natgillin/translations-raw huggingface dataset:
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).
7 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).
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
Tako kot pri drugih zdravilih z nikotinsko kislino so v kontroliranih kliničnih študijah z zdravilom Tredaptive (2000 mg/ 40 mg) poročali o povišanju glukoze na tešče (mediano povišanje za 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).
Nicotinic acid-related adverse reactions The following nicotinic acid-related adverse reactions have been seen in clinical trials or post-marketing experience with other nicotinic acid medicinal products at unknown frequency or in clinical trials with Tredaptive (or the nicotinic acid component of Tredaptive) in < 1% of the patients treated:
Neželeni učinki, povezani z nikotinsko kislino Naslednje z nikotinsko kislino povezane neželene učinke so z neznano pogostnostjo opazili v kliničnih preskušanjih in med pomarketinško uporabo drugih zdravil z nikotinsko kislino ali pri < 1% zdravljenih bolnikov v kliničnih preskušanjih z zdravilom Tredaptive (ali nikotinskokislinsko sestavino zdravila Tredaptive):
Tredaptive In the event of an overdose, it is reasonable to employ the usual symptomatic and supportive measures.
Tredaptive V primeru prevelikega odmerjanja je smiselno uporabiti običajne simptomatske in podporne ukrepe.
Cases of overdose have been reported; the maximum dose of Tredaptive taken was 5000 mg/ 100 mg.
Opisani so primeri prevelikega odmerjanja; največji zaužiti odmerek zdravila Tredaptive je bil 5000 mg/ 100 mg.
5.1 Pharmacodynamic properties
8 5. 1 Farmakodinamične lastnosti
Tredaptive contains nicotinic acid, which at therapeutic doses is a lipid-modifying agent, and laropiprant, a potent, selective antagonist of the prostaglandin D2 (PGD2) receptor subtype 1 (DP1).
Tredaptive vsebuje nikotinsko kislino, ki v terapevtskih odmerkih vpliva na lipide, in laropiprant, močan, selektiven antagonist receptorja prostaglandina D2 (PGD2) podvrste 1 (DP1).
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 morda 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.
Treatment with nicotinic acid reduces the risk of death and cardiovascular events, and slows progression or promotes regression of atherosclerotic lesions.
Zdravljenje z nikotinsko kislino zmanjšuje tveganje za smrt in srčno- žilne dogodke ter upočasni napredovanje ali pripomore k nazadovanju aterosklerotičnih sprememb.
In healthy subjects receiving Tredaptive, pretreatment with acetylsalicylic acid 325 mg had no additional beneficial effects in reducing nicotinic acid-induced flushing symptoms compared to Tredaptive alone (see section 4.8).
Pri zdravih preiskovancih, ki so dobivali zdravilo Tredaptive, predhodna uporaba 325 mg acetilsalicilne kisline ni dodatno ublažila simptomov zardevanja zaradi nikotinske kisline v primerjavi s samim zdravilom Tredaptive (glejte poglavje 4. 8).
Laropiprant also has affinity for the thromboxane A2 receptor (TP) (although it is substantially less potent at TP as compared to DP1).
9 Laropiprant ima tudi afiniteto za receptor (TP) za tromboksan A2 (čeprav je za TP veliko manj močna kot za DP1).
Clinical studies Effect on lipids Tredaptive was consistently efficacious across all prespecified patient subpopulations defined by race, gender, baseline LDL-C, HDL-C and TG levels, age and diabetes status.
Klinične študije Učinek na lipide Tredaptive je učinkovit v zelo različnih populacijah odraslih bolnikov s primarno hiperholesterolemijo ali mešano dislipidemijo, ne glede na raso, spol, izhodiščno koncentracijo hLDL, hHDL in trigliceridov, ali glede na starost, pa tudi v posebnih populacijah, npr. pri sladkornih bolnikih.
4.3%) as measured by percent change from baseline.
Bolnikom, ki so jemali zdravilo Tredaptive 2000 mg/ 40 mg s statinom ali brez njega, so se v primerjavi s prejemniki placeba bistveno znižali hLDL (- 18, 9% v prim. z - 0, 5%), trigliceridi (- 21, 7% v prim. s 3, 6%), razmerje hLDL: hHDL (- 28, 9% v prim. z 2, 3%), ne- HDL- holesterol (- 19, 0% v prim. z 0, 8%), apo B (- 16, 4% v prim. z 2, 5%), Ch (- 9, 2% v prim. z - 0, 6%), Lp( a) (- 17, 6% v prim. z 1, 1%), in razmerje Ch: hHDL (- 21, 2% v prim. z 1, 9%), bistveno pa sta se jim zvišala hHDL (18, 8% v prim. z 1, 2%) in apo A- I (11, 2% v prim. s 4, 3%), merjeno v odstotkih spremembe od izhodišča.
Patients receiving Tredaptive, 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].
Bolniki, ki so dobivali zdravilo Tredaptive, nikotinsko kislino (pripravek s podaljšanim sproščanjem), ali placebo, so jemali tudi statine (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 a multicentre, double-blind, 12-week factorial study, Tredaptive 1000 mg/ 20 mg co-administered with simvastatin, when compared with simvastatin alone or Tredaptive 1000 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).
12, 5%).
Tredaptive (2000 mg/ 40 mg) co-administered with simvastatin when compared with simvastatin alone or Tredaptive (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
6, 0% oz.
11 (-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).
Kot je pokazala dodatna analiza, je sočasno s simvastatinom uporabljen Tredaptive 2000 mg/ 40 mg v primerjavi s samim simvastatinom bistveno zvišal apo A- I (8, 6% oz.
Further analysis showed Tredaptive (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).
0, 0%).
Flushing In two large clinical trials measuring patient-reported flushing symptoms, patients taking Tredaptive experienced less flushing than those taking nicotinic acid (prolonged-release formulations).
Zardevanje V dveh velikih kliničnih preskušanjih, ki sta ugotavljali simptome zardevanja po navedbi bolnikov, je bilo zardevanja manj med bolniki, ki so prejemali zdravilo Tredaptive, kot med bolniki, ki so prejemali nikotinsko kislino (pripravek s podaljšanim sproščanjem).
In patients continuing in the first study (24 weeks), the frequency of moderate or greater flushing in patients treated with Tredaptive 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).
Pri bolnikih, ki so dobivali nikotinsko kislino (pripravek s podaljšanim sproščanjem), pa se pogostnost zardevanja ni spremenila (po 6. tednu).
Figure 1.
10 Slika 1.
1
Število dni na teden 1
● Tredaptive (1000 mg/ 20 mg to 2000 mg/ 40 mg at week 5) ▲ Nicotinic acid (prolonged-release 1000 mg to 2000 mg at week 5) ○ Placebo *Includes patients with moderate, severe, or extreme flushing symptoms † Dose advancement at Week 5
● Tredaptive (1000 mg/ 20 mg do 2000 mg/ 40 mg 5. teden) ▲Nikotinska kislina (s podaljšanim sproščanjem, 1000 mg do 2000 mg 5. teden) ○ Placebo * Vključuje bolnike z zmernimi, hudimi ali izredno hudimi simptomi zardevanja † Povečanje odmerka 5. teden
In the second study (16 weeks) where acetylsalicylic acid was allowed, patients taking Tredaptive experienced significantly fewer days per week with moderate or greater flushing compared to nicotinic acid (prolonged-release formulation taken as a 12-week multi-step 500 mg to 2000 mg titration) (p < 0.001).
V drugi študiji (16 tednov), v kateri je bilo dovoljeno uporabljati acetilsalicilno kislino, so bolniki, ki so prejemali zdravilo Tredaptive, doživljali zmerno ali izrazitejše zardevanje statistično značilno manj dni na teden kot bolniki, ki so prejemali nikotinsko kislino (pripravek s podaljšanim sproščanjem, uporabljen v 12- tedenski večstopenjski titraciji od 500 mg do 2000 mg) (p < 0, 001).
Absorption Nicotinic acid Following a 2000 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 μ M·hr and a mean peak plasma concentration (Cmax) of approximately 20.2 μ M.
Absorpcija Nikotinska kislina Po peroralni uporabi 2. 000 mg nikotinske kisline v dveh tabletah nikotinske kisline/ laropipranta s prirejenim sproščanjem, zaužitih s hrano, je bil mediani čas do največje koncentracije nikotinske kisline v plazmi (tmax) 4 ure, povprečna površina pod krivuljo plazemske koncentracije v odvisnoti od časa (AUC0- last) približno 58, 0 µM· h in povprečna največja koncentracija v plazmi (Cmax) približno 20, 2 µM.
Laropiprant 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 μ M·hr, and a mean Cmax of approximately 1.6 μ M.
Laropiprant Po peroralni uporabi 40 mg laropipranta v dveh tabletah nikotinske kisline/ laropipranta s prirejenim sproščanjem, zaužitih s hrano, se laropiprant hitro absorbira; mediani tmax je 1 uro, povprečna AUC0- ∞ približno 13 µM· h in povprečna Cmax približno 1, 6 µM.
The rate and extent of absorption are not altered with a high-fat meal.
Farmakokinetika laropipranta je linearna.
Laropiprant The mean volume of distribution at steady state following a single 40 mg intravenous dose of laropiprant to healthy subjects is approximately 70 litres.
11 Pri zdravih preiskovancih je povprečni volumen porazdelitve v stanju dinamičnega ravnovesja po posamičnem 40- mg intravenskem odmerku laropipranta približno 70 litrov.
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 (5%).
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 Tredaptive:
Značilnosti pri bolnikih Insuficienca ledvic Tredaptive:
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.
Ker ni bilo opaznega učinka pri hudi insuficienci ledvic, ga tudi pri blagi in
Hepatic insufficiency Tredaptive:
Insuficienca jeter Tredaptive:
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.
Paediatric Tredaptive:
Pediatrični bolniki Tredaptive:
Tredaptive 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
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.
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.
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
16 6.2 Incompatibilities
14 magnezijev stearat
Not applicable.
6. 2 Inkompatibilnosti
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.
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.
EU/ 1/ 08/ 459/ 001 EU/ 1/ 08/ 459/ 002 EU/ 1/ 08/ 459/ 003 EU/ 1/ 08/ 459/ 004 EU/ 1/ 08/ 459/ 005 EU/ 1/ 08/ 459/ 006 EU/ 1/ 08/ 459/ 007
EU/ 1/ 08/ 459/ 001 EU/ 1/ 08/ 459/ 002 EU/ 1/ 08/ 459/ 003 EU/ 1/ 08/ 459/ 004 EU/ 1/ 08/ 459/ 005 EU/ 1/ 08/ 459/ 006 EU/ 1/ 08/ 459/ 007 EU/ 1/ 08/ 459/ 008 EU/ 1/ 08/ 459/ 009 EU/ 1/ 08/ 459/ 010
17 EU/ 1/ 08/ 459/ 008 EU/ 1/ 08/ 459/ 009 EU/ 1/ 08/ 459/ 010 EU/ 1/ 08/ 459/ 011 EU/ 1/ 08/ 459/ 012 EU/ 1/ 08/ 459/ 013 EU/ 1/ 08/ 459/ 014
15 EU/ 1/ 08/ 459/ 011 EU/ 1/ 08/ 459/ 012 EU/ 1/ 08/ 459/ 013 EU/ 1/ 08/ 459/ 014
Tredaptive 1000 mg/ 20 mg modified-release tablets Nicotinic acid/ laropiprant
Tredaptive 1000 mg/ 20 mg tablete s prirejenim sproščanjem nikotinska kislina/ laropiprant
EU/ 1/ 08/ 459/ 009 14 modified-release tablets EU/ 1/ 08/ 459/ 010 28 modified-release tablets EU/ 1/ 08/ 459/ 011 56 modified-release tablets EU/ 1/ 08/ 459/ 013 168 modified-release tablets EU/ 1/ 08/ 459/ 014 32 x 1 modified-release tablets
EU/ 1/ 08/ 459/ 009 14 tablet s prirejenim sproščanjem EU/ 1/ 08/ 459/ 010 28 tablet s prirejenim sproščanjem EU/ 1/ 08/ 459/ 011 56 tablet s prirejenim sproščanjem EU/ 1/ 08/ 459/ 013 168 tablet s prirejenim sproščanjem EU/ 1/ 08/ 459/ 014 32 x 1 tableta s prirejenim sproščanjem
Store in the original package in order to protect from light and moisture.
23 Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo in vlago.
EU/ 1/ 08/ 459/ 001 14 modified-release tablets EU/ 1/ 08/ 459/ 002 28 modified-release tablets EU/ 1/ 08/ 459/ 003 56 modified-release tablets EU/ 1/ 08/ 459/ 004 84 modified-release tablets EU/ 1/ 08/ 459/ 005 98 modified-release tablets EU/ 1/ 08/ 459/ 006 168 modified-release tablets EU/ 1/ 08/ 459/ 007 196 modified-release tablets EU/ 1/ 08/ 459/ 008 49 x 1 modified-release tablets EU/ 1/ 08/ 459/ 012 196 (2 packs of 98) modified-release tablets
EU/ 1/ 08/ 459/ 001 14 tablet s prirejenim sproščanjem EU/ 1/ 08/ 459/ 002 28 tablet s prirejenim sproščanjem EU/ 1/ 08/ 459/ 003 56 tablet s prirejenim sproščanjem EU/ 1/ 08/ 459/ 004 84 tablet s prirejenim sproščanjem EU/ 1/ 08/ 459/ 005 98 tablet s prirejenim sproščanjem EU/ 1/ 08/ 459/ 006 168 tablet s prirejenim sproščanjem EU/ 1/ 08/ 459/ 007 196 tablet s prirejenim sproščanjem EU/ 1/ 08/ 459/ 008 49 x 1 tableta s prirejenim sproščanjem EU/ 1/ 08/ 459/ 012 196 (2 zavoja po 98) tablet s prirejenim sproščanjem
Tredaptive 1000 mg/ 20 mg modified-release tablets nicotinic acid/ laropiprant
Tredaptive 1000 mg/ 20 mg tablete s prirejenim sproščanjem nikotinska kislina/ laropiprant
What Tredaptive is and what it is used for 2.
Kaj je zdravilo Tredaptive in za kaj ga uporabljamo 2.
Before you take Tredaptive 3.
Kaj morate vedeti, preden boste vzeli zdravilo Tredaptive 3.
How to take Tredaptive 4.
Kako jemati zdravilo Tredaptive 4.
How to store Tredaptive 6.
Shranjevanje zdravila Tredaptive 6.
WHAT TREDAPTIVE IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO TREDAPTIVE IN ZA KAJ GA UPORABLJAMO
Tredaptive is used in addition to diet • to lower your ‘ bad’ cholesterol level.
Zdravilo Tredaptive se uporablja poleg diete za: • znižanje "slabega" holesterola.
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.
Pri večini ljudi nenormalna raven holesterola sprva ne povzroča nobenih bolezenskih znakov.
Tredaptive 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.
29 Tredaptive 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.
Tredaptive can be used by itself or with other medicines to treat cholesterol problems.
Zdravilo Tredaptive se lahko uporablja sámo ali skupaj z drugimi zdravili za uravnavanje holesterola.
BEFORE YOU TAKE TREDAPTIVE
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO TREDAPTIVE
Do not take Tredaptive if • you are allergic (hypersensitive) to nicotinic acid, to laropiprant, or to any of the other ingredients of Tredaptive (listed in section 6). • you currently have liver problems. • you have an ulcer in your stomach. • you have arterial bleeding.
Ne jemljite zdravila Tredaptive: • če ste alergični na (preobčutljivi za) nikotinsko kislino, laropiprant ali katerokoli sestavino zdravila Tredaptive (naštete so v poglavju 6). • če imate trenutno težave z jetri. • če imate razjedo na želodcu. • če krvavite iz arterije.
Take special care with Tredaptive Tell your doctor about all of your medical conditions.
Bodite posebno pozorni pri jemanju zdravila Tredaptive Zdravniku morate povedati za vse svoje zdravstvene težave.
33 If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Tredaptive.
Če niste prepričani, ali kaj od naštetega velja za vas, se, preden vzamete zdravilo Tredaptive, posvetujte z zdravnikom ali s farmacevtom.
Blood tests and monitoring • See your doctor regularly to check your LDL (bad) and HDL (good) cholesterol levels and your triglyceride level. • Your doctor should do a blood test before you start taking Tredaptive to check how well your liver is working. • Your doctor may also want you to periodically have blood tests after you start taking Tredaptive, to check how well your liver is working and for other side effects.
Preiskave krvi in spremljanje • Redno obiskujte zdravnika, da boste preverili raven LDL holesterola (slabi holesterol), HDL holesterola (dobri holesterol) in trigliceridov. • Pred začetkom uporabe zdravila Tredaptive vas mora zdravnik poslati na preiskavo krvi za ugotavljanje delovanja jeter. • Morda vas bo zdravnik na preiskave krvi napotil tudi med zdravljenjem z zdravilom Tredaptive, da bo preveril delovanje jeter in druge neželene učinke.
Children and adolescents Tredaptive has not been studied in children and adolescents who are under 18 years of age.
30 Zdravilo Tredaptive ni raziskano pri otrocih in mladostnikih, mlajših od 18 let.
In particular, tell your doctor or pharmacist if you are taking any of the following: • medicines used to lower blood pressure. • medicines used to lower cholesterol called ‘ statins’, a class of medicine that works in the liver. • medicines used to lower cholesterol called ‘ bile acid sequestrants’, such as colestyramine. • zidovudine, a medicine used for HIV. • midazolam, a medicine to make you sleepy before some medical procedures. • vitamins or supplements that contain nicotinic acid. • clopidogrel, a medicine to help prevent harmful blood clots.
Še zlasti morate svojemu zdravniku ali farmacevtu povedati, če jemljete katero od naslednjih zdravil: • zdravila za zniževanje krvnega tlaka. • zdravila za zniževanje holesterola, ki jih imenujemo "statini"; statini so skupina zdravil, ki delujejo v jetrih. • zdravila za zniževanje holesterola, ki jih imenujemo "adsorbenti žolčnih kislin", npr. holestiramin. • zidovudin, ki je zdravilo za HIV. • midazolam, ki je zdravilo za uspavanje pred nekaterimi zdravstvenimi posegi. • vitamine ali dodatke, ki vsebujejo nikotinsko kislino. • klopidogrel, ki je zdravilo za preprečevanje škodljivih krvnih strdkov.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Tredaptive.
Če niste prepričani, ali kaj od naštetega velja za vas, se, preden vzamete zdravilo Tredaptive, posvetujte z zdravnikom ali s farmacevtom.
Taking Tredaptive with food and drink • Take Tredaptive with food. • To lower your chance of flushing, avoid drinking alcohol or hot drinks near the time you take your dose of Tredaptive. • It is important to follow the advice given in section 3 How to take Tredaptive.
Jemanje zdravila Tredaptive skupaj s hrano in pijačo • Zdravilo Tredaptive jemljite skupaj s hrano. • Da zmanjšate možnost zardevanja, v času zaužitja zdravila Tredaptive (ter malo pred tem in po tem) ne pijte alkohola ali vročih pijač. • Pomembno je, da upoštevate navodila v poglavju 3 Kako jemati zdravilo Tredaptive.