FrancophonIA/ELRC3.0 huggingface dataset:
English: The apparent terminal half-life (t1/2) following a 40 mg dose of laropiprant administered as two modified-release tablets of nicotinic acid/laropiprant with food was approximately 17 hours.
Slovenian: Navidezni terminalni razpolovni čas (t1/2) po 40 mg odmerku laropipranta, uporabljenem v dveh tabletah laropipranta/nikotinske kisline s prilagojenim sproščanjem in s hrano, je bil približno 17 ur.
English: The most commonly reported adverse reactions from the subjects who received this higher dose were consistent with a high dose of nicotinic acid and included: flushing, headache, pruritus, nausea, dizziness, vomiting, diarrhoea, epigastric and abdominal pain/discomfort, and back pain.
Slovenian: Osebe, ki so dobie ta višji odmerek, so najpogosteje poročale o neželenih učinkih, ki so se skladali z neželenimi učinki velikih odmerkov nikotinske kisline in vključujejo: zardevanje, glavobol, srbenje, navzeo, omotico, bruhanje, drisko, bolečine ali nelagodje v epigastriju in trebuhu, bolečine v hrbtu.
English: Patients receiving Pelzont, 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].
Slovenian: (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].
English: In clinical trials, over 5,700 patients received Pelzont alone or with an HMG-CoA reductase inhibitor.
Slovenian: 4.8 Neželeni učinki V kliničnih preskušanjih je zdravilo Pelzont samo ali skupaj z zaviralcem reduktaze HMG-CoA dobivalo več kot 5.700 bolnikov.
English: Like other lipid-lowering therapies, nicotinic acid medicinal products have been associated with abnormal liver function tests (see section 4.8).
Slovenian: Tako kot druga zdravila za zniževanje lipidov so lahko tudi zdravila z nikotinsko kislino povezana z nenormalnimi izvidi testov delovanja jeter (glejte poglavje 4.8).
English: Over time, this plaque build-up can lead to a clogging of your arteries.
Slovenian: Naraščanje leh lahko sčasoma zoži arterije.
English: If you are switching from a medicine with less than 2,000 mg of prolonged-nicotinic acid, you should start by taking one tablet of Pelzont a day.
Slovenian: Če prehajate z zdravila, ki vsebuje manj kot 2.000 mg nikotinske kisline s podaljšanim sproščanjem, morate na začetku jemati po eno tableto zdravila Pelzont na dan.
English: Toxicologic findings in these co-administration studies were consistent with those seen with nicotinic acid and laropiprant administered individually.
Slovenian: Toksikološki izsledki v teh študijah sočasne uporabe so se skladali z izsledki uporabe same nikotinske kisline in samega laropipranta.
English: There are no data from the combined use of nicotinic acid and laropiprant in pregnant women.
Slovenian: O kombinirani uporabi nikotinske kisline in laropipranta pri nosečnicah ni podatkov.
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 Laropiprant se presnovi predvsem z acilglukuronidacijo, z manjšim deležem oksidativne presnove; temu sledi izločanje glukuronida v blatu (z žolčem) in urinu.
English: Nicotinic acid medicinal products have been associated with increases of fasting blood glucose levels (see section 4.8).
Slovenian: Zdravila z nikotinsko kislino so povezana z zvišanjem koncentracije glukoze v krvi na tešče (glejte poglavje 4.8).
English: As no effect was observed in severe renal insufficiency, no effect is expected in patients with mild and moderate renal insufficiency; however, the effects of end-stage renal failure and dialysis on laropiprant pharmacokinetics cannot be inferred from this study.
Slovenian: Ker ni bilo opaznega učinka pri hudi ledvični insuficienci, ga tudi pri blagi in zmerni insuficienci ni pričakovati.
English: Laropiprant crosses the placenta in rats and rabbits.
Slovenian: Laropiprant pri podganah in kuncih prehaja skozi placento.
English: Capsule-shaped, white to off-white tablet, with “552” debossed on one side.
Slovenian: tableta s prirejenim sproščanjem tablete v obliki kapsule in bele do kremaste barve z vtisnjeno oznako "552" na eni strani
English: Uncommon: myalgia Rare: muscular weakness
Slovenian: Redki: mišična šibkost
English: Nicotinic acid
Slovenian: Nikotinska kislina
English: How to take Pelzont
Slovenian: Kako jemati zdravilo Pelzont
English: Mice in this study received approximately 9 to 13 times a human nicotinic acid dose of 2,000 mg/day as determined on a mg/m2 basis.
Slovenian: Miši v tej študiji so (glede na mg/m2) dobivale približno 9- do 12-kratnik človeškega odmerka 2.000 mg nikotinske kisline na dan.
English: Common: abdominal pain; diarrhoea; dyspepsia; nausea; vomiting Rare: mouth oedema; eructation; peptic ulcer
Slovenian: Pogosti: bolečine v trebuhu; diareja; dispepsija; navzea; bruhanje Redki: edem ust; spahovanje; peptična razjeda
English: • Your doctor should do a blood test before you start taking Pelzont to check how well your liver is working.
Slovenian: • Pred začetkom uporabe zdravila Pelzont vas mora zdravnik poslati na preiskavo krvi, da bo preveril delovanje vaših jeter.
English: As with other nicotinic acid medicinal products, patients with a history of jaundice, hepato-biliary disorder or peptic ulcer should be observed closely (see sections 4.2 and 4.3).
Slovenian: Druge informacije Tako kot velja za druga zdravila z nikotinsko kislino, morate bolnike z anamnezo zlatenice, bolezni jeter in žolčnika ali želodčne razjede pozorno spremljati (glejte poglavji 4.2 in 4.3).
English: Laropiprant: No dose adjustment is necessary in the elderly.
Slovenian: Laropiprant: Pri starejših odmerjanja ni treba prilagoditi.
English: approximately 68 % of the dose was recovered in faeces (primarily as parent compound, comprising unabsorbed active substance and/or hydrolysed glucuronic acid conjugate) and 22 % was recovered in urine (primarily as metabolites).
Slovenian: Po peroralni uporabi 14C-laropipranta pri človeku se je 68 % odmerka pojavilo v blatu (predvsem v obliki matične snovi, vključno z neabsorbiranim zdravilom in/ali hidroliziranim konjugatom z glukuronsko kislino), 22 % pa v urinu (predvsem v obliki presnovkov).
English: The mean volume of distribution at steady state following a single 40 mg intravenous dose of laropiprant to healthy subjects is approximately 70 litres.
Slovenian: Pri zdravih preiskovancih je povprečni volumen porazdelitve v stanju dinamičnega ravnovesja po posamičnem 40 mg intravenskem odmerku laropipranta približno 70 litrov.
English: In a multicentre, double-blind, 12-week factorial study, Pelzont 1,000 mg/20 mg co-administered with simvastatin, when compared with simvastatin alone or Pelzont 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 Pelzont 1.000 mg/20 mg skupaj s simvastatinom v primerjavi s simvastatinom samim oz. z zdravilom Pelzont 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.
English: Prolongation of collagen-induced platelet aggregation was observed in subjects taking multiple doses of 300 mg or greater (see section 5.1).
Slovenian: Pri preiskovancih, ki so jemali večkratne odmerke 300 mg ali več, so opazili podaljšanje s kolagenom izzvane agregacije trombocitov (glejte poglavje 5.1).
English: Pelzont (2000 mg/40 mg) co-administered with simvastatin when compared with simvastatin alone or Pelzont (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: Zdravilo Pelzont 2.000 mg/40 mg, uporabljen sočasno s simvastatinom, je v primerjavi s samim simvastatinom ali samim zdravilom Pelzont 2.000 mg/40 mg v 12 tednih bistveno znižalo 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.
English: • See your doctor regularly to check your LDL (bad) and HDL (good) cholesterol levels and your triglyceride level.
Slovenian: • Redno obiskujte zdravnika, da boste preverili raven LDL holesterola (slabi holesterol), HDL
English: Physicians should consider the nicotinic acid intake from vitamins and nutritional supplements when prescribing Pelzont.
Slovenian: Pri predpisovanju zdravila Pelzont morate upoštevati vnos nikotinske kisline z vitamini in prehranskimi dopolnili.
English: There are no adequate data from the use of high dose nicotinic acid in pregnant women.
Slovenian: O uporabi velikih odmerkov nikotinske kisline pri nosečnicah ni dovolj podatkov.
English: Paediatric population Pelzont: No studies have been performed in paediatric patients.
Slovenian: Pelzont: Študij pri pediatričnih bolnikih niso izvedli.
English: Each tablet contains 1000 mg nicotinic acid and 20 mg laropiprant.
Slovenian: Vsaka tableta vsebuje 1.000 mg nikotinske kisline in 20 mg laropipranta.
English: If muscle pain, weakness or cramps occur while a patient is receiving Pelzont with a statin, their CK levels should be measured.
Slovenian: Če se med jemanjem zdravila Pelzont skupaj s statinom pojavijo bolečine v mišicah, oslabelost mišic ali mišični krči, je treba bolniku izmeriti raven CK.
English: TP plays a role in platelet function; however, therapeutic doses of laropiprant had no clinically relevant effect on bleeding time and collagen-induced platelet aggregation (see section 4.5).
Slovenian: TP igra vlogo pri delovanju trombocitov; vendar terapevtski odmerki laropipranta niso klinično pomembno vplivali na čas krvavitve ali agregacijo trombocitov, izzvano s kolagenom (glejte poglavje
English: • Swallow each tablet whole.
Slovenian: • Tablete morate pogoltniti cele.
English: Because the risk of myopathy with statins is dose-related, the use of Pelzont 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 Pelzont 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 Pelzont in s simvastatinom ali z ezetimibom/simvastatinom.
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: • upset stomach or heartburn
Slovenian: • razdražen želodec ali zgaga
English: 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.
Slovenian: HDL holesterol pogosto imenujemo "dobri" holesterol, ker pomaga preprečevati kopičenje "slabega"
English: Therefore, caution should be used when treating Chinese patients with Pelzont 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 Pelzont skupaj s simvastatinom ali z ezetimibom/simvastatinom (zlasti pri odmerkih simvastatina 40 mg ali več) potrebna previdnost.
English: Nicotinic acid For an overdose of nicotinic acid, supportive measures should be employed.
Slovenian: V primeru prevelikega odmerjanja nikotinske kisline je treba uporabiti podporne ukrepe.
English: Physicians contemplating combined therapy with statins and Pelzont 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: In patients continuing in the first study (24 weeks), the frequency of moderate or greater flushing in patients treated with Pelzont 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 Pelzont, zmanjšala in se je približala tisti pri bolnikih, ki so dobivali placebo (glejte sliko 1).
English: Uncommon: hypersensitivity reaction (see below) Rare: angio-oedema; type I hypersensitivity Not known: anaphylactic shock
Slovenian: Občasni: preobčutljivostne reakcije (glejte spodaj) Redki: angioedem; preobčutljivost tipa I
English: Each modified-release tablet contains 128.4 mg of lactose monohydrate.
Slovenian: Pomožne snovi z znanim učinkom: Ena tableta s prirejenim sproščanjem vsebuje 128,4 mg laktoze monohidrata.
English: Pelzont 1,000 mg/20 mg modified-release tablets nicotinic acid/laropiprant
Slovenian: Pelzont 1.000 mg/20 mg tablete s prirejenim sproščanjem nikotinska kislina/laropiprant
English: 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.
Slovenian: (NOAEL) je bila vsaj 118-krat tolikšna, kot je (na podlagi AUC) izpostavljenost med uporabo priporočenega dnevnega odmerka pri človeku.
English: Nicotinic acid was not teratogenic in rats and rabbits up to exposure levels approximately 253 and 104 times the human AUC of nicotinic acid at the recommended daily human dose, respectively.
Slovenian: Nikotinska kislina ni imela teratogenih učinkov pri podganah in kuncih pri izpostavljenostih, ki so bile do približno 253- oz. 104-kratnik vrednosti AUC nikotinske kisline pri človeku pri priporočenem dnevnem odmerku za človeka.
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 Pelzont (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 Pelzont (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: • Previous history of muscular toxicity with a statin or fibrate
Slovenian: • anamneza toksičnih učinkov statinov ali fibratov na mišice,
English: • you have gout.
Slovenian: • če imate protin.
English: Laropiprant suppresses PGD2 mediated flushing associated with administration of nicotinic acid.
Slovenian: Laropiprant zavira zardevanje zaradi PGD2, ki spremlja uporabo nikotinske kisline.
English: Laropiprant: No dose adjustment is necessary based on gender.
Slovenian: Laropiprant: Odmerjanja ni treba prilagoditi glede na spol.
English: Aluminium/Aluminium blisters: 18 months.
Slovenian: Pretisni omoti iz PVC/Aclarja: 2 leti Aluminijsko/aluminijski pretisni omoti: 18 mesecev
English: Studies in animals have shown foetal developmental toxicity at high doses of laropiprant (see section 5.3).
Slovenian: Študije na živalih so pokazale škodljive učinke na razvoj ploda pri velikih odmerkih laropipranta (glejte poglavje 5.3).
English: 56 modified-release tablets
Slovenian: 56 tablet s prirejenim sproščanjem
English: Therefore, patients switching from immediate-release nicotinic acid to Pelzont should be initiated at the 1,000 mg/20 mg dose.
Slovenian: Pri bolnikih, ki preidejo na zdravilo Pelzont z nikotinske kisline s takojšnjim sproščanjem, morate zdravljenje začeti z odmerkom 1.000 mg/20 mg.
English: The following adverse reactions have been reported during clinical studies and/or post-marketing use with Pelzont (with or without a statin).
Slovenian: V času kliničnih študij in/ali obdobju trženja zdravila Pelzont (z ali brez statina) so poročali o naslednjih neželenih učinkih.
English: Your total cholesterol is made up mainly of ‘bad' (LDL) and ‘good' (HDL) cholesterol.
Slovenian: Celotni holesterol v glavnem sestavljata "slabi" holesterol (LDL) in
English: Ketonuria and hepatocellular centrilobular hypertrophy were observed in rats in repeated dose toxicity studies for up to 6 months dosing.
Slovenian: Pri podganah so v študijah toksičnosti ponavljajočih se odmerkov med uporabo do 6 mesecev opažali ketonurijo in centrilobularno hipertrofijo jetrnih celic.
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 5.3).
English: No studies in lactating animals have been conducted with Pelzont.
Slovenian: Na doječih živalih študije z zdravilom Pelzont niso bile izvedene.
English: The glycine conjugation pathway is not saturated across the clinically relevant dose range, based on the dose-proportional increase in the plasma concentrations of NUA from 1,000 mg to 2,000 mg.
Slovenian: Pot konjugacije z glicinom pa se v celotnem razponu klinično pomembnih odmerkov ne nasiti, če presojamo na podlagi odmerku sorazmernega porasta koncentracije nikotinurične kisline v plazmi od odmerka
English: Some people get dizzy after taking Pelzont.
Slovenian: Nekateri ljudje po zaužitju zdravila Pelzont postanejo omotični.
English: Triglycerides are another fat in your blood.
Slovenian: Druga vrsta maščob v krvi so trigliceridi.
English: Use of Pelzont in patients with hepatic or renal insufficiency has not been studied.
Slovenian: Bolniki z jetrno ali ledvično insuficienco Uporaba zdravila Pelzont pri bolnikih z jetrno ali ledvično insuficienco ni raziskana.
English: • Avoid drinking alcohol or hot drinks or eating spicy foods near the time you take your dose of Pelzont.
Slovenian: • Ne pijte alkohola ali vročih pijač in ne jejte začinjene hrane malo pred zaužitjem odmerka zdravila
English: 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 a perforated unit dose blister.
Slovenian: Velikosti pakiranj: 14, 28, 56, 84, 98, 168, 196 tablet s prirejenim sproščanjem, multi pakiranje po 196 (2 pakiranji po 98) tablet s prirejenim sproščanjem ter 49 x 1 tableta s prirejenim sproščanjem v perforiranem pretisnem omotu za enkratni odmerek.
English: Clopidogrel: In a clinical study, there was no meaningful effect of laropiprant on the inhibition of ADP-induced platelet aggregation by clopidogrel, but there was a modest increase in the inhibition of collagen-induced platelet aggregation by clopidogrel.
Slovenian: Klopidogrel: V klinični študiji laropiprant ni pomembno vplival na zaviranje z ADP izzvane agregacije trombocitov s klopidogrelom.
English: 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)
Slovenian: Multi pakiranje po 196 (2 zavoja po 98 tablet s prirejenim sproščanjem) - brez blue box-a (s
English: Effect on uric acid
Slovenian: Vpliv na sečno kislino
English: • eye disorders called toxic amblyopia and cystoid macular oedema which may lead to blurred,
Slovenian: • očesnih boleznih, in sicer toksični ambliopiji in cistoidnem makularnem edemu, ki lahko povzročita zameglitev, zmanjšanost ali izgubo vida,
English: Caution should be used when treating Chinese patients with Pelzont co-administered with simvastatin or ezetimibe/simvastatin (particularly simvastatin doses of 40 mg or higher).
Slovenian: Pri zdravljenju kitajskih bolnikov, ki jemljejo zdravilo Pelzont skupaj s simvastatinom ali z ezetimibom/simvastatinom (zlasti pri odmerkih simvastatina 40 mg ali več), je potrebna previdnost.
English: Nicotinic acid also elevates the HDL2 subfraction to a greater extent than the HDL3 subfraction, thereby increasing the HDL2:HDL3 ratio, which is associated with decreased cardiovascular disease risk.
Slovenian: Tako poveča razmerje HDL2:HDL3, kar je povezno z manjšim tveganjem za srčno-žilne bolezni.
English: Periodic serum creatine kinase (CK) should be considered in such situations, but there is no assurance that such monitoring will prevent the occurrence of severe myopathy.
Slovenian: Ni pa zagotovila, da bo takšno spremljanje preprečilo pojav hude miopatije.
English: In these studies, the percentage of patients taking Pelzont, 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: je zdravilo Pelzont 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, Pelzont (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 Pelzont (2.000 mg/40 mg) povezano z majhnim zvišanjem koncentracije sečne kisline (glejte poglavje 4.8).
English: However, nicotinic acid a component of Pelzont does pass into breast milk.
Slovenian: Znano pa je, da v materino mleko prehaja nikotinska kislina, sestavina zdravila Pelzont.
English: To reduce the possibility of flushing, drinking alcohol or hot drinks or eating spicy foods should be avoided at the time of ingestion of the medicinal product.
Slovenian: Da bo možnost zardevanja manjša, naj bolniki v času zaužitja zdravila ne pijejo alkoholnih pijač ali vročih napitkov in ne jedo začinjene hrane.
English: Nicotinic acid: No dose adjustment is necessary based on gender.
Slovenian: Spol Nikotinska kislina: Odmerka ni treba prilagoditi glede na spol.
English: Laropiprant: No dose adjustment is necessary based on race.
Slovenian: Laropiprant: Odmerjanja ni treba prilagoditi glede na raso.
English: Increases in serum alanine aminotransferase (ALT) levels were observed in all dog studies, at systemic exposure levels at least 14 times the human exposure based on the AUC of the recommended daily human dose.
Slovenian: Zvišanje serumske alanin-aminotransferaze (ALT) so opažali v vseh študijah na psih pri izpostavljenosti,
English: flushing, headache, pruritus (itching), nausea, dizziness, vomiting, diarrhoea, abdominal pain/discomfort, and back pain.
Slovenian: zardevanje, glavobol, srbenje, siljenje na bruhanje, omotica, bruhanje, driska, bolečine/nelagodje v trebuhu, bolečine v hrbtu.
English: Acetylsalicylic acid provides no additional reduction of flushing beyond that achieved by Pelzont.
Slovenian: Sočasna zdravila Acetilsalicilna kislina zardevanja ne zmanjša nič bolj, kot ga že zdravilo Pelzont.