natgillin/translations-raw huggingface dataset:
In urine, the primary component is the acyl glucuronide conjugate (64% of radioactivity) with smaller contributions from the parent compound (5%).
V urinu je glavna z zdravilom povezana snov acilglukuronidni konjugat (64% radioaktivnosti), z manjšim prispevkom matične spojine
Elimination Nicotinic acid Nicotinic acid is predominantly excreted in the urine as metabolites.
Izločanje Nikotinska kislina Nikotinska kislina se v glavnem izloči v urinu v obliki presnovkov.
Laropiprant Laropiprant is eliminated primarily via acyl glucuronidation, followed by excretion of the glucuronide in faeces (via bile) and urine.
Laropiprant Laropiprant se odstrani predvsem z acilglukuronidacijo, sledi pa izločanje glukuronida v blatu (z žolčem) in urinu.
Following oral administration of 14C-laropiprant in humans, 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).
Pharmacokinetic steady state is achieved within 2 days of once-daily dosing of laropiprant, with minimal accumulation in AUC (approximately 1.3-fold) and Cmax (approximately 1.1-fold).
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. farmakokinetično stanje dinamičnega ravnovesja je doseženo v 2 dneh uporabe laropipranta enkrat na dan z minimalnim porastom AUC (približno 1, 3- krat) in Cmax (približno 1, 1- krat).
Characteristics in patients Renal insufficiency Pelzont:
Značilnosti pri bolnikih Insuficienca ledvic Pelzont:
Use in patients with renal insufficiency has not been studied.
Uporaba pri bolnikih z insuficienco ledvic ni raziskana.
Nicotinic acid: see section 4.4.
Nikotinska kislina: glejte poglavje 4. 4.
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.
Pri bolnikih s hudo insuficienco ledvic, ki niso bili na dializi, uporaba 40 mg laropipranta ni klinično pomembno spremenila AUC in Cmax laropipranta v primerjavi z zdravimi kontrolnimi osebami.
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.
Vendar pa na podlagi te študije ni mogoče sklepati, kako na farmakokinetiko laropipranta vplivata končna odpoved ledvic in dializa.
Hepatic insufficiency Pelzont:
Insuficienca jeter Pelzont:
Use in patients with hepatic insufficiency has not been studied.
Uporaba pri bolnikih z insuficienco jeter ni raziskana.
Nicotinic acid: see sections 4.3 and 4.4.
Nikotinska kislina: glejte poglavji 4. 3 in 4. 4.
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.
AUC se poveča približno 2, 8- krat in Cmax približno 2, 2- krat.
14 Gender Nicotinic acid:
Spol Nikotinska kislina:
No dose adjustment is necessary based on gender.
Odmerka ni treba prilagoditi glede na spol.
No dose adjustment is necessary based on gender.
Odmerjanja ni treba prilagoditi glede na spol.
Elderly Nicotinic acid:
Starejši Nikotinska kislina:
There is no pharmacokinetic data in the elderly (≥ 65 years).
Farmakokinetičnih podatkov za starejše (≥ 65 let) ni.
No dose adjustment is necessary in the elderly.
Pri starejših odmerjanja ni treba prilagoditi.
Paediatric Pelzont:
Pediatrični bolniki Pelzont:
No studies have been performed in paediatric patients.
Študij pri pediatričnih bolnikih niso izvedli.
Race Nicotinic acid:
Rasa Nikotinska kislina:
No dose adjustment is necessary based on race.
Odmerka ni treba prilagoditi glede na raso.
No dose adjustment is necessary based on race.
Odmerjanja ni treba prilagoditi glede na raso.
Pelzont Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure, indicating little relevance to human use.
To kaže na majhen pomen za uporabo pri ljudeh.
Nicotinic acid Degeneration in the stomach and hepatocyte vacuolation were observed in rats following 6 months of dosing at systemic exposure values at least 179 times the human exposure based on the AUC of the recommended daily human dose.
Nikotinska kislina Pri podganah so po 6- mesečni uporabi pri sistemski izpostavljenosti, ki je bila na podlagi AUC vsaj 179- krat večja od izpostavljenosti med uporabo priporočenega dnevnega odmerka pri človeku, opažali degeneracijo v želodcu in vakuolacijo.
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.
15 Nicotinic acid was not carcinogenic in mice when administered for the duration of their life.
Nikotinska kislina ni bila kancerogena pri miših, ki so jo dobivale vse življenje.
Mice in this study received approximately 9 to 13 times a human nicotinic acid dose of 2000 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 2000 mg nikotinske kisline na dan.
No studies are available on possible effects of high dose nicotinic acid on fertility or on postnatal development after in utero exposure.
Ustreznih podatkov o možnih učinkih visokih odmerkov nikotinske kisline na sposobnost razmnoževanja in na postnatalni razvoj ni.
Nicotinic acid induced reproduction toxic effects in rats when dosed at 1000 mg/ kg/ day during days 5-16 of gestation.
Nikotinska kislina je povzročila toksične učinke na sposobnost razmnoževanja pri podganah, ki so nikotinsko kislino prejemale 5. - 16. dan brejosti v odmerkih 1000 mg/ kg/ dan.
Decreased placental and fetal weights were observed.
Opazili so zmanjšano težo posteljice in ploda.
Laropiprant Ketonuria and hepatocellular centrilobular hypertrophy were observed in rats in repeated dose toxicity studies for up to 6 months dosing.
Laropiprant Pri podganah so v študijah toksičnosti ponavljajočih se odmerkov med uporabo do 6 mesecev opažali ketonurijo in centrilobularno hipertrofijo jetrnih celic.
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.
Raven brez ugotovljenih neželenih učinkov (NOAEL) je bila vsaj 118- krat tolikšna, kot je (na podlagi AUC) izpostavljenost med uporabo priporočenega dnevnega odmerka pri človeku.
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, ki je bila vsaj 14- krat tolikšna, kot je (na podlagi AUC) izpostavljenost med uporabo priporočenega dnevnega odmerka pri človeku.
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.
14 podlagi AUC) med uporabo priporočenega dnevnega odmerka pri človeku, niso opazili nobenih drugih učinkov.
Laropiprant was not carcinogenic in 2 year studies in mice and rats at the highest doses tested, which represents at least 218 to 289 times the human exposure based on the AUC of the recommended daily human dose.
289- krat tolikšno izpostavljenost, kot je (na podlagi AUC) izpostavljenost med uporabo priporočenega dnevnega odmerka pri človeku.
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.
Laropiprant was not teratogenic in rats or in rabbits at least 153 and 438 times the human exposure based on the AUC of the recommended daily human dose.
438- krat tolikšna, kot je (na podlagi AUC) izpostavljenost med uporabo priporočenega dnevnega odmerka pri človeku.
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.
Hypromellose (E464) Colloidal anhydrous silica (E551) Sodium stearyl fumarate Hydroxypropylcellulose (E463) Microcrystalline cellulose (E460) Croscarmellose sodium Lactose monohydrate Magnesium stearate
hipromeloza (E464) brezvoden koloidni silicijev dioksid (E551) natrijev stearilfumarat hidroksipropilceluloza (E463) mikrokristalna celuloza (E460) natrijev karmelozat, premreženi laktoza monohidrat magnezijev stearat
16 6.2 Incompatibilities
6. 2 Inkompatibilnosti
PVC/ Aclar blisters:
Pretisni omoti iz PVC/ Aclarja:
Aluminium/ Aluminium blisters:
Aluminijsko/ aluminijski pretisni omoti:
Opaque PVC/ Aclar blister with push-through aluminium lidding containing 14 modified-release tablets.
15 Neprozoren pretisni omot iz PVC/ Aclarja z aluminijskim prekritjem, skozi katerega se potisne tableta; omot vsebuje 14 tablet s prirejenim sproščanjem.
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.
14, 28, 56, 84, 98, 168, 196 tablet s prirejenim sproščanjem, multi pakiranje po 196 (2 zavoja po 98) tablet s prirejenim sproščanjem ter 49 x 1 tableta s prirejenim sproščanjem v perforiranem pretisnem omotu za enkratni odmerek.
Aluminium/ Aluminium blister with push-through lidding containing 7 modified-release tablets.
Aluminijsko/ aluminijski pretisni omot s prekritjem, skozi katerega se potisne tableta; omot vsebuje 7 tablet s prirejenim sproščanjem.
Pack sizes of 14, 28, 56, 168 modified-release tablets and 32 x 1 modified-release tablets in a perforated unit dose blister.
14, 28, 56, 168 tablet s prirejenim sproščanjem ter 32 x 1 tableta s prirejenim sproščanjem v perforiranem pretisnem omotu za enkratni odmerek..
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http: // www. emea. europa. eu /.
18 ANNEX II
16 DODATEK II
Shotton Lane Cramlington Northumberland NE23 3JU United Kingdom
Shotton Lane Cramlington Northumberland NE23 3JU Velika Britanija
The MAH must ensure that the system of pharmacovigilance, as described in version 3 dated September 2007 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora pred začetkom trženja zdravila vzpostaviti sistem farmakovigilance, kot je opisan v različici 3 v modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom sprejete septembra 2007, in ga vzdrževati ves čas trženja zdravila.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3.1 dated 23 April 2008 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Načrt za obvladovanje tveganja Imetnik dovoljenja za promet z zdravilom mora izvesti študije in dodatne farmakovigilančne aktivnosti, ki so podrobno opisane v načrtu farmakovigilance, sprejetem 23. aprila 2008 v različici 3. 1 načrta za obvladovanje tveganja (RMP) v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom in vse naknadne dopolnitve načrta za obvladovanje tveganja v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
20 ANNEX III
18 DODATEK III
22 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
20 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON (for Alu/ Alu blister)
Škatla (z Alu/ alu pretisnimi omoti)
Pelzont 1000 mg/ 20 mg modified-release tablets Nicotinic acid/ laropiprant
Pelzont 1000 mg/ 20 mg tablete s prirejenim sproščanjem nikotinska kislina/ laropiprant
14 modified-release tablets 28 modified-release tablets 56 modified-release tablets 168 modified-release tablets 32 x 1 modified-release tablets
14 tablet s prirejenim sproščanjem 28 tablet s prirejenim sproščanjem 56 tablet s prirejenim sproščanjem 168 tablet s prirejenim sproščanjem 32 x 1 tableta s prirejenim sproščanjem
Do not store above 30°C.
21 Shranjujte pri temperaturi do 30 °C.
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 EU/ 1/ 08/ 460/ 013 168 tablet s prirejenim sproščanjem EU/ 1/ 08/ 460/ 014 32 x 1 tableta s prirejenim sproščanjem
24 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
22 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON (for PVC/ Aclar blister)
Škatla (s PVC/ Aclar pretisnimi omoti)
14 modified-release tablets 28 modified-release tablets 56 modified-release tablets 84 modified-release tablets 98 modified-release tablets 168 modified-release tablets 196 modified-release tablets Multi-pack containing 196 (2 packs of 98) modified-release tablets 49 x 1 modified-release tablets
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 Multi pakiranje po 196 (2 zavoja po 98) tablet s prirejenim sproščanjem 49 x 1 tableta s prirejenim sproščanjem
EXP
23 Uporabno do:
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/ 001 14 tablet s prirejenim sproščanjem EU/ 1/ 08/ 460/ 002 28 tablet s prirejenim sproščanjem EU/ 1/ 08/ 460/ 003 56 tablet s prirejenim sproščanjem 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 EU/ 1/ 08/ 460/ 008 49 x 1 tableta s prirejenim sproščanjem EU/ 1/ 08/ 460/ 012 196 (2 zavoja po 98) tablet s prirejenim sproščanjem
27 PARTICULARS TO APPEAR ON THE INTERMEDIATECARTON
24 PODATKI NA SEKUNDARNI OVOJNINI
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 PVC/ Aclar pretisnimi omoti)
Component of a multi-pack comprising 2 packs, each containing 98 modified-release tablets.
98 tablet s prirejenim sproščanjem, kot del multi pakiranja z 2 enakima zavojema
29 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
26 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Pelzont 1000 mg/ 20 mg modified-release tablets nicotinic acid/ laropiprant
Pelzont 1000 mg/ 20 mg tablete s prirejenim sproščanjem nikotinska kislina/ laropiprant
even if their symptoms are the same as yours.
čeprav imajo znake bolezni, podobne vašim.
What Pelzont is and what it is used for 2.
Kaj je zdravilo Pelzont in za kaj ga uporabljamo 2.
Before you take Pelzont 3.
Kaj morate vedeti, preden boste vzeli zdravilo Pelzont 3.
How to take Pelzont 4.
Kako jemati zdravilo Pelzont 4.
How to store Pelzont 6.
Shranjevanje zdravila Pelzont 6.
WHAT PELZONT IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO PELZONT IN ZA KAJ GA UPORABLJAMO
The name of your medicine is Pelzont.
Vaše zdravilo se imenuje Pelzont.
It contains two different active substances: • nicotinic acid, a lipid modifying medicine, and • laropiprant, which reduces symptoms of flushing, a common side effect of nicotinic acid.
Vsebuje dve zdravilni učinkovini: • nikotinsko kislino, ki je zdravilo z vplivom na maščobe (lipide) in • laropiprant, ki zmanjša simptome zardevanja, pogostega neželenega učinka nikotinske kisline.
This means one or more active substances are released slowly over a period of time.
To pomeni, da se zdravilni učinkovini iz tablet počasi sproščata daljši čas.
Pelzont is used in addition to diet • to lower your ‘ bad’ cholesterol level.
Zdravilo Pelzont se uporablja poleg diete za: • znižanje "slabega" holesterola.
It does this by lowering the levels of total cholesterol, LDL cholesterol, fatty substances called triglycerides and apo B (a part of LDL) in the blood; • to raise levels of ‘ good’ cholesterol (HDL cholesterol) and apo A-I (a part of HDL).
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). • zvišanje "dobrega" holesterola (HDL holesterola) in apo A- I (ki je del HDL).
What should I know about cholesterol?
Kaj morate vedeti o holesterolu?
Your total cholesterol is made up mainly of ‘ bad’ (LDL) and ‘ good’ (HDL) cholesterol.
Celotni holesterol v glavnem sestavljata "slabi" holesterol (LDL) in "dobri" holesterol (HDL).
LDL cholesterol is often called ‘ bad’ cholesterol because it can build up in the walls of your arteries and form plaque.
LDL holesterol pogosto imenujemo "slabi" holesterol, ker se lahko kopiči v stenah arterij in tako povzroči nastanek leh.
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" holesterola v arterijah in ker varuje pred boleznijo srca.
32 In most people, at first there are no signs of cholesterol problems.
29 Pri večini ljudi nenormalna raven holesterola sprva ne povzroča nobenih bolezenskih znakov.
Pelzont is used if you need to improve cholesterol and fat levels in your blood (primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia): • when you cannot control your cholesterol levels with a statin (class of cholesterol-lowering medicines working in the liver); • when you cannot tolerate a statin or when a statin is not recommended for you.
Pelzont ste dobili, če morate izboljšati raven holesterola in maščob v krvi (primarna hiperholesterolemija (heterozigotna družinska in nedružinska) ali mešana dislipidemija): • če holesterola ne morete obvladati z enim od statinom (statini so skupina zdravil za zniževanje holesterola, ki delujejo v jetrih). • če statinov ne prenesete ali za vas niso priporočljivi.
Pelzont can be used by itself or with other medicines to treat cholesterol problems.
Zdravilo Pelzont se lahko uporablja sámo ali skupaj z drugimi zdravili za uravnavanje holesterola.
You should stay on a diet designed to lower cholesterol or other non-pharmacological treatments (e. g. exercise, weight reduction) while you take this medicine.
Med jemanjem zdravila morate nadaljevati z dieto ali drugimi ukrepi za zniževanje holesterola (npr. telesna vadba, zniževanje telesne mase).
BEFORE YOU TAKE PELZONT
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO PELZONT
Do not take Pelzont if • you are allergic (hypersensitive) to nicotinic acid, to laropiprant, or to any of the other ingredients of Pelzont (listed in section 6). • you currently have liver problems. • you have an ulcer in your stomach. • you have arterial bleeding.
Ne jemljite zdravila Pelzont: • če ste alergični na (preobčutljivi za) nikotinsko kislino, laropiprant ali katerokoli sestavino zdravila Pelzont (naštete so v poglavju 6). • če imate trenutno težave z jetri. • če imate razjedo na želodcu. • če krvavite iz arterije.
Take special care with Pelzont Tell your doctor about all of your medical conditions.
Bodite posebno pozorni pri jemanju zdravila Pelzont Zdravniku morate povedati za vse svoje zdravstvene težave.
Check with your doctor or pharmacist before and while taking your medicine if: • you have any allergies. • you have ever had liver disease, jaundice (a liver disorder causing yellowing of the skin and whites of the eyes), or hepatobiliary (liver and bile duct) disease. • you have kidney problems. • you have thyroid problems. • you drink large amounts of alcohol. • you or close family members have a hereditary muscle disorder, or you have ever had muscle problems during treatment with cholesterol-lowering medicines called “ statins” or fibrates. • you have unexplained muscle pain, muscle tenderness, or muscle weakness.
Preden vzamete in če že jemljete zdravilo, se posvetujte z zdravnikom ali s farmacevtom: • če imate kakšne alergije. • če ste kdaj imeli bolezen jeter, zlatenico (bolezen jeter, ki povzroči porumenitev kože in očesne beločnice) ali bolezni jeter in žolčnih vodov. • če imate težave z ledvicami. • če imate težave s ščitnico. • če pijete veliko alkohola. • če imate vi ali vaš ožji družinski član dedno bolezen mišic, ali ste kdaj tekom zdravljenja z zdravili za zniževanje holesterola, imenovanimi statini ali fibrati, imeli težave z mišicami. • če imate nepojasnjene bolečine v mišicah, občutljive ali šibke mišice.
If you have these symptoms talk to your doctor immediately. • you have high blood sugar or diabetes. • you have heart problems. • you are going to have an operation. • you have gout. • you have low levels of phosphorus. • you are over 70 years old.
Če imate katerega od teh simptomov, se takoj posvetujte z zdravnikom. • če imate visok krvni sladkor ali sladkorno bolezen. • če imate težave s srcem. • če imate predvideno operacijo. • če imate protin. • če imate nizko raven fosforja. • če ste starejši od 70 let.
33 If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Pelzont.
Če niste prepričani, ali kaj od naštetega velja za vas, se, preden vzamete zdravilo Pelzont, posvetujte z zdravnikom ali s farmacevtom.