natgillin/translations-raw huggingface dataset:
29 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
31 PODATKI NA ZUNANJI OVOJNINI
32 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
34 PODATKI NA ZUNANJI OVOJNINI
34 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
36 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
What Trazec is and what it is used for 2.
Kaj je zdravilo Trazec in za kaj ga uporabljamo 2.
Before you take Trazec 3.
Kaj morate vedeti, preden boste vzeli zdravilo Trazec 3.
How to take Trazec 4.
Kako jemati zdravilo Trazec 4.
How to store Trazec 6.
Shranjevanje zdravila Trazec 6.
WHAT TRAZEC IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO TRAZEC IN ZA KAJ GA UPORABLJAMO
This helps to keep the blood sugar controlled after meals.
Trazec deluje tako, da spodbuja trebušno slinavko k hitrejšemu izdelovanju insulina, kar pomaga nadzorovati krvni sladkor po obrokih.
BEFORE YOU TAKE TRAZEC
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO TRAZEC
Do not take Trazec
Ne jemljite zdravila Trazec
- if you are allergic (hypersensitive) to nateglinide or any of the other ingredients of Trazec.
- če ste alergični na (preobčutljivi za) nateglinid ali katerokoli sestavino zdravila Trazec;
37 Take special care with Trazec People with diabetes sometimes get symptoms of low blood sugar (also called hypoglycaemia).
39 Bodite posebno pozorni pri jemanju zdravila Trazec Ljudje s sladkorno boleznijo včasih dobijo simptome znižanega krvnega sladkorja (imenuje se tudi hipoglikemija).
Food, drink and exercise Take Trazec before meals (see section 3, “ How to take Trazec”).
Hrana, pijača in telesna aktivnost Jemljite Trazec pred obroki (glejte poglavje 3, “ Kako jemati zdravilo Trazec ”).
Trazec and older people Trazec can be used by people over 65 years of age.
40 Trazec in starejši ljudje Trazec lahko uporabljajo tudi ljudje, starejši od 65 let.
38 Trazec and children and adolescents Trazec is not recommended for children and adolescents (under 18 years of age) because its effects in this age group have not been studied.
Trazec ter otroci in mladostniki Trazec ni priporočljiv za otroke in mladostnike (mlajše od 18 let), ker njegovih učinkov v tej starostni skupini niso proučevali.
Pregnancy and breast-feeding Do not take Trazec if you are pregnant or planning to become pregnant.
Nosečnost in dojenje Ne jemljite zdravila Trazec, če ste noseči ali če načrtujete zanositev.
HOW TO TAKE TRAZEC
KAKO JEMATI ZDRAVILO TRAZEC
Always take Trazec exactly as your doctor has told you.
Pri jemanju zdravila Trazec natančno upoštevajte zdravnikova navodila.
When to take Trazec Take Trazec before the three main meals, usually:
Kdaj jemljite Trazec Trazec zaužijte pred tremi glavnimi obroki, navadno:
How much to take Take Trazec as your doctor told you to.
Koliko jemati Jemljite Trazec, kot vam je naročil zdravnik.
How long to take Trazec Take Trazec daily until your doctor tells you to stop.
Kako dolgo jemati zdravilo Trazec Jemljite Trazec vsak dan, dokler vam zdravnik ne naroči, da ga prenehajte jemati.
If you take more Trazec than you should If you have accidentally taken too many tablets, talk to a doctor straight away.
41 Če ste vzeli večji odmerek zdravila Trazec, kot bi smeli Če ste pomotoma vzeli preveč tablet, se nemudoma posvetujte z zdravnikom.
If you forget to take Trazec If you forget to take a tablet simply take the next one before your next meal.
Če ste pozabili vzeti zdravilo Trazec Če pozabite vzeti tableto, preprosto vzemite naslednjo tableto pred naslednjim obrokom.
The expiry date refers to the last day of that month.
Ne uporabite Trazeca, če je ovojnina poškodovana ali kaže znake, da jo je nekdo že odprl.
Do not use any Trazec pack that is damaged or shows signs of tampering.
Shranjujte pri temperaturi do 30 °C.
40 6.
42 6.
- The active substance is nateglinide.
- Zdravilna učinkovina je nateglinid.
What Trazec looks like and contents of the pack Trazec 60 mg film-coated tablets are pink, round tablets with “ NVR” marked on one side and “ TS” on the other.
Izgled zdravila in vsebina pakiranja Trazec 60 mg filmsko obložene tablete so rožnate, okrogle tablete z oznako “ NVR ” na eni ter “ TS ” na drugi strani.
Trazec 120 mg film-coated tablets are yellow, ovaloid tablets with “ NVR” marked on one side and “ TSL” on the other.
Trazec 120 mg filmsko obložene tablete so rumene, ovalne tablete z oznako “ NVR ” na eni ter “ TSL ” na drugi strani.
Trazec 180 mg film-coated tablets are red, ovaloid tablets with “ NVR” marked on one side and “ TSX” on the other.
Trazec 180 mg filmsko obložene tablete so rdeče, ovalne tablete z oznako “ NVR ” na eni ter “ TSX ” na drugi strani.
Deutschland Novartis Pharma GmbH Tel: +49 911 273 0
43 Deutschland Novartis Pharma GmbH Tel: +49 911 273 0
Tredaptive is a medicine containing two active substances: nicotinic acid (also known as niacin or vitamin B3) and laropiprant.
Tredaptive je zdravilo, ki vsebuje dve aktivni učinkovini: nikotinsko kislino (znano tudi kot niacin ali vitamin B3) in laropiprant.
Tredaptive is used in addition to diet and exercise in patients with dyslipidaemia (abnormally high levels of fat in the blood), particularly ‘ combined mixed dyslipidaemia’ and ‘ primary hypercholesterolaemia’.
Zdravilo Tredaptive se uporablja kot dodatek k prehrani in telesni vadbi pri bolnikih z dislipidemijo (nenormalno visoka raven maščobe v krvi), zlasti pri tistih s kombinirano mešano dislipidemijo in primarno hiperholesterolemijo.
Patients with combined mixed dyslipidaemia have high blood levels of ‘ bad’ LDL cholesterol and triglycerides (a type of fat), and low levels of ‘ good’ HDL cholesterol.
Bolniki s kombinirano mešano dislipidemijo imajo v krvi visoko raven „ slabega “ LDL holesterola in trigliceridov (vrsta maščobe) in nizko raven „ dobrega “, HDL holesterola.
The first study compared the effectiveness of Tredaptive with that of nicotinic acid alone or placebo (a dummy treatment) in reducing the levels of LDL cholesterol in a total of 1,613 patients.
V prvi študiji so primerjali učinkovitost zdravila Tredaptive s samostojno nikotinsko kislino ali placebom (zdravilom brez zdravilne učinkovine) pri zniževanju ravni LDL- holesterola pri vsega skupaj 1613 bolnikih.
Tredaptive was effective in reducing the blood levels of LDL cholesterol.
Zdravilo Tredaptive je bilo učinkovito pri zniževanju ravni LDL- holesterola.
In the first study, LDL cholesterol levels were reduced by 19% in patients taking Tredaptive, compared with 1% in those taking placebo.
V prvi študiji so se ravni LDL pri bolnikih, ki so jemali zdravilo Tredaptive, znižale za 19% v primerjavi z 1% pri tistih, ki so jemali placebo.
The second study showed that the LDL cholesterol levels were further reduced when Tredaptive was taken with simvastatin (48% reduction), compared with Tredaptive alone (17% reduction) or simvastatin alone (37% reduction).
V drugi študiji so dokazali, da je prišlo še do večjega znižanja ravni LDL- holesterola v skupini, ki je jemala zdravilo Tredaptive skupaj s simvastatinom (48% znižanje), v primerjavi s tisto, ki je jemala zdravilo Tredaptive samostojno (17% znižanje) ali samo simvastatin (37% znižanje).
For the full list of all side effects reported with Tredaptive, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Tredaptive, glejte navodilo za uporabo.
The Committee for Medicinal Products for Human Use (CHMP) decided that Tredaptive’ s benefits are greater than its risks for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia and in patients with primary hypercholesterolaemia.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Tredaptive pri zdravljenju dislipidemije, zlasti pri bolnikih s kombinirano mešano dislipidemijo in pri bolnikih s primarno hiperholesterolemijo, večje od z njim povezanih tveganj.
The full EPAR for Tredaptive can be found here.
2/ 3 Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Tredaptive je na voljo tukaj.
Tredaptive 1000 mg/ 20 mg modified-release tablets.
Tredaptive 1000 mg/ 20 mg tablete s prirejenim sproščanjem
Each modified-release tablet contains 1000 mg of nicotinic acid and 20 mg of laropiprant.
Vsaka tableta s prirejenim sproščanjem vsebuje 1000 mg nikotinske kisline in 20 mg laropipranta.
Excipient Each modified-release tablet contains 128.4 mg of lactose monohydrate.
Pomožna snov Ena tableta vsebuje 128, 4 mg laktoze monohidrata.
Capsule-shaped, white to off-white tablet, with “ 552” debossed on one side.
Tablete v obliki kapsul in bele do kremaste barve z vtisnjeno oznako "552" na eni strani.
Tredaptive is indicated for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL-cholesterol and triglycerides and low HDL-cholesterol) and in patients with primary hypercholesterolaemia (heterozygous familial and non-familial).
Tredaptive je indiciran za zdravljenje dislipidemije, zlasti pri bolnikih s kombinirano mešano dislipidemijo (za katero so značilni zvišani LDL holesterol in trigliceridi in nizek HDL holesterol), in pri bolnikih s primarno hiperholesterolemijo (heterozigotno družinsko in nedružinsko).
Tredaptive should be used in patients in combination with HMG-CoA reductase inhibitors (statins), when the cholesterol lowering effect of HMG-CoA reductase inhibitor monotherapy is inadequate.
Tredaptive je treba uporabiti v kombinaciji z zaviralci reduktaze HMG- CoA (statini), če monoterapija z zaviralcem reduktaze HMG- CoA holesterola ne zniža v zadostni meri.
Diet and other non-pharmacological treatments (e. g. exercise, weight reduction) should be continued during therapy with Tredaptive.
Med zdravljenjem z zdravilom Tredaptive mora bolnik še naprej upoštevati dieto in druge nefarmakološke ukrepe zdravljenja (npr. telesno dejavnost, zmanjšanje telesne mase).
If Tredaptive is missed for less than 7 consecutive days, patients can resume therapy at the last administered dose.
Če bolnik zdravilo Tredaptive ne vzame manj kot 7 dni zapored, ga lahko znova začne jemati v nazadnje uporabljanem odmerku.
If Tredaptive is missed for 7 or more consecutive days, therapy should be resumed at the 1000 mg/ 20 mg dose for 1 week, before advancing to the maintenance dose of 2000 mg/ 40 mg.
Šele potem sme nadaljevati z vzdrževalnim odmerkom 2000 mg/ 40 mg.
2 Those patients switching from 2000 mg or more of prolonged-release nicotinic acid can initiate Tredaptive at the 2000 mg/ 40 mg dose.
Če bolnik preide na zdravilo Tredaptive s pripravka nikotinske kisline s podaljšanim sproščanjem, ki ga je jemal v odmerku 2000 mg ali več, lahko zdravilo Tredaptive začne jemati v odmerku 2000 mg/ 40 mg.
Patients switching from less than 2000 mg of prolonged-release nicotinic acid should initiate therapy at the starting dose of 1000 mg/ 20 mg and advance to the 2000 mg/ 40 mg maintenance dose after four weeks.
Če pa je jemal manj kot 2000 mg nikotinske kisline s podaljšanim sproščanjem, mora zdravljenje z zdravilom Tredaptive začeti z odmerkom 1000 mg/ 20 mg in po 4 tednih preiti na vzdrževalni odmerek 2000 mg/ 40 mg.
For patients switching from immediate-release nicotinic acid to Tredaptive, therapy should be initiated at the 1000 mg/ 20 mg dose and advanced to the 2000 mg/ 40 mg maintenance dose after four weeks.
Po štirih tednih ta odmerek povečajte na vzdrževalni odmerek 2000 mg/ 40 mg.
Method of administration The tablets should be taken whole, with food, in the evening or at bedtime.
2 Način uporabe Tablete Tredaptive mora bolnik vzeti cele, s hrano, zvečer ali pred spanjem.
Use in paediatric patients Safety and effectiveness of Tredaptive in paediatric patients have not been established.
Uporaba pri pediatričnih bolnikih Varnost in učinkovitost zdravila Tredaptive pri pediatričnih bolnikih nista ugotovljeni.
Use in patients with hepatic or renal insufficiency Use of Tredaptive in patients with hepatic or renal insufficiency has not been studied.
Uporaba pri bolnikih z insuficienco jeter ali ledvic Uporaba zdravila Tredaptive pri bolnikih z insuficienco jeter ali ledvic ni raziskana.
Like other nicotinic acid medicinal products, Tredaptive is contraindicated in patients with significant or unexplained hepatic dysfunction.
Tako kot druga zdravila z nikotinsko kislino je tudi Tredaptive kontraindiciran pri bolnikih s pomembno ali nepojasnjeno motnjo delovanja jeter.
Concomitant therapy Acetylsalicylic acid provides no additional reduction of flushing beyond that achieved by Tredaptive.
Sočasna zdravila Acetilsalicilna kislina zardevanja ne zmanjša nič bolj, kot ga že Tredaptive.
Because co-administration of bile acid sequestrants may reduce the bioavailability of acidic medicinal products such as nicotinic acid, it is recommended that Tredaptive be administered > 1 hour before or > 4 hours after administration of a bile acid sequestrant (see section 4.5).
Zato je zdravilo Tredaptive priporočljivo uporabiti več kot 1 uro pred adsorbenti žolčnih kislin ali več kot 4 ure po njih (glejte poglavje 4. 5).
When Tredaptive is co-administered with a statin, please refer to the Summary of Product Characteristics for that particular medicinal product.
Če zdravilo Tredaptive uporabite s statinom, morate upoštevati Povzetek glavnih značilnosti za to zdravilo.
Hepatic effects Switching from immediate-release (crystalline) nicotinic acid to Tredaptive has not been studied.
Učinki na jetra Prehod z nikotinske kisline s takojšnjim sproščanjem (kristalne nikotinske kisline) na zdravilo Tredaptive ni raziskan.
Therefore, patients switching from immediate-release nicotinic acid to Tredaptive should be initiated at the 1000 mg/ 20 mg dose.
Zato morate pri bolnikih, ki na zdravilo Tredaptive preidejo z nikotinske kisline s takojšnjim sproščanjem, na začetku uporabiti odmerek 1000 mg/ 20 mg.
Tredaptive should be used with caution in patients who consume substantial quantities of alcohol and/ or have a past history of liver disease.
Zdravilo Tredaptive morate previdno uporabljati pri bolnikih, ki pijejo veliko alkohola in/ ali imajo bolezni jeter v anamnezi.
Liver function tests are recommended before initiation, every 6 to 12 weeks for the first year, and periodically (e. g. semi-annually) thereafter.
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 vrednosti alanin aminotransferaze (ALT) ali aspartat
Should an increase in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of ≥ 3 X ULN persist, reduction of dose or withdrawal of Tredaptive is recommended.
3 aminotransferaze (AST), večje ali enake 3- kratni ZMN (zgornja meja normalne vrednosti), trajajo, je priporočljivo zmanjšati odmerek zdravila Tredaptive ali pa zdravilo Tredaptive prenehati uporabljati.
Physicians contemplating combined therapy with statins and Tredaptive 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.
Renal dysfunction Because nicotinic acid and its metabolites are excreted through the kidneys, Tredaptive 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 Tredaptive uporabljati previdno.
4 Acute coronary syndrome As with other nicotinic acid medicinal products, caution should be used when Tredaptive 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 Tredaptive 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, Tredaptive (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 Tredaptive (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, Tredaptive (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 Tredaptive (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.
Hipofosfatemija Tako kot druga zdravila z nikotinsko kislino je bilo tudi zdravilo Tredaptive 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).
4 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 Tredaptive contains lactose.
Pomožna snov Tredaptive 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 Tredaptive.
Ko zaužijete zdravilo Tredaptiv, sočasno ne pitje alkohola ali vročih pijač, ker to lahko poslabša zardevanje.
The pharmacokinetic interaction of Tredaptive with statins has been studied only with simvastatin (see section 4.4).
Izmed statinov, so farmakokinetične interakcije zdravila Tredaptive raziskali samo s simvastatinom (glejte poglavje 4. 4).
Because co-administration of bile acid sequestrants may reduce the bioavailability of acidic medicinal products such as nicotinic acid, it is recommended that Tredaptive be administered > 1 hour before or > 4 hours after administration of a bile acid sequestrant.
Zato je zdravilo Tredaptive priporočljivo uporabiti več kot 1 uro pred adsorbenti žolčnih kislin ali več kot 4 ure po njih.
Vitamins or other nutritional supplements containing (≥ 50 mg/ day) of nicotinic acid (or nicotinamide) have not been studied with Tredaptive.
Uporaba vitaminov in drugih prehranskih dopolnil, ki vsebujejo (≥ 50 mg/ dan) nikotinsko kislino (ali nikotinamid) hkrati z zdravilom Tredaptive ni raziskana.
Laropiprant Effects of laropiprant on other medicinal products Midazolam:
Vplivi laropipranta na druga zdravila Midazolam:
Caution should be used when Tredaptive is co-administered with medicinal products metabolised predominantly by UGT2B4 or UGT2B7, for instance zidovudine.
Previdnost je potrebna, če zdravilo Tredaptive 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).
5 izoencimov 3A4, 2C9 in 2C8 CYP ali človeškega glikoproteina P (P- gp).
Pregnancy Tredaptive There are no data from the combined use of nicotinic acid and laropiprant in pregnant women.
Tredaptive O kombinirani uporabi nikotinske kisline in laropipranta pri nosečnicah ni podatkov.
Therefore, Tredaptive should not be used during pregnancy unless clearly necessary.
Zato zdravila Tredaptive ne smete uporabljati med nosečnostjo, razen če je to nujno.
Lactation Tredaptive No studies in lactating animals have been conducted with Tredaptive.
Tredaptive Pri doječih živalih študije z zdravilom Tredaptive 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 Tredaptive 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 Tredaptive za žensko.
Animal studies have shown excretion of laropiprant in milk.
Laropiprant Študije na živalih so pokazale, da se laropiprant izloča v mleko, vendar ni znano, ali se laropiprant izloča v materino mleko pri človeku..
4.8 Undesirable effects In clinical trials, over 2500 patients received Tredaptive alone or with an HMG-CoA reductase inhibitor.
V kliničnih preskušanjih je zdravilo Tredaptive sam ali skupaj z zaviralcem reduktaze HMG- CoA dobivalo več kot 2500 bolnikov.
Flushing Flushing is the most common adverse reaction of Tredaptive.
6 Zardevanje Zardevanje je najpogostejši neželeni učinek zdravila Tredaptive.
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 Tredaptive.
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 Tredaptive.
In these studies, the percentage of patients taking Tredaptive, 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 Tredaptive 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 Tredaptive were infrequent (< 1%).
Prekinitev uporabe zaradi drugih specifičnih neželenih učinkov je bila med uporabniki zdravila Tredaptive redka (< 1%).
7 Overall adverse reactions with Tredaptive In addition to flushing, clinical adverse reactions reported by the investigators as possibly, probably, or definitely related to Tredaptive in ≥ 1% of patients treated with Tredaptive 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 Tredaptive Spodaj so našteti klinični neželeni učinki, ki so jih raziskovalci poleg zardevanja zabeležili kot možno, verjetno ali zagotovo povezane z zdravilom Tredaptive pri ≥ 1% bolnikov, zdravljenih samo z zdravilom Tredaptive (n = 945) ali hkrati s statinom (n = 1601), ter klinično pomembni neželeni učinki (< 1%) za obdobje do enega leta.
Hypersensitivity reaction (see below)
Preobčutljivostne reakcije (glejte spodaj)
Hypersensitivity reactions
Preobčutljivostne reakcije:
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 Tredaptive with or without a statin.
Med bolniki, ki so v kontroliranih kliničnih študijah uporabljali zdravilo Tredaptive (s statinom ali brez njega), je bila incidenca klinično pomembnih zvišanj serumskih transaminaz (ALT in/ ali AST ≥ 3- krat ZMN, zaporedno) 1, 0%.
Clinically important elevations of CK (≥ 10 X ULN) were seen in 0.3% of the patients treated with Tredaptive 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 Tredaptive s statinom ali brez njega (glejte poglavje 4. 4).