controlled 32-week study to assess the effects of withdrawal of laropiprant showed that dyslipidaemic patients in whom laropiprant was withdrawn after 20 weeks on Pelzont experienced significantly more flushing than patients who continued taking
Slovenian: 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
English: Other abnormal laboratory values reported were elevations in LDH, fasting glucose, uric acid, total bilirubin, and amylase, and reductions in phosphorus and platelet counts (see section 4.4).
Slovenian: Druge nenormalne laboratorijske vrednosti, o katerih so poročali, so bile zvišanje LDH, glukoze na tešče, sečne kisline, celotnega bilirubina in amilaze ter znižanje fosforja in števila trombocitov (glejte poglavje
English: • Uncontrolled hypothyroidism
Slovenian: • neurejen hipotiroidizem,
English: Therefore, taking aspirin to reduce flushing symptoms is not necessary.
Slovenian: Zato jemanje acetilsalicilne kisline za zmanjšanje zardevanja ni potrebno.
English: In three large clinical trials measuring patient-reported flushing symptoms, patients taking Pelzont experienced less flushing than those taking nicotinic acid (prolonged-release formulations).
Slovenian: V treh velikih kliničnih preskušanjih, v katerih so ugotavljali simptome zardevanja po navedbi bolnikov, je bilo zardevanja manj med bolniki, ki so prejemali zdravilo Pelzont, kot med bolniki, ki so prejemali nikotinsko kislino (pripravek s podaljšanim sproščanjem).
English: Hypromellose (E464) Colloidal anhydrous silica (E551) Sodium stearyl fumarate Hydroxypropylcellulose (E463) Microcrystalline cellulose (E460) Croscarmellose sodium Lactose monohydrate Magnesium stearate
Slovenian: 6.1 Seznam pomožnih snovi hipromeloza (E464) brezvoden koloidni silicijev dioksid (E551) natrijev stearilfumarat hidroksipropilceluloza (E463) mikrokristalna celuloza (E460) natrijev karmelozat, premreženi laktoza monohidrat magnezijev stearat
English: Caution should be used when Pelzont is co-administered with medicinal products metabolised predominantly by UGT2B4 or UGT2B7, for instance zidovudine.
Slovenian: Previdnost je potrebna, če zdravilo Pelzont uporabljate hkrati z zdravili, ki se presnavljajo predvsem z UGT2B4 ali UGT2B7, kot je zidovudin.
English: Because nicotinic acid and its metabolites are excreted through the kidneys, Pelzont should be used with caution in patients with renal dysfunction.
Slovenian: Nikotinska kislina in njeni presnovki se izločajo skozi ledvice, zato morate pri bolnikih z motenim delovanjem ledvic zdravilo Pelzont uporabljati previdno.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Slovenian: C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM Sistem farmakovigilance
English: • you have arterial bleeding.
Slovenian: • če krvavite iz arterije.
English: Elevated plasma TG levels are frequently found in a triad with low HDL-C levels and small LDL particles, as well as in association with non-lipid metabolic risk factors for coronary heart disease (CHD).
Slovenian: Zvišana koncentracija trigliceridov se pogosto pojavi v trojici z nizko koncentracijo hHDL in majhnimi delci LDL, pa tudi skupaj z nelipidnimi presnovnimi dejavniki tveganja za koronarno bolezen srca (KBS).
English: In in vitro studies, nicotinic acid and its metabolites did not inhibit CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4-mediated reactions or UGT1A1-mediated 3-glucuronidation of estradiol.
Slovenian: V študijah in vitro nikotinska kislina in njeni presnovki niso zavrli reakcij, ki potekajo s CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 ali CYP3A4, in tudi ne 3-glukuronidacije estradiola, ki poteka z UGT1A1.
English: The incidence and frequency of moderate or greater flushing in patients treated with Pelzont for the duration of the study decreased.
Slovenian: sta se pojavnost in pogostnost zmernega ali izrazitejšega zardevanja v času študije zmanjšali.
English: There is no difference in the oral bioavailability of nicotinic acid in men and women receiving Pelzont.
Slovenian: Biološka uporabnost peroralne nikotinske kisline se med moškimi in ženskami, ki so dobivali zdravilo Pelzont, ni razlikovala.
English: In in vitro studies, laropiprant did not inhibit CYP1A2, CYP2B6, CYP2C19, CYP2D6, or CYP2E1-mediated reactions.
Slovenian: V študijah in vitro laropiprant ni zaviral reakcij, ki potekajo s CYP1A2, CYP2B6, CYP2C19, CYP2D6 ali CYP2E1.
English: In healthy subjects receiving Pelzont, pretreatment with acetylsalicylic acid 325 mg had no additional beneficial effects in reducing nicotinic acid-induced flushing symptoms compared to Pelzont alone (see section 4.8).
Slovenian: Pri zdravih preiskovancih, ki so dobivali zdravilo Pelzont, predhodna uporaba 325 mg acetilsalicilne kisline ni dodatno ublažila simptomov zardevanja zaradi nikotinske kisline v primerjavi s samim zdravilom Pelzont (glejte poglavje 4.8).
English: • medicines used to lower cholesterol called ‘bile acid sequestrants', such as colestyramine.
Slovenian: • zdravila za zniževanje holesterola, ki jih imenujemo "adsorbenti žolčnih kislin", npr. holestiramin.
English: The oxidative metabolism of laropiprant is catalysed primarily by CYP3A4, whereas several UGT isoforms (1A1, 1A3, 1A9 and 2B7) catalysed the acyl glucuronidation.
Slovenian: Oksidativno presnovo laropipranta katalizira predvsem CYP3A4, acilglukuronidacijo pa več izooblik UGT (1A1, 1A3, 1A9 in 2B7).
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Pelzont Vsebina pakiranja in dodatne informacije
English: Nicotinic acid is predominantly excreted in the urine as metabolites.
Slovenian: Nikotinska kislina se v glavnem izloči v urinu v obliki presnovkov.
English: Laropiprant: Administration of laropiprant 40 mg in non-dialysed patients with severe renal insufficiency resulted in no clinically meaningful change in the AUC and Cmax of laropiprant, compared to healthy control subjects.
Slovenian: Laropiprant: Pri bolnikih s hudo ledvično insuficienco, ki niso bili na dializi, uporaba 40 mg laropipranta ni klinično pomembno spremenila AUC in Cmax laropipranta v primerjavi z zdravimi kontrolnimi osebami.
English: • The other ingredients are: hypromellose (E464), colloidal anhydrous silica (E551), sodium stearyl fumarate, hydroxypropylcellulose (E463), microcrystalline cellulose (E460), croscarmellose sodium, lactose monohydrate, and magnesium stearate.
Slovenian: • Pomožne snovi so: hipromeloza (E464), brezvodni koloidni silicijev dioksid (E551), natrijev stearilfumarat, hidroksipropilceluloza (E463), mikrokristalna celuloza (E460), premreženi natrijev karmelozat, laktoza monohidrat in magnezijev stearat.
English: Not known: vesicular or vesiculobullous rash
Slovenian: Neznana: vezikularni ali vezikulobulozni izpuščaj
English: Patients who develop increased transaminase levels should be monitored until the abnormalities have resolved.
Slovenian: Če se transaminaze zvišajo, morate bolnika spremljati, dokler nepravilnosti ne izginejo.
English: Laropiprant has been shown to be effective in reducing flushing symptoms induced by nicotinic acid.
Slovenian: Farmakodinamični učinki Pokazalo se je, da laropiprant učinkovito zmanjša simptome zardevanja, ki jih povzroča nikotinska kislina.
English: Because 1'-hydroxymidazolam is an active metabolite, the sedative effect of midazolam may be increased and caution should be used when laropiprant is co-administered with midazolam.
Slovenian: Ker je 1'-hidroksimidazolam aktiven presnovek, se lahko sedativni učinek midazolama poveča.
English: The first pathway results in the formation of nicotinamide adenine dinucleotide (NAD) and nicotinamide.
Slovenian: Po prvi poti nastaneta nikotinamidadenindinukleotid (NAD) in nikotinamid.
English: CYP3A4 Inhibitor: Clarithromycin (a potent inhibitor of CYP3A4 and P-gp) did not have a clinically meaningful effect on the pharmacokinetics of laropiprant.
Slovenian: Učinki drugih zdravil na laropiprant Zaviralec CYP3A4: Klaritromicin (močan zaviralec CYP3A4 in P-gp) ni klinično pomembno vplival na farmakokinetiko laropipranta.
English: Based on these data, laropiprant is not expected to cause interactions with substrates of CYP isozymes 3A4, 2C9, 2C8 and human P-glycoprotein (P-gp).
Slovenian: Glede na te podatke ni pričakovati medsebojnega delovanja laropipranta s substrati izoencimov 3A4, 2C9 in 2C8
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (for PVC/Aclar blister)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla (s PVC/Aclar pretisnimi omoti)
English: In the second pathway, glycine is conjugated with nicotinic acid to form nicotinuric acid (NUA).
Slovenian: Po drugi poti se glicin konjugira z nikotinsko kislino in nastane nikotinurična kislina.
English: Haematologic effects
Slovenian: Hematološki učinki
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 Pelzont a day.
Slovenian: • 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 Pelzont na dan.
English: Effects of nicotinic acid on other medicinal products Antihypertensive therapy: Nicotinic acid may potentiate the effects of ganglionic blocking agents and vasoactive medicinal products such as nitrates, calcium channel blockers, and adrenergic receptor blocking agents, resulting in postural hypotension.
Slovenian: Antihipertenzivna zdravila: Nikotinska kislina lahko poveča učinke ganglijskih zaviralcev in vazoaktivnih zdravil, kot so nitrati, zaviralci kalcijevih kanalov ali adrenergični zaviralci, in tako povzroči posturalno hipotenzijo.
English: Further analysis showed Pelzont (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 ).
Slovenian: Kot je pokazala nadaljnja analiza, je sočasno s simvastatinom uporabljeno zdravilo Pelzont 2.000 mg/40 mg v primerjavi s samim simvastatinom bistveno zvišalo apo A-I (8,6 % oz. 2,3 %) in bistveno znižalo Lp(a) (-19,8 % oz. 0,0 %).
English: Uncommon: gout Rare: impaired glucose tolerance
Slovenian: Presnovne in prehranske motnje Občasni: protin Redki: motena toleranca za glukozo
English: The combination has not been tested in reproductive toxicity studies.
Slovenian: Vpliv kombinacije na sposobnost razmnoževanja v študijah ni bil raziskan.
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: Dodatni neželeni učinki, o katerih so poročali pri drugih zdravilih z nikotinsko kislino Dodatni neželeni učinki, o katerih so poročali v obdobju trženja ali v kliničnih preskušanjih z drugimi zdravili z nikotinsko kislino (z ali brez statina) vključujejo:
English: Reproduction toxicity studies showed slight treatment-related decreases in mean maternal weight gain and foetal body weight, slight increases in pup mortality, and increased incidence of supernumerary rib and incomplete ossification of the sternebra in the foetus were observed in rats at systemic exposure levels at least 513 times the human exposure based on the AUC of the recommended daily human dose.
Slovenian: Študije reproduktivne toksičnosti so pri podganah pokazale majhno z zdravilom povezano zmanjšanje povprečnega povečanja telesne mase samice matere in plodu, rahlo povečanje umrljivosti mladičev ter večjo incidenco nadštevilnih reber in nepopolnega zakostenevanja sternebre pri plodu pri sistemski izpostavljenosti, ki je bila vsaj 513-krat tolikšna, kot je (na podlagi AUC) izpostavljenost med uporabo priporočenega dnevnega odmerka pri človeku.
English: The hepatocellular centrilobular hypertrophy was consistent with rodent specific enzyme induction.
Slovenian: Centrilobularna hipertrofija jetrnih celic se je skladala z indukcijo encimov, specifično za glodalce.
English: There are no data from the use of laropiprant in pregnant women.
Slovenian: O uporabi laropipranta pri nosečnicah ni podatkov.
English: Acetylsalicylic acid: In a clinical study, concomitant administration of laropiprant with acetylsalicylic acid did not have an effect on collagen-induced platelet aggregation or on bleeding time compared to treatment with acetylsalicylic acid alone (see section 5.1).
Slovenian: Acetilsalicilna kislina: V klinični študiji sočasna uporaba laropipranta in acetilsalicilne kisline ni vplivala na agregacijo trombocitov, izzvano s kolagenom, ali na čas krvavitve v primerjavi z uporabo same acetilsalicilne kisline (glejte poglavje 5.1).
English: The pharmacokinetics of laropiprant are linear, displaying approximately dose-proportional increases in AUC and Cmax and no evidence of time-dependent clearance.
Slovenian: Povečevanje AUC in Cmax je približno sorazmerno odmerku in znakov časovno odvisnega očistka ni.
English: The tablets should be taken whole, with food, in the evening or at bedtime.
Slovenian: Način uporabe Tablete Pelzont mora bolnik vzeti cele, s hrano, zvečer ali pred spanjem.
English: The starting dose is one modified-release tablet (1,000 mg nicotinic acid/20 mg laropiprant) once a day.
Slovenian: Začetni odmerek je ena tableta s prirejenim sproščanjem (1.000 mg nikotinske kisline/20 mg laropipranta) enkrat na dan.
English: Pelzont 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: Pelzont 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: Laropiprant was not mutagenic or clastogenic in a series of genetic toxicology studies.
Slovenian: Laropiprant v vrsti genetskih toksikoloških študij ni bi ne mutagen ne klastogen.
English: Like LDL, cholesterol-enriched triglyceride-rich lipoproteins, including VLDL, intermediate-density lipoproteins (IDL), and remnants, can also promote atherosclerosis.
Slovenian: Prav tako kot LDL lahko aterosklerozo pospešujejo tudi s holesterolom obogateni in s trigliceridi bogati lipoproteini, vključno z VLDL, lipoproteini srednje gostote (IDL) in ostanki.
English: Pelzont: Use in patients with renal insufficiency has not been studied.
Slovenian: Pelzont: Uporaba pri bolnikih z ledvično insuficienco ni raziskana.
English: How Pelzont Works
Slovenian: Kako deluje zdravilo Pelzont
English: Fertility Animal studies are insufficient with respect to impairment on fertility (see section 5.3).
Slovenian: Plodnost Ni dovolj študij na živalih o vplivu zdravila na plodnost (glejte poglavje 5.3).
English: ●Pelzont (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: ● Pelzont (1.000 mg/20 mg do 2.000 mg/40 mg 5. teden)
English: To preserve the modified-release properties, the tablets must not be split, broken, crushed, or chewed before swallowing.
Slovenian: Tablet s prirejenim sproščanjem se pred zaužitjem ne sme prelomiti, zdrobiti ali zgristi.
English: Opaque PVC/Aclar blister with push-through aluminium lidding containing 14 modified-release tablets.
Slovenian: Neprozoren pretisni omot iz PVC/Aclarja z aluminijskim prekritjem, skozi katerega se potisne tableta; omot vsebuje 14 tablet s prirejenim sproščanjem.
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 AUC0-∞ of approximately 13 μM·hr, and a mean Cmax of approximately 1.6 μM.
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.