natgillin/translations-raw huggingface dataset:
Concomitant therapy Acetylsalicylic acid provides no additional reduction of flushing beyond that achieved by Pelzont.
Sočasna zdravila Acetilsalicilna kislina zardevanja ne zmanjša nič bolj, kot ga že Pelzont.
Therefore, treatment with acetylsalicylic acid to alleviate flushing symptoms is not necessary (see section 5.1).
Zato za ublažitev simptomov zardevanja ni treba uporabljati acetilsalicilne kisline (glejte poglavje 5. 1).
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).
Zato je zdravilo Pelzont priporočljivo uporabiti več kot 1 uro pred adsorbenti žolčnih kislin ali več kot 4 ure po njih (glejte poglavje 4. 5).
• Hypersensitivity to the active substances or to any of the excipients. • Significant or unexplained hepatic dysfunction. • Active peptic ulcer disease. • Arterial bleeding.
• Preobčutljivost za zdravilni učinkovini ali katerokoli pomožno snov. • Pomembna ali nepojasnjena motnja delovanja jeter. • Aktivna peptična ulkusna bolezen. • Arterijska krvavitev.
When Pelzont is co-administered with a statin, please refer to the Summary of Product Characteristics for that particular medicinal product.
Če zdravilo Pelzont uporabite s statinom, morate upoštevati Povzetek glavnih značilnosti za to zdravilo.
Hepatic effects Switching from immediate-release (crystalline) nicotinic acid to Pelzont has not been studied.
Učinki na jetra Prehod z nikotinske kisline s takojšnjim sproščanjem (kristalne nikotinske kisline) na zdravilo Pelzont ni raziskan.
3 patients who have switched from immediate-release nicotinic acid to long-acting nicotinic acid at equivalent doses.
Vendar pa so se pri bolnikih, ki so z nikotinske kisline s takojšnjim sproščanjem prešli na njeno dolgodelujočo obliko v enakem odmerku, pojavili hudi toksični učinki na jetra (vključno s fulminantno nekrozo jeter).
Therefore, patients switching from immediate-release nicotinic acid to Pelzont should be initiated at the 1000 mg/ 20 mg dose.
Zato morate pri bolnikih, ki na zdravilo Pelzont preidejo z nikotinske kisline s takojšnjim sproščanjem, na začetku uporabiti odmerek 1000 mg/ 20 mg.
Pelzont should be used with caution in patients who consume substantial quantities of alcohol and/ or have a past history of liver disease.
Zdravilo Pelzont morate previdno uporabljati pri bolnikih, ki pijejo veliko alkohola in/ ali imajo bolezni jeter v anamnezi.
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 lahko tudi zdravila z nikotinsko kislino spremljajo nenormalni izvidi testov jetrnega delovanja (glejte poglavje 4. 8).
Liver function tests are recommended before initiation, every 6 to 12 weeks for the first year, and periodically (e. g. semi-annually) thereafter.
3 Teste delovanja jeter je priporočljivo opraviti pred začetkom zdravljenja, nato na 6 do 12 tednov prvo leto, pozneje pa občasno (npr. na pol leta).
Patients who develop increased transaminase levels should be monitored until the abnormalities have resolved.
Če se transaminaze zvišajo, morate bolnika kontrolirati, dokler nepravilnosti ne izginejo.
Should an increase in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of ≥ 3 X ULN persist, reduction of dose or withdrawal of Pelzont is recommended.
Če vrednosti alanin aminotransferaze (ALT) ali aspartat aminotransferaze (AST), večje ali enake 3- kratni ZMN (zgornja meja normalne vrednosti), trajajo, je priporočljivo zmanjšati odmerek zdravila Pelzont ali pa zdravilo Pelzont prenehati uporabljati.
Effect on skeletal muscle Rare cases of rhabdomyolysis have been associated with concomitant administration of lipid-altering doses (≥ 1000 mg/ day) of nicotinic acid and HMG-CoA reductase inhibitors (statins) (see section 4.8).
Vpliv na skeletne mišice Med sočasno uporabo nikotinske kisline v odmerkih, ki vplivajo na lipide (≥ 1000 mg/ dan), in zaviralcev reduktaze HMG- CoA (statinov) se je v redkih primerih pojavila rabdomioliza.
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.
Poleg tega morate bolnika natančno nadzirati glede mišičnih bolečin, občutljivosti ali šibkosti mišic, še posebej v prvih mesecih zdravljenja in ob povečanju odmerka enega ali drugega zdravila.
Caution should be exercised in patients with pre-disposing factors for rhabdomyolysis. • Age > 70 years • Renal impairment • Uncontrolled hypothyroidism • Personal or familial history of hereditary muscular disorders • Previous history of muscular toxicity with a statin or fibrate • Alcohol abuse.
Previdnost je potrebna pri bolnikh z že obstoječimi dejavniki za pojav rabdomiolize: • starost nad 70 let, • okvara ledvic, • neurejen hipotiroidizem, • osebna ali družinska anamneza o dednih boleznih mišic, • anamneza o toksičnih učinkih statinov ali fibratov na mišice, • zloraba alkohola.
Renal dysfunction Because nicotinic acid and its metabolites are excreted through the kidneys, Pelzont should be used with caution in patients with renal dysfunction.
Moteno delovanje ledvic Nikotinska kislina in njeni presnovki se izločajo skozi ledvice, zato morate pri bolnikih z motenim delovanjem ledvic zdravilo Pelzont uporabljati previdno.
Effect on glucose Nicotinic acid medicinal products have been associated with increases of fasting blood glucose levels (see section 4.8).
Vpliv na glukozo Zdravila z nikotinsko kislino so povezana z zvišanjem koncentracije glukoze v krvi na tešče (glejte poglavje 4. 8).
Diabetic or potentially diabetic patients should be observed closely.
Sladkorne bolnike in bolnike s potencialom za sladkorno bolezen morate natančno nadzirati.
Adjustment of diet and/ or hypoglycaemic therapy may be necessary.
Potrebna je lahko prilagoditev prehrane in/ ali antidiabetičnega zdravljenja.
4 Acute coronary syndrome 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.
Akutni koronarni sindrom 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.
Haematologic effects As with other nicotinic acid medicinal products, Pelzont (2000 mg/ 40 mg) was associated with small reductions in platelet count (see section 4.8).
Hematološki učinki Tako kot druga zdravila z nikotinsko kislino je bilo tudi zdravilo Pelzont (2000 mg/ 40 mg) povezano z majhnim zmanjšanjem števila trombocitov (glejte poglavje 4. 8).
Effect on uric acid As with other nicotinic acid medicinal products, Pelzont (2000 mg/ 40 mg) was associated with small increases in uric acid levels (see section 4.8).
Vpliv na sečno kislino Tako kot druga zdravila z nikotinsko kislino je bilo tudi zdravilo Pelzont (2000 mg/ 40 mg) povezano z majhnim zvišanjem sečne kisline (glejte poglavje 4. 8).
Therefore, patients with a risk for hypophosphatemia should be closely followed.
4 Hipofosfatemija 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.
Further 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).
Drugo Tako kot velja za druga zdravila z nikotinsko kislino, morate bolnike z anamnezo o zlatenici, boleznih jeter in žolčnika ali želodčni razjedi pozorno spremljati (glejte poglavji 4. 2 in 4. 3).
Excipient Pelzont contains lactose.
Pomožna snov Pelzont vsebuje laktozo.
Simultaneous use of alcohol or hot drinks can enhance the effects of flushing and should therefore be avoided around the time of ingestion of Pelzont.
Ko zaužijete zdravilo Tredaptiv, sočasno ne pitje alkohola ali vročih pijač, ker to lahko poslabša zardevanje.
Nicotinic acid Effects of nicotinic acid on other medicinal products Antihypertensive therapy:
Nikotinska kislina Učinki nikotinske kisline na druga zdravila Antihipertenzivna zdravila:
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.
Nikotinska kislina lahko poveča učinke ganglijskih zaviralcev in vazoaktivnih zdravil, kot so nitrati, zaviralci kalcijevih kanalov ali adrenergični zaviralci, in tako povzroči posturalno hipotenzijo.
HMG-CoA reductase inhibitors:
Zaviralci reduktaze HMG Co- A:
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.
Med uporabo simvastatina v kombinaciji z nikotinsko kislino sta se AUC in Cmax simvastatinske kisline (aktivne oblike simvastatina) zmerno zvišali, kar pa morda ni klinično pomembno.
The pharmacokinetic interaction of Pelzont with statins has been studied only with simvastatin (see section 4.4).
Izmed statinov, so farmakokinetične interakcije zdravila Pelzont raziskali samo s simvastatinom (glejte poglavje 4. 4).
Effects of other medicinal products on nicotinic acid Bile acid sequestrants:
Učinki drugih zdravil na nikotinsko kislino Adsorbenti žolčnih kislin:
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.
Zato je zdravilo Pelzont priporočljivo uporabiti več kot 1 uro pred adsorbenti žolčnih kislin ali več kot 4 ure po njih.
5 Supplements containing nicotinic acid:
Dodatki, ki vsebujejo nikotinsko kislino:
Vitamins or other nutritional supplements containing (≥ 50 mg/ day) of nicotinic acid (or nicotinamide) have not been studied with Pelzont.
Uporaba vitaminov in drugih prehranskih dopolnil, ki vsebujejo (≥ 50 mg/ dan) nikotinsko kislino (ali nikotinamid) hkrati z zdravilom Pelzont ni raziskana.
Medicinal product / laboratory test interactions:
Vpliv zdravila na laboratorijske preiskave:
In urine glucose tests, nicotinic acid may also give false-positive reactions with cupric sulfate solution (Benedict’ s reagent).
Pri preizkusih glukoze v urinu lahko nikotinska kislina povzroči lažno pozitivne reakcije z raztopino bakrovega sulfata (Benedictov reagent).
Laropiprant Effects of laropiprant on other medicinal products Midazolam:
Laropiprant Vplivi laropipranta na druga zdravila Midazolam:
Multiple doses of laropiprant 40 mg did not affect the pharmacokinetics of midazolam, a sensitive CYP3A4 substrate.
Večkratni odmerki 40 mg laropipranta niso vplivali na farmakokinetiko midazolama, ki je občutljiv substrat CYP3A4.
However, the plasma concentration of a metabolite of midazolam, 1'-hydroxymidazolam, was increased approximately 2-fold with multiple doses of laropiprant.
Toda koncentracija midazolamovega presnovka 1 '- hidroksimidazolama v plazmi se je med uporabo večkratnih odmerkov laropipranta povečala približno 2- krat.
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.
Zato je med uporabo laropipranta sočasno z midazolamom potrebna previdnost.
Other medicinal products:
5 Druga zdravila:
Co-administration of laropiprant 40 mg with midazolam increased the AUC0-∞ and Cmax of 1'-hydroxymidazolam, a midazolam metabolite, by 98% and 59%, respectively.
Sočasna uporaba 40 mg laropipranta z midazolamom je povečala AUC0- ∞ midazolamovega presnovka 1 '- hidroksimidazolama za 98% in njegovo Cmax za 59%.
1'-hydroxymidazolam is metabolised predominantly by uridine diphosphate-glucuronosyltransferases (UGT) 2B4 and 2B7.
1 '- hidroksimidazolam se presnavlja predvsem z uridindifosfat- glukuronoziltransferazama (UGT) 2B4 in 2B7.
Clinical and in vitro studies support the conclusion that laropiprant is a mild to moderate inhibitor of UGT2B4/ UGT2B7.
Klinične študije in študije in vitro potrjujejo, da laropiprant blago do zmerno zavira UGT2B4/ UGT2B7.
Very few medicinal products are known to be metabolised predominantly by UGT2B4 or UGT2B7.
Zelo malo je zdravil, ki se presnavljajo pretežno z UGT2B4 ali UGT2B7.
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, na primer z zidovudinom.
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 CYP ali človeškega glikoproteina P (P- gp).
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.
Klinična študija ni pokazala, da bi laropiprant vplival na klopidogrelovo zavrtje agregacije trombocitov, izzvane z ADP.
The clinical significance of these observations is unknown.
Zmerno pa se je povečalo klopidogrelovo zavrtje agregacije trombocitov, izzvane s kolagenom.
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).
V klinični študiji sočasna uporaba laropipranta in acetilsalicilne kisline v primerjavi z uporabo same acetilsalicilne kisline ni vplivala na agregacijo trombocitov, izzvano s kolagenom, ali na čas krvavitve (glejte poglavje 5. 1).
Effects of other medicinal products on laropiprant CYP3A4 Inhibitor:
Učinki drugih zdravil na laropiprant Zaviralec CYP3A4:
Clarithromycin (a potent inhibitor of CYP3A4 and P-gp) did not have a clinically meaningful effect on the pharmacokinetics of laropiprant.
Klaritromicin (močan zaviralec CYP3A4 in P- gp) ni klinično pomembno vplival na farmakokinetiko laropipranta.
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.
Laropiprant ni substrat človeškega P- gp, zato ni pričakovati, da bi drugi zaviralci CYP3A4 in/ ali P- gp klinično pomembno vplivali na farmakokinetiko laropipranta.
Pregnancy Pelzont There are no data from the combined use of nicotinic acid and laropiprant in pregnant women.
Pelzont O kombinirani uporabi nikotinske kisline in laropipranta pri nosečnicah ni podatkov.
Therefore, Pelzont should not be used during pregnancy unless clearly necessary.
Zato zdravila Pelzont ne smete uporabljati med nosečnostjo, razen če je to nujno.
Nicotinic acid There are no adequate data from the use of high dose nicotinic acid in pregnant women.
Nikotinska kislina O uporabi velikih odmerkov nikotinske kisline pri nosečnicah ni dovolj podatkov.
Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Študije na živalih ne zadostujejo za oceno vpliva na razmnoževanje.
Laropiprant There are no data from the use of laropiprant in pregnant women.
Laropiprant O uporabi laropipranta pri nosečnicah ni.
Studies in animals have shown reproductive toxicity at high doses of laropiprant (see section 5.3).
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja pri velikih odmerkih laropipranta (glejte poglavje 5. 3).
Lactation Pelzont No studies in lactating animals have been conducted with Pelzont.
Pelzont Pri doječih živalih študije z zdravilom Pelzont niso bile izvedene.
A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy should be made taking into account the benefit of breast-feeding to the child and the benefit of Pelzont to the woman.
Pri odločitvi za nadaljevanje ali prekinitev dojenja oz. za nadaljevanje ali prekinitev zdravljenja morate upoštevati korist dojenja za otroka in korist zdravila Pelzont za žensko.
Nicotinic acid Nicotinic acid is excreted in human breast milk.
Nikotinska kislina Nikotinska kislina se izloča v materino mleko pri človeku.
Animal studies have shown excretion of laropiprant in milk.
6 Laropiprant Študije na živalih so pokazale, da se laropiprant izloča v mleko, vendar ni znano, ali se laropiprant izloča v materino mleko pri človeku.
However, when driving vehicles or operating machines, it should be taken into account that dizziness has been reported (see section 4.8).
Vendar pa je treba pri vožnji oz. upravljanju s stroji upoštevati, da so poročali o omotici (glejte poglavje 4. 8).
4.8 Undesirable effects In clinical trials, over 2500 patients received Pelzont alone or with an HMG-CoA reductase inhibitor.
V kliničnih preskušanjih je zdravilo Pelzont sam ali skupaj z zaviralcem reduktaze HMG- CoA dobivalo več kot 2500 bolnikov.
Adverse reactions have usually been mild and transient.
Neželeni učinki so bili ponavadi blagi in prehodni.
Flushing Flushing is the most common adverse reaction of Pelzont.
Zardevanje Zardevanje je najpogostejši neželeni učinek zdravila Pelzont.
In a pool of four active- or placebo-controlled clinical trials (N=2548), flushing was reported by the investigator as a possibly, probably, or definitely treatment-related adverse reaction in 12.3% of patients taking Pelzont.
V štirih kliničnih preskušanjih (n = 2. 548), kontroliranih z učinkovino ali placebom, so raziskovalci zardevanje ocenili kot možno, verjetno ali zagotovo z zdravilom povezan neželen učinek pri 12, 3% bolnikov, ki so jemali Pelzont.
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.
Zaradi simptomov zardevanja (rdečica, toplota, srbenje in mravljinčenje) 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.
Discontinuations due to other specific adverse reactions among patients taking Pelzont were infrequent (< 1%).
Prekinitev uporabe zaradi drugih specifičnih neželenih učinkov je bila med uporabniki zdravila Pelzont redka (< 1%).
7 Overall adverse reactions with Pelzont In addition to flushing, clinical adverse reactions reported by the investigators as possibly, probably, or definitely related to Pelzont in ≥ 1% of patients treated with Pelzont alone (n=947) or co-administered with statin (n=1601) and clinically meaningful adverse reactions (< 1%), for up to one year are listed below.
Vsi neželeni učinki zdravil Pelzont Spodaj so našteti klinični neželeni učinki, ki so jih raziskovalci poleg zardevanja zabeležili kot možno, verjetno ali zagotovo povezane z zdravilom Pelzont pri ≥ 1% bolnikov, zdravljenih samo z zdravilom Pelzont (n = 945) ali hkrati s statinom (n = 1601), ter klinično pomembni neželeni učinki (< 1%) za obdobje do enega leta.
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).
Neželeni dogodki so po pogostnosti razvrščeni takole: zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100 do < 1/ 10), občasni (≥ 1/ 1. 000 do < 1/ 100), redki (≥ 1/ 10. 000 do < 1/ 1. 000), zelo redki (< 1/ 10. 000).
System organ class Investigations
Organski sistem Laboratorijski izvidi
Adverse reaction elevations in ALT and/ or AST (consecutive, ≥ 3 X ULN), fasting glucose, uric acid (see below)
Neželeni učinek povišanja ALT in/ ali AST (zaporedno, ≥ 3 x ZMN), glukoze na tešče, sečne kisline (glejte spodaj)
Frequency Common
Pogostnost pogosti
elevations in CK (≥ 10 X ULN), total bilirubin, reductions in phosphorus and platelet counts (see below)
povišanja CK (≥ 10 x ZMN), celotnega bilirubina, znižanje fosforja in števila trombocitov (glejte spodaj)
Nervous system disorders Gastrointestinal disorders Skin and subcutaneous tissue disorders
Bolezni živčevja Bolezni prebavil
dizziness, headache, paraesthesia diarrhoea, dyspepsia, nausea, vomiting erythema, pruritus, rash, urticaria
omotica, glavobol, parestezije driska, dispepsija, navzeja, bruhanje
Common Common Common
pogosti pogosti
Vascular disorders
Bolezni kože in podkožja
flushing
eritem, srbenje, izpuščaj, urtikarija
General disorders and administration site conditions
Žilne bolezni Splošne težave in spremembe na mestu aplikacije
feeling hot
zardevanje Občutek vročine
Common
zelo pogosti pogosti
Hypersensitivity reaction (see below)
Preobčutljivostne reakcije (glejte
Hypersensitivity reactions
Neželeni učinek spodaj)
An apparent hypersensitivity reaction has been reported (< 1%) 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.
Zabeležena je bila (< 1%) očitno preobčutljivostna reakcija, za katero so značilni različni simptomi, med drugim: angioedem, srbenje, eritem, parestezije, izguba zavesti, bruhanje, urtikarija, zardevanje, dispneja, navzeja, inkontinenca urina in blata, hladno znojenje, drgetanje, mrzlica, zvišan krvni tlak, otekanje ustnic, pekoč občutek, medikamentozen izpuščaj, artralgija, otekanje nog in tahikardija.
Investigations Marked and persistent increases of serum transaminases have been reported infrequently (see section 4.4).
Preiskave Redko so zabeležili izrazit in stalen porast serumskih transaminaz (glejte poglavje 4. 4).
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.
Med bolniki, ki so v kontroliranih kliničnih študijah uporabljali zdravilo Pelzont (s statinom ali brez njega), je bila incidenca klinično pomembnih zvišanj serumskih transaminaz (ALT in/ ali AST ≥ 3- krat ZMN, zaporedno) 1, 0%.
These elevations were generally asymptomatic and returned to baseline after discontinuation of therapy or with continued treatment.
Ta zvišanja so bila praviloma nesimptomatska in vrednosti so se po prenehanju zdravljenja ali med nadaljnjim zdravljenjem vrnile na izhodiščne.
Clinically important elevations of CK (≥ 10 X ULN) were seen in 0.3% of the patients treated with Pelzont with or without a statin (see section 4.4).
Klinično pomembno zvišanje CK (≥ 10- krat ZNM) se je pojavilo pri 0, 3% bolnikov, ki so dobivali zdravilo Pelzont s statinom ali brez njega (glejte poglavje 4. 4).
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 opisane laboratorijske nepravilnosti so bile zvišanje LDH, glukoze na tešče, sečne kisline, celotnega bilirubina in amilaze ter znižanje fosforja in števila trombocitov (glejte poglavje 4. 4).