natgillin/translations-raw huggingface dataset:
Physicians should consider the nicotinic acid intake from vitamins and nutritional supplements when prescribing Pelzont.
Pri predpisovanju zdravila Pelzont morate upoštevati vnos nikotinske kisline z vitamini in prehranskimi dopolnili.
There are no adequate data from the use of high dose nicotinic acid in pregnant women.
O uporabi velikih odmerkov nikotinske kisline pri nosečnicah ni dovolj podatkov.
Paediatric population Pelzont: No studies have been performed in paediatric patients.
Pelzont: Študij pri pediatričnih bolnikih niso izvedli.
Each tablet contains 1000 mg nicotinic acid and 20 mg laropiprant.
Vsaka tableta vsebuje 1.000 mg nikotinske kisline in 20 mg laropipranta.
If muscle pain, weakness or cramps occur while a patient is receiving Pelzont with a statin, their CK levels should be measured.
Če se med jemanjem zdravila Pelzont skupaj s statinom pojavijo bolečine v mišicah, oslabelost mišic ali mišični krči, je treba bolniku izmeriti raven CK.
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).
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
• Swallow each tablet whole.
• Tablete morate pogoltniti cele.
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.
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.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (for Alu/Alu blister)
PODATKI NA ZUNANJI OVOJNINI Škatla (z alu/alu pretisnimi omoti)
• upset stomach or heartburn
• razdražen želodec ali zgaga
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.
HDL holesterol pogosto imenujemo "dobri" holesterol, ker pomaga preprečevati kopičenje "slabega"
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).
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.
Nicotinic acid For an overdose of nicotinic acid, supportive measures should be employed.
V primeru prevelikega odmerjanja nikotinske kisline je treba uporabiti podporne ukrepe.
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 spremljati glede mišičnih bolečin, občutljivosti ali šibkosti mišic, še posebej v prvih mesecih zdravljenja in ob povečanju kateregakoli zdravila.
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).
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).
Uncommon: hypersensitivity reaction (see below) Rare: angio-oedema; type I hypersensitivity Not known: anaphylactic shock
Občasni: preobčutljivostne reakcije (glejte spodaj) Redki: angioedem; preobčutljivost tipa I
Each modified-release tablet contains 128.4 mg of lactose monohydrate.
Pomožne snovi z znanim učinkom: Ena tableta s prirejenim sproščanjem vsebuje 128,4 mg laktoze monohidrata.
Pelzont 1,000 mg/20 mg modified-release tablets nicotinic acid/laropiprant
Pelzont 1.000 mg/20 mg tablete s prirejenim sproščanjem nikotinska kislina/laropiprant
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.
(NOAEL) je bila vsaj 118-krat tolikšna, kot je (na podlagi AUC) izpostavljenost med uporabo priporočenega dnevnega odmerka pri človeku.
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.
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.
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).
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).
• Previous history of muscular toxicity with a statin or fibrate
• anamneza toksičnih učinkov statinov ali fibratov na mišice,
• you have gout.
• če imate protin.
Laropiprant suppresses PGD2 mediated flushing associated with administration of nicotinic acid.
Laropiprant zavira zardevanje zaradi PGD2, ki spremlja uporabo nikotinske kisline.
Laropiprant: No dose adjustment is necessary based on gender.
Laropiprant: Odmerjanja ni treba prilagoditi glede na spol.
Aluminium/Aluminium blisters: 18 months.
Pretisni omoti iz PVC/Aclarja: 2 leti Aluminijsko/aluminijski pretisni omoti: 18 mesecev
Studies in animals have shown foetal developmental toxicity at high doses of laropiprant (see section 5.3).
Študije na živalih so pokazale škodljive učinke na razvoj ploda pri velikih odmerkih laropipranta (glejte poglavje 5.3).
56 modified-release tablets
56 tablet s prirejenim sproščanjem
Therefore, patients switching from immediate-release nicotinic acid to Pelzont should be initiated at the 1,000 mg/20 mg dose.
Pri bolnikih, ki preidejo na zdravilo Pelzont z nikotinske kisline s takojšnjim sproščanjem, morate zdravljenje začeti z odmerkom 1.000 mg/20 mg.
The following adverse reactions have been reported during clinical studies and/or post-marketing use with Pelzont (with or without a statin).
V času kliničnih študij in/ali obdobju trženja zdravila Pelzont (z ali brez statina) so poročali o naslednjih neželenih učinkih.
Your total cholesterol is made up mainly of ‘bad' (LDL) and ‘good' (HDL) cholesterol.
Celotni holesterol v glavnem sestavljata "slabi" holesterol (LDL) in
Ketonuria and hepatocellular centrilobular hypertrophy were observed in rats in repeated dose toxicity studies for up to 6 months dosing.
Pri podganah so v študijah toksičnosti ponavljajočih se odmerkov med uporabo do 6 mesecev opažali ketonurijo in centrilobularno hipertrofijo jetrnih celic.
Studies in animals have shown foetal developmental toxicity at high doses of nicotinic acid (see section 5.3).
Študije na živalih so pokazale škodljive učinke na razvoj ploda pri velikih odmerkih nikotinske kisline (glejte poglavje 5.3).
No studies in lactating animals have been conducted with Pelzont.
Na doječih živalih študije z zdravilom Pelzont niso bile izvedene.
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.
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
Some people get dizzy after taking Pelzont.
Nekateri ljudje po zaužitju zdravila Pelzont postanejo omotični.
Triglycerides are another fat in your blood.
Druga vrsta maščob v krvi so trigliceridi.
Use of Pelzont in patients with hepatic or renal insufficiency has not been studied.
Bolniki z jetrno ali ledvično insuficienco Uporaba zdravila Pelzont pri bolnikih z jetrno ali ledvično insuficienco ni raziskana.
• Avoid drinking alcohol or hot drinks or eating spicy foods near the time you take your dose of Pelzont.
• Ne pijte alkohola ali vročih pijač in ne jejte začinjene hrane malo pred zaužitjem odmerka zdravila
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.
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.
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.
Klopidogrel: V klinični študiji laropiprant ni pomembno vplival na zaviranje z ADP izzvane agregacije trombocitov s klopidogrelom.
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)
Multi pakiranje po 196 (2 zavoja po 98 tablet s prirejenim sproščanjem) - brez blue box-a (s
Effect on uric acid
Vpliv na sečno kislino
• eye disorders called toxic amblyopia and cystoid macular oedema which may lead to blurred,
• očesnih boleznih, in sicer toksični ambliopiji in cistoidnem makularnem edemu, ki lahko povzročita zameglitev, zmanjšanost ali izgubo vida,
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).
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.
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.
Tako poveča razmerje HDL2:HDL3, kar je povezno z manjšim tveganjem za srčno-žilne bolezni.
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.
Ni pa zagotovila, da bo takšno spremljanje preprečilo pojav hude miopatije.
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.
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.
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).
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).
However, nicotinic acid a component of Pelzont does pass into breast milk.
Znano pa je, da v materino mleko prehaja nikotinska kislina, sestavina zdravila Pelzont.
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.
Da bo možnost zardevanja manjša, naj bolniki v času zaužitja zdravila ne pijejo alkoholnih pijač ali vročih napitkov in ne jedo začinjene hrane.
Nicotinic acid: No dose adjustment is necessary based on gender.
Spol Nikotinska kislina: Odmerka ni treba prilagoditi glede na spol.
Laropiprant: No dose adjustment is necessary based on race.
Laropiprant: Odmerjanja ni treba prilagoditi glede na raso.
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.
Zvišanje serumske alanin-aminotransferaze (ALT) so opažali v vseh študijah na psih pri izpostavljenosti,
flushing, headache, pruritus (itching), nausea, dizziness, vomiting, diarrhoea, abdominal pain/discomfort, and back pain.
zardevanje, glavobol, srbenje, siljenje na bruhanje, omotica, bruhanje, driska, bolečine/nelagodje v trebuhu, bolečine v hrbtu.
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 zdravilo Pelzont.
Multi-pack containing 196 (2 packs of 98) modified-release tablets 49 x 1 modified-release tablets
Multi pakiranje po 196 (2 pakiranji po 98) tablet s prirejenim sproščanjem
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).
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).
How to take
Kako morate jemati zdravilo
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.
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
Respiratory, thoracic, and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora Bolezni prebavil
Nicotinic acid Nicotinic acid is excreted in human breast milk.
Nikotinska kislina se izloča v materino mleko.
Pelzont contains lactose
Zdravilo Pelzont vsebuje laktozo
Laropiprant is eliminated primarily via acyl glucuronidation, followed by excretion of the glucuronide in faeces (via bile) and urine.
Laropiprant se odstrani predvsem z acilglukuronidacijo, sledi pa izločanje glukuronida v blatu (z žolčem)
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.
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).
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.
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.
As with other nicotinic acid medicinal products, Pelzont was associated with small decreases in phosphorus levels.
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.
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).
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
• swelling of the lips
• otekanje ustnic
• muscle weakness
• šibkost mišic
Effects of other medicinal products on laropiprant
Učinki drugih zdravil na nikotinsko kislino
Nicotinic acid: No dose adjustment is necessary based on race.
Rasa Nikotinska kislina: Odmerka ni treba prilagoditi glede na raso.
Diet and other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with Pelzont.
Med zdravljenjem z zdravilom Pelzont mora bolnik še naprej upoštevati dieto in druge nefarmakološke ukrepe zdravljenja (npr. telesno dejavnost, zmanjšanje telesne mase).
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.
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.
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
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
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.
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.
In particular, tell your doctor or pharmacist if you are taking any of the following:
Še zlasti morate svojemu zdravniku ali farmacevtu povedati, če jemljete katero od naslednjih zdravil: • zdravila za zniževanje krvnega tlaka.
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.
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.
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.
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.
Women have a modest increase in plasma concentrations of nicotinuric acid and nicotinic acid compared to men.
Koncentracija nikotinurične in nikotinske kisline v plazmi je pri ženskah zmerno večja kot pri moških.
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.
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.
Uncommon: chills; pain; peripheral oedema Rare: asthaenia; face oedema; generalised oedema
Redki: astenija; edem obraza; generaliziran edem
Gender had no clinically meaningful effect on the pharmacokinetics of laropiprant.
Spol na farmakokinetiko laropipranta ne vpliva klinično pomembno.
There is no change in the oral bioavailability of nicotinic acid with age.
Biološka uporabnost peroralno uporabljene nikotinske kisline se s starostjo ne spremeni.
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
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
• rapid heart rate.
• otekanje nog • hitro bitje srca
Pack sizes of 14, 28, 56, 168 modified-release tablets and 32 x 1 modified-release tablets in a perforated unit dose blister.
28, 56, 168 tabletami s prirejenim sproščanjem ter z 32 x 1 tableto s prirejenim sproščanjem v perforiranem pretisnem omotu za enkratni odmerek.
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.
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,
• getting sick (vomiting)
• slabost (bruhanje)
What you need to know before you take Pelzont
Kaj morate vedeti, preden boste vzeli zdravilo Pelzont Ne jemljite zdravila Pelzont:
4.9 Overdose
4.9 Preveliko odmerjanje Pelzont
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
• rash
• srbež
Pelzont contains lactose.
Zdravilo Pelzont vsebuje laktozo.
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.
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
• laropiprant, which reduces symptoms of flushing, a common side effect of nicotinic acid.
• nikotinsko kislino, ki je zdravilo z vplivom na maščobe (lipide) in • laropiprant, ki zmanjša simptome zardevanja, pogostega neželenega učinka nikotinske kisline.
• you have kidney problems.
• če imate težave z ledvicami.
Nervous system disorders
Psihiatrične motnje Bolezni živčevja
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.
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.