FrancophonIA/ELRC3.0 huggingface dataset:
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
English: As with other nicotinic acid medicinal products, Pelzont (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 Pelzont (2.000 mg/40 mg) povezano z majhnim zmanjšanjem števila trombocitov (glejte poglavje 4.8).
English: How to take
Slovenian: Kako morate jemati zdravilo
English: Following a 2,000 mg dose of nicotinic acid administered orally as two modified-release tablets of nicotinic acid/laropiprant with food, nicotinic acid was absorbed with a median time to peak plasma concentration (Tmax) of 4 hours, a mean area under the plasma concentration-time curve (AUC0-last) of approximately 58.0 μM·hr and a mean peak plasma concentration (Cmax) of approximately 20.2 μM.
Slovenian: Po peroralni uporabi 2.000 mg nikotinske kisline v obliki dveh tablet nikotinske kisline/laropipranta s prirejenim sproščanjem, zaužitih s hrano, je bila mediana časa do največje koncentracije nikotinske kisline v plazmi (tmax) 4 ure, povprečna površina pod krivuljo plazemske koncentracije v odvisnoti od časa
English: Respiratory, thoracic, and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Bolezni prebavil
English: Nicotinic acid Nicotinic acid is excreted in human breast milk.
Slovenian: Nikotinska kislina se izloča v materino mleko.
English: Pelzont contains lactose
Slovenian: Zdravilo Pelzont vsebuje laktozo
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)
English: Patients receiving Pelzont 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: Nicotinic acid inhibits release of free fatty acids (FFA) from adipose tissue, which may contribute to the reduced plasma LDL-C, TC, VLDL-C, apo B, TG, and Lp(a), as well as elevated HDL-C, and apo A-I, all of which are associated with lower cardiovascular risk.
Slovenian: To lahko pripomore k znižanju hLDL, Ch, hVLDL, apo B, TG, in Lp(a) v plazmi ter k zvišanju HDL in apo A-I; vse to zmanjšuje srčno-žilno tveganje.
English: As with other nicotinic acid medicinal products, Pelzont was associated with small decreases in phosphorus levels.
Slovenian: Tako kot druga zdravila z nikotinsko kislino je bilo tudi zdravilo Pelzont povezano z manjšim zmanjšanjem koncentracije fosforja, zato morate bolnike s tveganjem za hipofosfatemijo skrbno spremljati.
English: Pelzont is indicated for the treatment of dyslipidaemia, particularly in adult patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL-cholesterol and triglycerides and low HDL-cholesterol) and in adult patients with primary hypercholesterolaemia (heterozygous familial and non-familial).
Slovenian: 4.1 Terapevtske indikacije Zdravilo Pelzont je indicirano za zdravljenje dislipidemije, zlasti pri odraslih bolnikih s kombinirano mešano dislipidemijo (za katero so značilni zvišani LDL holesterol in trigliceridi in nizek HDL
English: • swelling of the lips
Slovenian: • otekanje ustnic
English: • muscle weakness
Slovenian: • šibkost mišic
English: Effects of other medicinal products on laropiprant
Slovenian: Učinki drugih zdravil na nikotinsko kislino
English: Nicotinic acid: No dose adjustment is necessary based on race.
Slovenian: Rasa Nikotinska kislina: Odmerka ni treba prilagoditi glede na raso.
English: Diet and other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with Pelzont.
Slovenian: Med zdravljenjem z zdravilom Pelzont mora bolnik še naprej upoštevati dieto in druge nefarmakološke ukrepe zdravljenja (npr. telesno dejavnost, zmanjšanje telesne mase).
English: If Pelzont 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 Pelzont ne vzame 7 ali več dni zapored, ga mora znova začeti jemati v odmerku 1.000 mg/20 mg 1 teden.
English: EU/1/08/460/009 14 modified-release tablets EU/1/08/460/010 28 modified-release tablets EU/1/08/460/011 56 modified-release tablets EU/1/08/460/013 168 modified-release tablets EU/1/08/460/014 32 x 1 modified-release tablets
Slovenian: EU/1/08/460/009 14 tablet s prirejenim sproščanjem EU/1/08/460/010 28 tablet s prirejenim sproščanjem EU/1/08/460/011 56 tablet s prirejenim sproščanjem
English: No adverse effects on fertility were observed in male or female rats given laropiprant prior to mating and throughout mating, at systemic exposure levels at least 289 times the human exposure based on the AUC of the recommended daily human dose.
Slovenian: Pri podganjih samcih in samicah niso opazili neželenih učinkov na plodnost, ko so živali dobivale laropiprant pred parjenjem in med parjenjem v sistemski izpostavljenosti, vsaj 289-krat tolikšni, kot je (na podlagi AUC) izpostavljenost med uporabo priporočenega dnevnega odmerka pri človeku.
English: In particular, tell your doctor or pharmacist if you are taking any of the following:
Slovenian: Še zlasti morate svojemu zdravniku ali farmacevtu povedati, če jemljete katero od naslednjih zdravil: • zdravila za zniževanje krvnega tlaka.
English: Those patients switching from 2,000 mg or more of prolonged-release nicotinic acid can initiate Pelzont at the 2,000 mg/40 mg dose.
Slovenian: Če bolnik preide na zdravilo Pelzont s pripravka nikotinske kisline s podaljšanim sproščanjem, ki ga je jemal v odmerku 2.000 mg ali več, lahko zdravilo Pelzont začne jemati v odmerku 2.000 mg/40 mg.
English: Similar treatment-related changes were observed in rabbit foetuses but in the presence of maternal toxicity at exposure levels approximately 629 times the human AUC of nicotinic acid at the recommended daily human dose.
Slovenian: Podobne, z zdravilom povezane spremembe, so pri izpostavljenostih, ki so bile približno 629-kratnik vrednosti AUC nikotinske kisline pri človeku pri priporočenem dnevnem odmerku, opazili pri plodih kuncev, vendar so bili pri kuncih prisotni tudi škodljivi maternalni učinki.
English: Women have a modest increase in plasma concentrations of nicotinuric acid and nicotinic acid compared to men.
Slovenian: Koncentracija nikotinurične in nikotinske kisline v plazmi je pri ženskah zmerno večja kot pri moških.
English: No other effects were observed in dog studies with exposures at least 100 times the human exposure based on the AUC of the recommended daily human dose.
Slovenian: V študijah na psih pri vsaj 100-krat tolikšni izpostavljenosti, kot je (na podlagi AUC) med uporabo priporočenega dnevnega odmerka pri človeku, niso opazili nobenih drugih učinkov.
English: Uncommon: chills; pain; peripheral oedema Rare: asthaenia; face oedema; generalised oedema
Slovenian: Redki: astenija; edem obraza; generaliziran edem
English: Gender had no clinically meaningful effect on the pharmacokinetics of laropiprant.
Slovenian: Spol na farmakokinetiko laropipranta ne vpliva klinično pomembno.
English: There is no change in the oral bioavailability of nicotinic acid with age.
Slovenian: Biološka uporabnost peroralno uporabljene nikotinske kisline se s starostjo ne spremeni.
English: EU/1/08/460/001 14 modified-release tablets EU/1/08/460/002 28 modified-release tablets EU/1/08/460/003 56 modified-release tablets EU/1/08/460/004 84 modified-release tablets EU/1/08/460/005 98 modified-release tablets EU/1/08/460/006 168 modified-release tablets EU/1/08/460/007 196 modified-release tablets EU/1/08/460/008 49 x 1 modified-release tablets EU/1/08/460/012 196 (2 packs of 98) modified-release tablets
Slovenian: EU/1/08/460/004 84 tablet s prirejenim sproščanjem EU/1/08/460/005 98 tablet s prirejenim sproščanjem EU/1/08/460/006 168 tablet s prirejenim sproščanjem EU/1/08/460/007 196 tablet s prirejenim sproščanjem
English: • rapid heart rate.
Slovenian: • otekanje nog • hitro bitje srca
English: Pack sizes of 14, 28, 56, 168 modified-release tablets and 32 x 1 modified-release tablets in a perforated unit dose blister.
Slovenian: 28, 56, 168 tabletami s prirejenim sproščanjem ter z 32 x 1 tableto s prirejenim sproščanjem v perforiranem pretisnem omotu za enkratni odmerek.
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 Pelzont with or without a statin.
Slovenian: kontroliranih kliničnih študijah je bila pri bolnikih, ki so prejemali zdravilo Pelzont (s statinom ali brez njega), incidenca klinično pomembnih zvišanj serumskih transaminaz (ALT in/ali AST ≥ 3 x ZMN,
English: • getting sick (vomiting)
Slovenian: • slabost (bruhanje)
English: What you need to know before you take Pelzont
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Pelzont Ne jemljite zdravila Pelzont:
English: 4.9 Overdose
Slovenian: 4.9 Preveliko odmerjanje Pelzont
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
English: • rash
Slovenian: • srbež
English: Pelzont contains lactose.
Slovenian: Zdravilo Pelzont vsebuje laktozo.
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
English: • laropiprant, which reduces symptoms of flushing, a common side effect of nicotinic acid.
Slovenian: • nikotinsko kislino, ki je zdravilo z vplivom na maščobe (lipide) in • laropiprant, ki zmanjša simptome zardevanja, pogostega neželenega učinka nikotinske kisline.
English: • you have kidney problems.
Slovenian: • če imate težave z ledvicami.
English: Nervous system disorders
Slovenian: Psihiatrične motnje Bolezni živčevja
English: Retinopathy and/or corneal lesions were observed in dogs following 6 months of dosing at systemic exposure values at least 240 times the human exposure based on the AUC of the recommended daily human dose.
Slovenian: Pri psih so po 6-mesečni uporabi pri sistemski izpostavljenosti, ki je bila na podlagi AUC vsaj 240-krat večja od izpostavljenosti med uporabo priporočenega dnevnega odmerka pri človeku, opažali retinopatijo in/ali spremembe na roženici.
English: Aluminium/Aluminium blister with push-through lidding containing 7 modified-release tablets.
Slovenian: Aluminijsko/aluminijski pretisni omot s prekritjem, skozi katerega se potisne tableta; omot vsebuje
English: It should be used with caution in patients with renal insufficiency, because nicotinic acid and its metabolites are primarily excreted by the kidneys (see sections 4.3, 4.4 and 5.2).
Slovenian: kajti nikotinska kislina in njeni presnovki se izločajo predvsem skozi ledvice (glejte poglavja 4.3, 4.4 in
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 71 %.
English: Hepatic insufficiency Pelzont: Use in patients with hepatic insufficiency has not been studied.
Slovenian: Pelzont: Uporaba pri bolnikih z jetrno insuficienco ni raziskana.
English: • patches of darkened skin
Slovenian: • temne lise na koži
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Pelzont.
Slovenian: Če niste prepričani, ali kaj od naštetega velja za vas, se, preden vzamete zdravilo Pelzont, posvetujte z zdravnikom ali s farmacevtom.
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 Pelzont.
Slovenian: V času zaužitja zdravila Pelzont se je treba izogibati pitju alkohola, vročih pijač ali uživanju začinjene hrane, ker to lahko poveča zardevanje.
English: However, cases of severe hepatic toxicity, including fulminant hepatic necrosis, have occurred in patients who have switched from immediate-release nicotinic acid to long-acting nicotinic acid at equivalent doses.
Slovenian: Vendar pa so se pri bolnikih, ki so z nikotinske kisline s takojšnjim sproščanjem prešli na njeno dolgodelujočo obliko v enakovrednem odmerku, pojavili primeri hudih toksičnih učinkov na jetra
English: Nicotinic acid: There is no pharmacokinetic data in the elderly (≥ 65 years).
Slovenian: Nikotinska kislina: Farmakokinetičnih podatkov za starejše (≥ 65 let) ni. Glede na sestavljeno analizo preiskovancev, starih od 18 do 65 let, starost na farmakokinetiko nikotinske kisline (pripravka s podaljšanim sproščanjem) ne vpliva klinično pomembno.
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 Pelzont.
Slovenian: • Da zmanjšate možnost zardevanja, v času zaužitja zdravila Pelzont (ter malo pred tem in po tem) ne pijte alkohola ali vročih pijač in ne jejte začinjene hrane.
English: Primary means that the hypercholesterolaemia does not have any identifiable cause.
Slovenian: Za primarno hiperholesterolemijo je značilna visoka vrednost holesterola v krvi, primarna pa se imenuje zato, ker niso ugotovili nobenega vzroka za nastanek.
English: Renal dysfunction
Slovenian: Motnje v delovanju ledvic
English: LDL cholesterol, fatty substances called triglycerides and apo B (a part of LDL) in the blood;
Slovenian: Ta učinek zdravilo doseže tako, da v krvi zniža raven celotnega holesterola, LDL holesterola, maščobnih snovi, imenovanih trigliceridi, in apo B (ki je del LDL).
English: This will lower your chance of flushing (redness of the skin, feeling warm, itching, or tingling, particularly in your head, neck, chest and upper back).
Slovenian: občutek toplote, srbenje ali mravljinčenje, še zlasti v predelu glave, vratu, prsi in zgornjega dela hrbta).
English: In humans, nicotinamide is further predominantly metabolised to N-methylnicotinamide (MNA) and to N-methyl-2-pyridone-5-carboxamide (2PY).
Slovenian: Pri človeku se nikotinamid nato presnovi v glavnem v N-metilnikotinamid (MNA) in
English: HMG-CoA reductase inhibitors: When simvastatin is combined with nicotinic acid, a modest increase in AUC and Cmax of simvastatin acid (the active form of simvastatin) was observed, which may be devoid of clinical relevance.
Slovenian: in Cmax simvastatinske kisline (aktivne oblike simvastatina) zmerno zvišali, kar je lahko klinično nepomembno.
English: What Pelzont is and what it is used for
Slovenian: Kaj je zdravilo Pelzont in za kaj ga uporabljamo Vaše zdravilo se imenuje Pelzont.
English: • stomach ulcer
Slovenian: • želodčna razjeda
English: Age had no clinically meaningful effect on the pharmacokinetics of laropiprant.
Slovenian: Starost na farmakokinetiko laropipranta ne vpliva klinično pomembno.
English: Nicotinic acid showed no mutagenic effects in the in vitro assays.
Slovenian: V preizkusih in vitro nikotinska kislina ni učinkovala mutageno.
English: • sleeplessness
Slovenian: • omedlevica
English: Rare cases of myopathy/rhabdomyolysis have been associated with concomitant administration of lipid-altering doses (≥ 1,000 mg/day) of nicotinic acid and HMG-CoA reductase inhibitors (statins) (see section 4.8).
Slovenian: ki vplivajo na lipide (≥ 1.000 mg/dan), in zaviralcev reduktaze HMG-CoA (statinov).
English: 14 modified-release tablets 28 modified-release tablets 56 modified-release tablets 168 modified-release tablets 32 x 1 modified-release tablets
Slovenian: 14 tablet s prirejenim sproščanjem 28 tablet s prirejenim sproščanjem 56 tablet s prirejenim sproščanjem 84 tablet s prirejenim sproščanjem 98 tablet s prirejenim sproščanjem 168 tablet s prirejenim sproščanjem 196 tablet s prirejenim sproščanjem
English: Uncommon (may affect up to 1 in 100 people) • gout
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) • glavobol
English: Laropiprant: Consistent with the characteristics of a medicinal product that is primarily cleared by metabolism, moderate hepatic disease has a significant impact on laropiprant pharmacokinetics, with an increase in AUC and Cmax of approximately 2.8- and 2.2-fold respectively.
Slovenian: Laropiprant: Zmerna bolezen jeter močno vpliva na farmakokinetiko laropipranta, kar je pri zdravilu, ki se očisti predvsem s presnovo, pričakovano.
English: Talk with your doctor before taking Pelzont if:
Slovenian: Preden vzamete zdravilo Pelzont, se posvetujte z zdravnikom:
English: This is characterised by multiple symptoms that may include: angio-oedema, pruritus, erythema, paraesthesia, loss of consciousness, vomiting, urticaria, flushing, dyspnoea, nausea, incontinence of urine and stool, cold sweats, shivering, chills, increased blood pressure, lip swelling, burning sensation, drug eruption, arthralgia, leg swelling, and tachycardia.
Slovenian: dispnejo, navzeo, inkontinenco urina in blata, hladno znojenje, drgetanje, mrzlico, zvišan krvni tlak,
English: Pelzont contains nicotinic acid, which at therapeutic doses is a lipid-modifying agent, and laropiprant, a potent, selective antagonist of the prostaglandin D2 (PGD2) receptor subtype 1 (DP1).
Slovenian: močan, selektiven antagonist receptorja prostaglandina D2 (PGD2) podvrste 1 (DP1).
English: • dizziness
Slovenian: • drgetanje
English: Race had no clinically meaningful effect on the pharmacokinetics of laropiprant based on a composite analysis of pharmacokinetic data including subjects of White, Hispanic, Black, Asian, and Native American racial groups.
Slovenian: Glede na sestavljeno analizo farmakokinetičnih podatkov, ki je zajela preiskovance belske, hispanske, črnske, azijske in praameriške rasne skupine, rasa na farmakokinetiko laropipranta ne vpliva klinično pomembno.
English: How to store Pelzont
Slovenian: Shranjevanje zdravila Pelzont
English: • generalised swelling
Slovenian: • generalizirano otekanje
English: Race has no clinically meaningful effect on the pharmacokinetics of nicotinic acid (prolonged-release formulation) based on pharmacokinetic data including subjects of Hispanic, White, Black, and Native American racial groups.
Slovenian: Glede na farmakokinetične podatke preiskovancev, med katerimi so bili pripadniki hispanske, belske, črnske in praameriške rasne skupine, rasa na farmakokinetiko nikotinske kisline (pripravka s podaljšanim sproščanjem) ne vpliva klinično pomembno.
English: 98 modified-release tablets
Slovenian: 98 tablet s prirejenim sproščanjem.
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.
English: BATCH NUMBER Lot
Slovenian: Ukinitev laropipranta
English: Because co-administration of bile acid sequestrants may reduce the bioavailability of acidic medicinal products such as nicotinic acid, it is recommended that Pelzont be administered > 1 hour before or > 4 hours after administration of a bile acid sequestrant (see section 4.5).
Slovenian: Zato je zdravilo Pelzont priporočljivo zaužiti več kot 1 uro pred izmenjevalci žolčnih kislin ali več kot 4 ure po njih (glejte poglavje 4.5).
English: • tingling or numbness of the hands or feet
Slovenian: • mravljinčenje in omrtvelost dlani ali stopal • bolečine v trebuhu
English: Common (may affect up to 1 in 10 people)
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov)
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: Pelzont začeti z odmerkom 1.000 mg/20 mg in po 4 tednih preiti na vzdrževalni odmerek 2.000 mg/40 mg.
English: Pharmacotherapeutic group: Lipid modifying agents, nicotinic acid and derivatives, ATC code: C10AD52.
Slovenian: Oznaka ATC: C10AD52.
English: • fainting
Slovenian: • spahovanje
English: Therefore, Pelzont should be used with caution in patients with or predisposed to gout.
Slovenian: Zato morate pri bolnikih, nagnjenih k protinu, zdravilo Pelzont previdno uporabljati.
English: • nausea (feeling sick)
Slovenian: • siljenje na bruhanje (slabost v želodcu)
English: If you are not sure, talk to your doctor or pharmacist before taking Pelzont.
Slovenian: Če ste negotovi, se posvetujte s svojim zdravnikom ali s farmacevtom.
English: Modified-release tablet.
Slovenian: 7 tablet s prirejenim sproščanjem.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified-release tablet contains 1,000 mg of nicotinic acid and 20 mg of laropiprant.
Slovenian: Ena tableta s prirejenim sproščanjem vsebuje 1.000 mg nikotinske kisline in 20 mg laropipranta.
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: 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: • You are breast-feeding or plan to breast-feed.
Slovenian: • če dojite ali nameravate dojiti.
English: • shivering
Slovenian: • tesnoba
English: Cases of overdose have been reported; the maximum dose of Pelzont taken was 5,000 mg/100 mg. All patients recovered without sequelae.
Slovenian: Poročali so o primerih prevelikega odmerjanja; največji zaužiti odmerek zdravila Pelzont je bil
English: 84 modified-release tablets
Slovenian: 49 x 1 tableta s prirejenim sproščanjem
English: Check with your doctor or pharmacist before and while taking your medicine if:
Slovenian: Preden vzamete in če že jemljete zdravilo, se posvetujte z zdravnikom ali s farmacevtom:
English: • you have thyroid problems.
Slovenian: • če imate težave s ščitnico.
English: Not known: jaundice
Slovenian: Občasni: mialgija
English: In rats, foetotoxic effects (significantly decreased foetal body weights associated with a decrease in the number of ossified sacrocaudal vertebrae and an increased incidence of foetuses with sites of incomplete ossification) were noted in the absence of any signs of maternal toxicity at exposure levels approximately 959 times the human AUC of nicotinic acid at the recommended daily human dose.
Slovenian: Pri podganah so pri izpostavljenostih, ki so bile približno 959-kratnik vrednosti AUC nikotinske kisline pri človeku pri priporočenem dnevnem odmerku, opazili škodljive učinke na plod
English: Common: headache; paraesthesia Uncommon: dizziness Rare: migraine; syncope
Slovenian: Pogosti: občutek vročine Občasni: mrzlica; bolečina; periferni edem
English: • pain
Slovenian: • putika
English: Posology
Slovenian: Zardevanje