natgillin/translations-raw huggingface dataset:
This effect is unlikely to be clinically important as laropiprant did not increase bleeding time when co-administered with clopidogrel throughout the dosing interval.
Malo verjetno je, da bi bil ta učinek klinično pomemben, saj laropiprant v kombinaciji s klopidogrelom tekom uporabe ni podaljšal časa krvavitve.
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study to assess the effects of withdrawal of laropiprant showed that dyslipidaemic patients in whom laropiprant was withdrawn after 20 weeks on Pelzont experienced significantly more flushing than patients who continued taking
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
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).
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
• Uncontrolled hypothyroidism
• neurejen hipotiroidizem,
Therefore, taking aspirin to reduce flushing symptoms is not necessary.
Zato jemanje acetilsalicilne kisline za zmanjšanje zardevanja ni potrebno.
In three large clinical trials measuring patient-reported flushing symptoms, patients taking Pelzont experienced less flushing than those taking nicotinic acid (prolonged-release formulations).
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).
Hypromellose (E464) Colloidal anhydrous silica (E551) Sodium stearyl fumarate Hydroxypropylcellulose (E463) Microcrystalline cellulose (E460) Croscarmellose sodium Lactose monohydrate Magnesium stearate
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
Caution should be used when Pelzont is co-administered with medicinal products metabolised predominantly by UGT2B4 or UGT2B7, for instance zidovudine.
Previdnost je potrebna, če zdravilo Pelzont uporabljate hkrati z zdravili, ki se presnavljajo predvsem z UGT2B4 ali UGT2B7, kot je zidovudin.
Because nicotinic acid and its metabolites are excreted through the kidneys, Pelzont should be used with caution in patients with renal dysfunction.
Nikotinska kislina in njeni presnovki se izločajo skozi ledvice, zato morate pri bolnikih z motenim delovanjem ledvic zdravilo Pelzont uporabljati previdno.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM Sistem farmakovigilance
• you have arterial bleeding.
• če krvavite iz arterije.
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).
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).
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.
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.
The incidence and frequency of moderate or greater flushing in patients treated with Pelzont for the duration of the study decreased.
sta se pojavnost in pogostnost zmernega ali izrazitejšega zardevanja v času študije zmanjšali.
There is no difference in the oral bioavailability of nicotinic acid in men and women receiving Pelzont.
Biološka uporabnost peroralne nikotinske kisline se med moškimi in ženskami, ki so dobivali zdravilo Pelzont, ni razlikovala.
In in vitro studies, laropiprant did not inhibit CYP1A2, CYP2B6, CYP2C19, CYP2D6, or CYP2E1-mediated reactions.
V študijah in vitro laropiprant ni zaviral reakcij, ki potekajo s CYP1A2, CYP2B6, CYP2C19, CYP2D6 ali CYP2E1.
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).
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).
• medicines used to lower cholesterol called ‘bile acid sequestrants', such as colestyramine.
• zdravila za zniževanje holesterola, ki jih imenujemo "adsorbenti žolčnih kislin", npr. holestiramin.
The oxidative metabolism of laropiprant is catalysed primarily by CYP3A4, whereas several UGT isoforms (1A1, 1A3, 1A9 and 2B7) catalysed the acyl glucuronidation.
Oksidativno presnovo laropipranta katalizira predvsem CYP3A4, acilglukuronidacijo pa več izooblik UGT (1A1, 1A3, 1A9 in 2B7).
Contents of the pack and other information
Shranjevanje zdravila Pelzont Vsebina pakiranja in dodatne informacije
Nicotinic acid is predominantly excreted in the urine as metabolites.
Nikotinska kislina se v glavnem izloči v urinu v obliki presnovkov.
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.
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.
• 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.
• 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.
Not known: vesicular or vesiculobullous rash
Neznana: vezikularni ali vezikulobulozni izpuščaj
Patients who develop increased transaminase levels should be monitored until the abnormalities have resolved.
Če se transaminaze zvišajo, morate bolnika spremljati, dokler nepravilnosti ne izginejo.
Laropiprant has been shown to be effective in reducing flushing symptoms induced by nicotinic acid.
Farmakodinamični učinki Pokazalo se je, da laropiprant učinkovito zmanjša simptome zardevanja, ki jih povzroča nikotinska kislina.
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.
Ker je 1'-hidroksimidazolam aktiven presnovek, se lahko sedativni učinek midazolama poveča.
The first pathway results in the formation of nicotinamide adenine dinucleotide (NAD) and nicotinamide.
Po prvi poti nastaneta nikotinamidadenindinukleotid (NAD) in nikotinamid.
CYP3A4 Inhibitor: Clarithromycin (a potent inhibitor of CYP3A4 and P-gp) did not have a clinically meaningful effect on the pharmacokinetics of laropiprant.
Učinki drugih zdravil na laropiprant Zaviralec CYP3A4: Klaritromicin (močan zaviralec CYP3A4 in P-gp) ni klinično pomembno vplival na farmakokinetiko laropipranta.
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).
Glede na te podatke ni pričakovati medsebojnega delovanja laropipranta s substrati izoencimov 3A4, 2C9 in 2C8
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (for PVC/Aclar blister)
PODATKI NA ZUNANJI OVOJNINI Škatla (s PVC/Aclar pretisnimi omoti)
In the second pathway, glycine is conjugated with nicotinic acid to form nicotinuric acid (NUA).
Po drugi poti se glicin konjugira z nikotinsko kislino in nastane nikotinurična kislina.
Haematologic effects
Hematološki učinki
• 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.
• 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.
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.
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.
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 ).
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 %).
Uncommon: gout Rare: impaired glucose tolerance
Presnovne in prehranske motnje Občasni: protin Redki: motena toleranca za glukozo
The combination has not been tested in reproductive toxicity studies.
Vpliv kombinacije na sposobnost razmnoževanja v študijah ni bil raziskan.
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:
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:
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.
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.
The hepatocellular centrilobular hypertrophy was consistent with rodent specific enzyme induction.
Centrilobularna hipertrofija jetrnih celic se je skladala z indukcijo encimov, specifično za glodalce.
There are no data from the use of laropiprant in pregnant women.
O uporabi laropipranta pri nosečnicah ni podatkov.
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).
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).
The pharmacokinetics of laropiprant are linear, displaying approximately dose-proportional increases in AUC and Cmax and no evidence of time-dependent clearance.
Povečevanje AUC in Cmax je približno sorazmerno odmerku in znakov časovno odvisnega očistka ni.
The tablets should be taken whole, with food, in the evening or at bedtime.
Način uporabe Tablete Pelzont mora bolnik vzeti cele, s hrano, zvečer ali pred spanjem.
The starting dose is one modified-release tablet (1,000 mg nicotinic acid/20 mg laropiprant) once a day.
Začetni odmerek je ena tableta s prirejenim sproščanjem (1.000 mg nikotinske kisline/20 mg laropipranta) enkrat na dan.
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.
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.
Laropiprant was not mutagenic or clastogenic in a series of genetic toxicology studies.
Laropiprant v vrsti genetskih toksikoloških študij ni bi ne mutagen ne klastogen.
Like LDL, cholesterol-enriched triglyceride-rich lipoproteins, including VLDL, intermediate-density lipoproteins (IDL), and remnants, can also promote atherosclerosis.
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.
Pelzont: Use in patients with renal insufficiency has not been studied.
Pelzont: Uporaba pri bolnikih z ledvično insuficienco ni raziskana.
How Pelzont Works
Kako deluje zdravilo Pelzont
Fertility Animal studies are insufficient with respect to impairment on fertility (see section 5.3).
Plodnost Ni dovolj študij na živalih o vplivu zdravila na plodnost (glejte poglavje 5.3).
●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)
● Pelzont (1.000 mg/20 mg do 2.000 mg/40 mg 5. teden)
To preserve the modified-release properties, the tablets must not be split, broken, crushed, or chewed before swallowing.
Tablet s prirejenim sproščanjem se pred zaužitjem ne sme prelomiti, zdrobiti ali zgristi.
Opaque PVC/Aclar blister with push-through aluminium lidding containing 14 modified-release tablets.
Neprozoren pretisni omot iz PVC/Aclarja z aluminijskim prekritjem, skozi katerega se potisne tableta; omot vsebuje 14 tablet s prirejenim sproščanjem.
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.
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.
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.
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.
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.
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.
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].
(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].
In clinical trials, over 5,700 patients received Pelzont alone or with an HMG-CoA reductase inhibitor.
4.8 Neželeni učinki V kliničnih preskušanjih je zdravilo Pelzont samo ali skupaj z zaviralcem reduktaze HMG-CoA dobivalo več kot 5.700 bolnikov.
Like other lipid-lowering therapies, nicotinic acid medicinal products have been associated with abnormal liver function tests (see section 4.8).
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).
Over time, this plaque build-up can lead to a clogging of your arteries.
Naraščanje leh lahko sčasoma zoži arterije.
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.
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.
Toxicologic findings in these co-administration studies were consistent with those seen with nicotinic acid and laropiprant administered individually.
Toksikološki izsledki v teh študijah sočasne uporabe so se skladali z izsledki uporabe same nikotinske kisline in samega laropipranta.
There are no data from the combined use of nicotinic acid and laropiprant in pregnant women.
O kombinirani uporabi nikotinske kisline in laropipranta pri nosečnicah ni podatkov.
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.
Laropiprant Laropiprant se presnovi predvsem z acilglukuronidacijo, z manjšim deležem oksidativne presnove; temu sledi izločanje glukuronida v blatu (z žolčem) in urinu.
Nicotinic acid medicinal products have been associated with increases of fasting blood glucose levels (see section 4.8).
Zdravila z nikotinsko kislino so povezana z zvišanjem koncentracije glukoze v krvi na tešče (glejte poglavje 4.8).
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.
Ker ni bilo opaznega učinka pri hudi ledvični insuficienci, ga tudi pri blagi in zmerni insuficienci ni pričakovati.
Laropiprant crosses the placenta in rats and rabbits.
Laropiprant pri podganah in kuncih prehaja skozi placento.
Capsule-shaped, white to off-white tablet, with “552” debossed on one side.
tableta s prirejenim sproščanjem tablete v obliki kapsule in bele do kremaste barve z vtisnjeno oznako "552" na eni strani
Uncommon: myalgia Rare: muscular weakness
Redki: mišična šibkost
How to take Pelzont
Kako jemati zdravilo Pelzont
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.
Miši v tej študiji so (glede na mg/m2) dobivale približno 9- do 12-kratnik človeškega odmerka 2.000 mg nikotinske kisline na dan.
Common: abdominal pain; diarrhoea; dyspepsia; nausea; vomiting Rare: mouth oedema; eructation; peptic ulcer
Pogosti: bolečine v trebuhu; diareja; dispepsija; navzea; bruhanje Redki: edem ust; spahovanje; peptična razjeda
• Your doctor should do a blood test before you start taking Pelzont to check how well your liver is working.
• Pred začetkom uporabe zdravila Pelzont vas mora zdravnik poslati na preiskavo krvi, da bo preveril delovanje vaših jeter.
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).
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).
Laropiprant: No dose adjustment is necessary in the elderly.
Laropiprant: Pri starejših odmerjanja ni treba prilagoditi.
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).
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).
The mean volume of distribution at steady state following a single 40 mg intravenous dose of laropiprant to healthy subjects is approximately 70 litres.
Pri zdravih preiskovancih je povprečni volumen porazdelitve v stanju dinamičnega ravnovesja po posamičnem 40 mg intravenskem odmerku laropipranta približno 70 litrov.
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).
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.
Prolongation of collagen-induced platelet aggregation was observed in subjects taking multiple doses of 300 mg or greater (see section 5.1).
Pri preiskovancih, ki so jemali večkratne odmerke 300 mg ali več, so opazili podaljšanje s kolagenom izzvane agregacije trombocitov (glejte poglavje 5.1).
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).
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.
• See your doctor regularly to check your LDL (bad) and HDL (good) cholesterol levels and your triglyceride level.
• Redno obiskujte zdravnika, da boste preverili raven LDL holesterola (slabi holesterol), HDL