FrancophonIA/ELRC3.0 huggingface dataset:
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 Pelzont and simvastatin 40 mg.
Slovenian: V vmesni analizi trenutno potekajoče preživetvene študije je neodvisen odbor za spremljanje varnosti odkril višjo pojavnost miopatije pri kitajskih bolnikih, ki so jemali zdravilo Pelzont in simvastatin 40 mg,
English: Pelzont is used in addition to diet and exercise in adult patients with primary hypercholesterolaemia or mixed dyslipidaemia:
Slovenian: Zdravilo Pelzont se uporablja poleg diete in telesne vadbe pri odraslih bolnikih s primarno hiperholesterolemijo ali z mešano dislipidemijo:
English: Pelzont has not been studied in children and adolescents who are under 18 years of age.
Slovenian: Zdravilo Pelzont ni raziskano pri otrocih in mladostnikih, mlajših od 18 let.
English: The Coronary Drug Project, a five year study completed in 1975, showed that nicotinic acid had a statistically significant benefit in decreasing nonfatal, recurrent myocardial infarctions (MI) in men 30 to 64 years old with a history of MI.
Slovenian: Pet-letna študija Coronary Drug Project, ki se je končala leta 1975, je pokazala, da nikotinska kislina statistično značilno pripomore k zmanjšanju števila neusodnih ponovnih miokardnih infarktov (MI) pri moških od 30. do 64. leta starosti z anamnezo MI.
English: • If you take more than you should, talk to a doctor or pharmacist straight away.
Slovenian: • Če vzamete več zdravila, kot bi smeli, se morate takoj posvetovati z zdravnikom ali s farmacevtom.
English: In a pool of four active- or placebo-controlled clinical trials (N=4,747, n=2,548 taking Pelzont), flushing was reported in 12.3 % of patients taking Pelzont.
Slovenian: V štirih z učinkovino ali s placebom kontroliranih kliničnih preskušanjih (N = 4.747, n = 2.548 jih je jemalo zdravilo Pelzont) so o zardevanju poročali pri 12,3 % bolnikov, ki so jemali Pelzont.
English: • to raise levels of ‘good' cholesterol (HDL cholesterol) and apo A-I (a part of HDL).
Slovenian: • zvišanje "dobrega" holesterola (HDL holesterola) in apo A-I (ki je del HDL).
English: Transaminase elevations were reversible upon discontinuation of therapy.
Slovenian: Zvišanja transaminaz so bila po prenehanju uporabe zdravila reverzibilna.
English: Do not take Pelzont if any of the above apply to you.
Slovenian: Ne vzemite zdravila Pelzont, če kaj od naštetega velja za vas.
English: Other medicines and Pelzont
Slovenian: Druga zdravila in zdravilo Pelzont
English: As with other nicotinic acid medicinal products, caution should be used when Pelzont 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.
Slovenian: Tako kot velja za druga zdravila z nikotinsko kislino, je tudi pri zdravilu Pelzont 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.
English: It can be used as monotherapy only in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated.
Slovenian: Kot monoterapija se lahko uporabi samo pri bolnikih, za katere zaviralci reduktaze HMG-CoA niso primerni ali jih ne prenašajo.
English: Pelzont should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease.
Slovenian: Zdravilo Pelzont morate previdno uporabljati pri bolnikih, ki uživajo velike količine alkohola in/ali imajo anamnezo bolezni jeter.
English: Laropiprant and its acyl glucuronide conjugate are the major circulating components in human plasma.
Slovenian: Laropiprant in njegov acilglukuronidni konjugat sta pri človeku glavni v plazmi krožeči spojini.
English: Effect on glucose
Slovenian: Vpliv na glukozo
English: • Take Pelzont with food.
Slovenian: • Vzemite ga s hrano.
English: The effect on lipids was similar whether Pelzont was given as monotherapy or was added to ongoing statin therapy with or without ezetimibe.
Slovenian: Učinek na lipide je bil podoben, naj je bilo zdravilo Pelzont uporabljeno v monoterapiji ali dodano že vpeljanemu statinskemu zdravljenju, z ezetimibom ali brez njega.
English: Caution should be exercised in patients with pre-disposing factors for rhabdomyolysis.
Slovenian: Previdnost je potrebna pri bolnikh z že obstoječimi dejavniki za pojav rabdomiolize:
English: Effects of laropiprant on other medicinal products
Slovenian: Vplivi laropipranta na druga zdravila
English: Supplements containing nicotinic acid: Vitamins or other nutritional supplements containing (≥ 50 mg/day) of nicotinic acid (or nicotinamide) have not been studied with Pelzont.
Slovenian: Dodatki, ki vsebujejo nikotinsko kislino: Uporaba vitaminov in drugih prehranskih dopolnil, ki vsebujejo (≥ 50 mg/dan) nikotinsko kislino (ali nikotinamid) hkrati z zdravilom Pelzont ni raziskana.
English: If Pelzont is missed for less than 7 consecutive days, patients can resume therapy at the last administered dose.
Slovenian: Če bolnik zdravila Pelzont ne vzame manj kot 7 dni zapored, ga lahko znova začne jemati v nazadnje uporabljanem odmerku.
English: Genetic and pharmacologic studies in animal models have provided evidence that PGD2, acting through DP1, one of the two receptors for PGD2, plays a key role in nicotinic acid-induced flushing.
Slovenian: Z genetskimi in farmakološkimi študijami na živalskih modelih so dokazali, da je za zardevanje zaradi nikotinske kisline ključno delovanje PGD2, ki deluje preko DP1, ki je eden od dveh receptorjev za PGD2.
English: In interaction studies, laropiprant did not have clinically significant effects on the pharmacokinetics of the following medicinal products: simvastatin, warfarin, oral contraceptives, rosiglitazone and digoxin.
Slovenian: V študijah medsebojnega delovanja zdravil laropiprant ni klinično pomembno vplival na farmakokinetiko naslednjih zdravil: simvastatina, varfarina, peroralnih kontraceptivov, roziglitazona in digoksina.
English: Other medicinal products: Co-administration of laropiprant 40 mg with midazolam increased the AUC0-∞ and Cmax of 1'-hydroxymidazolam, a midazolam metabolite, by 98 % and 59 %, respectively.
Slovenian: Druga zdravila: Pri sočasni uporabi 40 mg laropipranta in midazolama sta se povečali AUC0-∞ in Cmax midazolamovega presnovka 1'-hidroksimidazolama za 98 % oz. 59 %.
English: In vitro studies have shown that the acyl glucuronide conjugate of laropiprant had at least a 65-fold reduced affinity for DP1 as compared to laropiprant; thus, it is not expected to contribute to the overall DP1 activity of laropiprant.
Slovenian: Po študijah in vitro ima acilglukuronidni konjugat laropipranta vsaj 65-krat manjšo afiniteto za DP1 kot laropiprant, zato ni pričakovati, da bi prispeval k celotni DP1-aktivnosti laropipranta.
English: Flushing is the most common adverse reaction of Pelzont.
Slovenian: Zardevanje je najpogostejši neželeni učinek zdravila Pelzont.
English: Nicotinic acid is less than 20 % bound to serum proteins.
Slovenian: Manj kot 20 % nikotinske kisline se veže na beljakovine v serumu.
English: Laropiprant is not expected to inhibit the production of prostaglandins.
Slovenian: Ni pričakovati, da bi laropiprant zaviral nastajanje prostaglandinov.
English: • clopidogrel and acetylsalicylic acid (ASA), medicines to help prevent harmful blood clots.
Slovenian: • klopidogrel in acetilsalicilno kislino, ki sta zdravili za preprečevanje škodljivih krvnih strdkov.
English: • you or close family members have a hereditary muscle disorder, or you have ever had muscle problems during treatment with cholesterol-lowering medicines called “statins” or fibrates.
Slovenian: • če imate vi ali vaš ožji družinski član dedno bolezen mišic, ali ste kdaj tekom zdravljenja z zdravili za zniževanje holesterola, imenovanimi statini ali fibrati, imeli težave z mišicami.
English: 1'-hydroxymidazolam is metabolised predominantly by uridine diphosphate-glucuronosyltransferases (UGT) 2B4 and 2B7.
Slovenian: 1'-hidroksimidazolam se presnavlja predvsem z uridindifosfat-glukuronoziltransferazama (UGT) 2B4 in 2B7.
English: • dry skin
Slovenian: • suha koža
English: If you forget to take Pelzont
Slovenian: Če ste pozabili vzeti zdravilo Pelzont
English: If you stop taking Pelzont Do not stop taking Pelzont without talking to your doctor.
Slovenian: Ne nehajte jemati zdravila Pelzont, ne da bi se posvetovali s svojim zdravnikom.
English: HDL is hypothesised to participate in the transport of cholesterol from tissues back to the liver, to suppress vascular inflammation associated with atherosclerosis, and to have anti-oxidative and anti-thrombotic effects.
Slovenian: HDL domnevno sodeluje v prenosu holesterola iz tkiv nazaj v jetra, zavira z aterosklerozo povezano žilno vnetje ter deluje antioksidativno in antitrombotično.
English: Like other nicotinic acid medicinal products, Pelzont is contraindicated in patients with significant or unexplained hepatic dysfunction.
Slovenian: Tako kot druga zdravila z nikotinsko kislino je tudi zdravilo Pelzont kontraindicirano pri bolnikih s pomembno ali nepojasnjeno motnjo delovanja jeter.
English: • to lower your ‘bad' cholesterol level.
Slovenian: • znižanje "slabega" holesterola.
English: Patients with combined mixed dyslipidaemia have high blood levels of ‘bad' LDL cholesterol and triglycerides (a type of fat), and low levels of ‘good' HDL cholesterol.
Slovenian: Bolniki s kombinirano mešano dislipidemijo imajo v krvi visoke vrednosti "slabega" LDL holesterola in trigliceridov (vrsta maščobe) in nizke vrednosti "dobrega" HDL holesterola.
English: • you have unexplained muscle pain, muscle tenderness, or muscle weakness.
Slovenian: • če imate nepojasnjene bolečine v mišicah, občutljive ali šibke mišice.
English: The reduction in flushing symptoms (assessed by patient questionnaires) was correlated with a reduction in nicotinic acid-induced vasodilatation (assessed by measurements of skin blood flow).
Slovenian: Zmanjšanje simptomov zardevanja (ocenjeno z vprašalniki za bolnike) je bilo povezano z zmanjšanjem vazodilatacije zaradi nikotinske kisline (vazodilatacijo so ugotavljali z merjenjem pretoka krvi skozi kožo).
English: Nicotinic acid causes a relative shift in the distribution of LDL subclasses from small, dense (most atherogenic) LDL particles to larger LDL particles.
Slovenian: Farmakodinamični učinki Nikotinska kislina povzroči relativen premik porazdelitve podskupin LDL od majhnih, gostih (najbolj aterogenih) delcev LDL proti večjim delcem LDL.
English: • flushing (which usually includes redness of the skin, feeling warm, itching, or tingling, particularly in the head, neck, chest and upper back).
Slovenian: • zardevanje (ki ponavadi vključuje pordelost kože, občutek toplote, srbenje ali mravljinčenje, še zlasti v predelu glave, vratu, prsi in zgornjega dela hrbta).
English: It is not known if Pelzont will pass into your breast milk.
Slovenian: Ni znano, ali zdravilo Pelzont prehaja v materino mleko.
English: Nicotinic acid-induced flushing is mediated primarily by release of prostaglandin D2 (PGD2) in the skin.
Slovenian: Zardevanje zaradi nikotinske kisline je predvsem posledica sproščanja prostaglandina D2 (PGD2) v koži.
English: • When new information is received that may impact on the current Safety Specification,
Slovenian: • po prejemu novih informacij, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjšanje tveganja,
English: When driving vehicles or operating machines, it should be taken into account that dizziness has been reported (see section 4.8).
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Pri vožnji oz. upravljanju s stroji je treba upoštevati, da so poročali o omotici (glejte poglavje 4.8).
English: • The active substances are nicotinic acid and laropiprant.
Slovenian: • Zdravilni učinkovini sta nikotinska kislina in laropiprant.
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
Slovenian: Pogosti: zvišanje ALT in/ali AST (zaporedno, ≥ 3 x ZMN), glukoze na tešče (glejte spodaj) Občasni: zvišanje CK (≥ 10 x ZMN), LDH, sečne kisline (glejte spodaj)
English: Therefore, treatment with acetylsalicylic acid to alleviate flushing symptoms is not necessary (see section 5.1).
Slovenian: Zato za ublažitev simptomov zardevanja ni treba uporabljati acetilsalicilne kisline (glejte poglavje 5.1).
English: • swelling of the fingers, toes or ankles
Slovenian: • oteklost prstov na rokah in nogah ali gležnjev
English: • medicines used to lower cholesterol called ‘statins'.
Slovenian: • zdravila za zniževanje holesterola, ki jih imenujemo "statini".
English: Additional explanations that do not invoke plasma FFA reduction as the central driver of lipid profile modification include nicotinic acid-mediated inhibition of de novo lipogenesis or esterification of fatty acids into TG in the liver.
Slovenian: Dodatne razlage, ki ne zajemajo znižanja PMK v plazmi kot glavnega gonila sprememb sestave lipidov, vključujejo z nikotinsko kislino posredovano zavrtje de novo lipogeneze ali esterifikacijo maščobnih kislin v trigliceride v jetrih.
English: Very few medicinal products are known to be metabolised predominantly by UGT2B4 or UGT2B7.
Slovenian: Za zelo malo zdravil je znano, da se presnavljajo pretežno z UGT2B4 ali UGT2B7.
English: Laropiprant is not a substrate of human P-gp, and therefore other inhibitors of CYP3A4 and/or P-gp are also not expected to have a clinically meaningful impact on the pharmacokinetics of laropiprant.
Slovenian: Laropiprant ni substrat humanega P-gp, zato ni pričakovati, da bi drugi zaviralci CYP3A4 in/ali P-gp klinično pomembno vplivali na farmakokinetiko laropipranta.
English: Nicotinic acid was not carcinogenic in mice when administered for the duration of their life.
Slovenian: Nikotinska kislina ni bila kancerogena pri miših, ki so jo dobivale vse življenje.
English: At higher doses or higher rates of absorption, the NAD pathway is saturable, and an increasing fraction of the oral dose reaches the bloodstream unchanged as nicotinic acid.
Slovenian: Med uporabo večjih odmerkov oz. pri večji absorpciji pa se NAD-pot nasiti in vse večji delež peroralnega odmerka pride v krvni obtok kot nespremenjena nikotinska kislina.
English: The placebo-adjusted LDL-C, HDL-C and TG responses appeared greater among women compared to men and appeared greater among elderly patients (≥ 65 years) compared to younger patients (< 65 years).
Slovenian: S placebom korigirani odzivi hLDL, hHDL in trigliceridov so bili pri ženskah večji kot pri moških in pri starejših bolnikih (≥ 65 let) večji kot pri mlajših (< 65 let).
English: • you have ever had liver disease, jaundice (a liver disorder causing yellowing of the skin and whites of the eyes), or hepatobiliary (liver and bile duct) disease.
Slovenian: • če ste kdaj imeli bolezen jeter, zlatenico (bolezen jeter, ki povzroči porumenitev kože in očesne beločnice) ali bolezni jeter in žolčnih vodov.
English: LDL cholesterol is often called ‘bad' cholesterol because it can build up in the walls of your arteries and form plaque.
Slovenian: LDL holesterol pogosto imenujemo "slabi" holesterol, ker se lahko kopiči v stenah arterij in tako povzroči nastanek leh.
English: If you get dizzy, you should avoid driving or operating machines after taking Pelzont.
Slovenian: Če postanete omotični, se med jemanjem zdravila Pelzont izogibajte vožnji ali upravljanju strojev.
English: If you take more Pelzont than you should
Slovenian: Če ste vzeli večji odmerek zdravila Pelzont, kot bi smeli
English: After 4 weeks, your doctor may raise your dose of Pelzont to two tablets a day.
Slovenian: Po 4 tednih vam zdravnik lahko odmerek poveča na dve tableti zdravila Pelzont na dan.
English: In order for your medicine to work as intended, do not split, break, crush, or chew the tablet before you swallow it.
Slovenian: Da bo zdravilo delovalo tako kot mora, tablet ne razpolavljajte, ne lomite, ne drobite in ne grizite, preden jih pogoltnete.
English: Common: erythema; pruritus; rash; urticaria Uncommon: dry skin; macular rash Rare: acanthosis nigricans; hyperpigmentation; sweating (night or cold sweat)
Slovenian: Pogosti: eritem; pruritus; izpuščaj; urtikarija Občasni: suha koža; makularni izpuščaj Redki: acanthosis nigricans; hiperpigmentacija; znojenje (nočno znojenje ali hladen znoj)
English: Nicotinic acid lowers the levels of low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), very low density lipoprotein cholesterol (VLDL-C), apolipoprotein B (apo B, the major LDL protein), triglycerides (TG), and lipoprotein(a) (Lp(a), a modified LDL particle) and elevates the levels of high-density lipoprotein cholesterol (HDL-C) and apolipoprotein A-I (apo A-I, the major protein component of HDL).
Slovenian: Nikotinska kislina znižuje koncentracijo LDL holesterola (hLDL), celotnega holesterola (Ch), VLDL holesterola (hVLDL), apolipoproteina B (apo B, glavne beljakovine LDL), trigliceridov (TG) in lipoproteina(a) (Lp(a), spremenjenega delca LDL) ter zvišuje koncentracijo HDL holesterola (hHDL) in apolipoproteina A-I (apo A-I, glavne beljakovinske sestavine HDL).
English: After four weeks, it is recommended that patients be advanced to the maintenance dose of 2,000 mg/40 mg taken as two modified-release tablets (1,000 mg/20 mg each) once daily.
Slovenian: Po štirih tednih je bolnike priporočljivo prevesti na vzdrževalni odmerek 2.000 mg/40 mg v obliki dveh tablet s prirejenim sproščanjem (vsaka 1.000 mg/20 mg) enkrat na dan.
English: The frequencies of adverse reactions are ranked according to the following: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), Not known (cannot be estimated from the available data).
Slovenian: občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana
English: With low doses of nicotinic acid or lower rates of absorption, the first pathway predominates.
Slovenian: Med uporabo majhnih odmerkov nikotinske kisline oz. pri majhni absorpciji prevladuje prva pot.
English: Nicotinic acid undergoes extensive first-pass metabolism through two pathways that are dose and dose-rate dependent.
Slovenian: Nikotinska kislina je podvržena znatni presnovi prvega prehoda po dveh poteh, ki sta odvisni od odmerka in deleža absorpcije.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Pelzont in all subsets of the paediatric population in homozygous familial hypercholesterolaemia (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom Pelzont za vse skupine pediatrične populacije s homozigotno družinsko hiperholesterolemijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Marked and persistent increases of serum transaminases have been reported infrequently (see section 4.4).
Slovenian: Preiskave Redko so poročali o izrazitem in stalnem porastu serumskih transaminaz (glejte poglavje 4.4).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Pelzont in paediatric patients from 7-18 years old in heterozygous familial hypercholesterolaemia (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom Pelzont pri pediatričnih bolnikih s heterozigotno družinsko hiperholesterolemijo, starih od 7-18 let (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Switching from immediate-release (crystalline) nicotinic acid to Pelzont has not been studied.
Slovenian: Prehod z nikotinske kisline s takojšnjim sproščanjem (kristalne nikotinske kisline) na zdravilo Pelzont ni raziskan.
English: Bioavailability with or without food is at least 72 % based on the recovery of the nicotinic acid dose in the urine.
Slovenian: Biološka uporabnost nikotinske kisline, zaužite s hrano ali brez nje, je na podlagi pojavljanja njenega odmerka v urinu vsaj 72 %.
English: • you currently have liver problems.
Slovenian: • če imate trenutno težave z jetri.
English: Laboratory abnormalities included increased amylase and lipase, decreased haematocrit and occult blood in the stool.
Slovenian: Med nenormalnimi laboratorijskimi vrednostmi so bile zvišane amilaze in lipaze, znižan hematokrit in okultna kri v blatu.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH
Slovenian: A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN
English: Pelzont contains a sugar called lactose.
Slovenian: Pelzont vsebuje sladkor, imenovan laktoza.
English: Therefore, patients undergoing surgery should be carefully evaluated.
Slovenian: Zato morate bolnike, ki imajo predvideno operacijo, natančno oceniti.
English: The pharmacokinetic interaction of Pelzont with statins has been studied only with simvastatin (see section 4.4).
Slovenian: Izmed statinov, so farmakokinetične interakcije zdravila Pelzont raziskali samo s simvastatinom (glejte poglavje 4.4).
English: However, the plasma concentration of a metabolite of midazolam, 1'-hydroxymidazolam, was increased approximately 2-fold with multiple doses of laropiprant.
Slovenian: Toda koncentracija midazolamovega presnovka 1'-hidroksimidazolama v plazmi se je med uporabo večkratnih odmerkov laropipranta povečala za približno 2-krat.
English: Nicotinic acid: see sections 4.3 and 4.4.
Slovenian: Nikotinska kislina: glejte poglavji 4.3 in 4.4.
English: • Active peptic ulcer disease.
Slovenian: • Aktivna ulkusna bolezen želodca.
English: Laropiprant has no effect on lipid levels nor does it interfere with the effects of nicotinic acid on lipids.
Slovenian: Laropiprant ne vpliva na koncentracijo lipidov in ne ovira učinkov nikotinske kisline na lipide.
English: Pharmacokinetic steady state is achieved within 2 days of once-daily dosing of laropiprant, with minimal accumulation in AUC (approximately 1.3-fold) and Cmax (approximately 1.1-fold).
Slovenian: farmakokinetično stanje dinamičnega ravnovesja je doseženo v 2 dneh uporabe laropipranta enkrat na dan z minimalnim porastom AUC (približno 1,3-krat) in Cmax (približno 1,1-krat).
English: Diabetic or potentially diabetic patients should be observed closely.
Slovenian: Sladkorne bolnike in potencialne sladkorne bolnike morate natančno spremljati.
English: • Taking aspirin before you take Pelzont does not reduce your flushing more than taking Pelzont alone.
Slovenian: • Jemanje acetilsalicilne kisline pred zaužitjem zdravila Pelzont ne bo bolj zmanjšalo zardevanja, kot če vzamete samo zdravilo Pelzont.
English: The mechanisms by which nicotinic acid modifies the plasma lipid profile are not fully understood.
Slovenian: Mehanizmi delovanja nikotinske kisline na sestavo lipidov v plazmi niso povsem pojasnjeni.
English: In the second study (16 weeks) where acetylsalicylic acid was allowed, patients taking Pelzont 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).
Slovenian: V drugi študiji (16 tednov), v kateri je bilo dovoljeno uporabljati acetilsalicilno kislino, so bolniki, ki so prejemali zdravilo Pelzont, 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).
English: Ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete to zdravilo.
English: • dizziness upon standing
Slovenian: • omotica, ko vstanete