natgillin/translations-raw huggingface dataset:
Pregnancy and breast-feeding Talk with your doctor before taking Tredaptive if: • You are pregnant or plan to become pregnant.
Nosečnost in dojenje Preden vzamete zdravilo Tredaptive, se posvetujte z zdravnikom: • če ste noseči ali nameravate zanositi.
It is not known if Tredaptive will harm your unborn baby. • You are breast-feeding or plan to breast-feed.
Ni znano, ali Tredaptive škoduje nerojenemu otroku. • če dojite ali nameravate dojiti.
It is not known if Tredaptive will pass into your breast milk.
Ni znano, ali Tredaptive prehaja v materino mleko.
However, nicotinic acid a component of Tredaptive does pass into breast milk.
Znano pa je, da v mleko prehaja nikotinska kislina, sestavina zdravila Tredaptive.
34 Driving and using machines The effects of Tredaptive on the ability to drive and use machines have not been studied.
Vpliv na sposobnost upravljanja vozil in strojev Vplivov zdravila Tredaptive na sposobnost upravljanja vozil in strojev niso preučevali.
However, some people get dizzy after taking Tredaptive.
A nekateri ljudje po zaužitju zdravila Tredaptive postanejo omotični.
If you get dizzy, you should avoid driving or operating machines after taking Tredaptive.
Če kdaj postanete omotični, se med jemanjem zdravila Tredaptive izogibajte vožnji ali upravljanju strojev.
Important information about some of the ingredients of Tredaptive Tredaptive contains a sugar called lactose.
Pomembne informacije o nekaterih sestavinah zdravila Tredaptive Tredaptive vsebuje sladkor, imenovan laktoza.
HOW TO TAKE TREDAPTIVE
KAKO JEMATI ZDRAVILO TREDAPTIVE
Always take Tredaptive exactly as your doctor has told you.
Pri jemanju zdravila Tredaptive natančno upoštevajte zdravnikova navodila.
How to take • Take Tredaptive once a day, in the evening or at bedtime. • Take Tredaptive with food. • Swallow each tablet whole.
31 • Zdravilo Tredaptive vzemite enkrat na dan, zvečer ali pred spanjem. • Vzemite ga s hrano. • Tablete morate pogoltniti cele.
In order for your medicine to work as intended, do not split, break, crush, or chew the tablet before you swallow it. • Avoid drinking alcohol or hot drinks near the time you take your dose of Tredaptive.
Da bo zdravilo delovalo tako kot mora, tablet ne razpolavljajte, ne lomite, ne drobite in ne grizite, preden jih pogoltnete. • Ne pijte alkohola ali vročih pijač kmalu pred zaužitjem odmerka Tredaptive ali kmalu po njem.
This will lower your chance of flushing (redness of the skin, feeling warm, itching, or tingling, particularly in your head, neck, chest and upper back). • Taking aspirin before you take Tredaptive does not reduce your flushing more than taking Tredaptive alone.
Tako bo manjša možnost, da se pojavi zardevanje (pordelost kože, občutek toplote, srbenje ali mravljinčenje, še zlasti v predelu glave, vratu, prsi in zgornjega dela hrbta). • Jemanje acetilsalicilne kisline pred zaužitjem zdravila Tredaptive ne bo bolj zmanjšalo zardevanja, kot če vzamete samo zdravilo Tredaptive.
If you take more Tredaptive than you should • In the event of an overdose, the following adverse events were reported: flushing, headache, pruritus (itching), nausea, dizziness, vomiting, diarrhoea, abdominal pain/ discomfort, and back pain. • If you take more than you should, talk to a doctor or pharmacist straight away.
Če ste vzeli večji odmerek zdravila Tredaptive, kot bi smeli • V primeru prevelikega odmerjanja so poročali o naslednjih neželenih učinkih: zardevanje, glavobol, srbenje, siljenje na bruhanje, omotica, bruhanje, driska, bolečine/ nelagodje v trebuhu, bolečine v hrbtu. • Če vzamete več zdravila, kot bi smeli, se morate takoj posvetovati z zdravnikom ali s farmacevtom.
If you forget to take Tredaptive • If you miss a dose, do not take an extra dose.
Če ste pozabili vzeti zdravilo Tredaptive • Če ste pozabili vzeti odmerek, ne vzemite dodatnega.
However, if you do not take Tredaptive for 7 or more days in a row, talk to your doctor before restarting Tredaptive.
Če pa se zgodi, da zdravila Tredaptive niste vzeli 7 ali več dni zapored, se morate pred ponovnim začetkom jemanja posvetovati z zdravnikom.
If you stop taking Tredaptive Do not stop taking Tredaptive without talking to your doctor.
Če ste prenehali jemati zdravilo Tredaptive Ne nehajte jemati zdravila Tredaptive, ne da bi se posvetovali s svojim zdravnikom.
Like all medicines, Tredaptive can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Tredaptive neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Common (affects less than 1 in 10 patients) • diarrhoea • nausea (feeling sick) • dizziness • rash • pruritus (itching) • hives • upset stomach or heartburn • getting sick (vomiting) • headache • tingling or numbness of the hands or feet
Pogosti (pojavijo se pri manj kot 1 od 10 bolnikov) • driska • siljenje na bruhanje (slabost v želodcu) • omotica • izpuščaj • srbenje • koprivnica • razdražen želodec ali zgaga • slabost (bruhanje) • glavobol • mravljinčenje ali omrtvelost v dlaneh ali stopalih Občasni (pojavijo se pri manj kot 1 od 100 bolnikov)
Uncommon (affects less than 1 in 100 patients) In addition, one or more of the following symptoms have been reported as part of an allergic reaction to Tredaptive. • swelling of the face, lips, tongue, and/ or throat that may cause difficulty in breathing or swallowing (angioedema, which may require treatment right away) • fainting • shortness of breath • loss of control over urine and stool • cold sweats • shivering • chills • increased blood pressure • swelling of the lips • burning sensation • whole body rash • joint pain • swelling of the legs • rapid heart rate.
32 Kot del alergijske reakcije na zdravilo Tredaptive so poročali še o enem ali večih od naslednjih simptomov: • oteklost obraza, ustnic, jezika in/ ali žrela, ki lahko povzroči težave z dihanjem in požiranjem (angioedem, ki lahko zahteva takojšnje zdravljenje) • omedlevica • težko dihanje • izguba nadzora nad zadrževanjem urina in blata • hladno znojenje • drgetanje • mrzlica • zvišan krvni tlak • otekanje ustnic • pekoč občutek • izpuščaj po celem telesu • bolečine v sklepih • otekanje nog • hitro bitje srca.
HOW TO STORE TREDAPTIVE
SHRANJEVANJE ZDRAVILA TREDAPTIVE
Do not use Tredaptive after the expiry date (EXP) which is stated on the carton and the blister.
Zdravila Tredaptive ne smete uporabljati po datumu izteka roka uporabnosti (Uporabno do:), ki je naveden na škatli in pretisnem omotu.
What Tredaptive contains • The active substances are nicotinic acid and laropiprant.
Kaj vsebuje zdravilo Tredaptive • Zdravilni učinkovini sta nikotinska kislina in laropiprant.
What Tredaptive looks like and contents of the pack Each modified-release tablet is a capsule-shaped, white to off-white tablet, with “ 552” debossed on one side.
Izgled zdravila Tredaptive in vsebina pakiranja Tablete s prirejenim sproščanjem so v obliki kapsul, bele do kremaste barve in imajo na eni strani vtisnjeno oznako "552".
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 196 (2
Aluminium/ Aluminium blister with push-through lidding in pack sizes of 14, 28, 56, 168 modified-release tablets and 32 x 1 modified-release tablets in perforated unit dose blister.
Aluminijsko/ aluminijski pretisni omot s prekritjem, skozi katerega se potisne tableta, v pakiranjih s 14, 28, 56, 168 tabletami s prirejenim sproščanjem ter 32 x 1 tableto s prirejenim sproščanjem v perforiranem pretisnem omotu za enkratni odmerek.
Trevaclyn 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 Trevaclyn 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.
The first study compared the effectiveness of Trevaclyn 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 Trevaclyn s samostojno nikotinsko kislino ali placebom (zdravilom brez zdravilne učinkovine) pri zniževanju ravni LDL- holesterola pri vsega skupaj 1613 bolnikih.
Trevaclyn was effective in reducing the blood levels of LDL cholesterol.
Zdravilo Trevaclyn je bilo učinkovito pri zniževanju ravni LDL- holesterola.
In the first study, LDL cholesterol levels were reduced by 19% in patients taking Trevaclyn, compared with 1% in those taking placebo.
V prvi študiji so se ravni LDL pri bolnikih, ki so jemali zdravilo Trevaclyn, 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 Trevaclyn was taken with simvastatin (48% reduction), compared with Trevaclyn 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 Trevaclyn skupaj s simvastatinom (48% znižanje), v primerjavi s tisto, ki je jemala zdravilo Trevaclyn samostojno (17% znižanje) ali samo simvastatin (37% znižanje).
The Committee for Medicinal Products for Human Use (CHMP) decided that Trevaclyn’ 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 Trevaclyn pri zdravljenju dislipidemije, zlasti pri bolnikih s kombinirano mešano dislipidemijo in bolnikih s primarno hiperholesterolemijo, večje od z njim povezanih tveganj.
The full EPAR for Trevaclyn can be found here.
2/ 3 Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Trevaclyn je na voljo tukaj.
Trevaclyn 1000 mg/ 20 mg modified-release tablets.
Trevaclyn 1000 mg/ 20 mg tablete s prirejenim sproščanjem
Trevaclyn 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).
Trevaclyn 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).
Trevaclyn 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.
Trevaclyn 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 Trevaclyn.
Med zdravljenjem z zdravilom Trevaclyn mora bolnik še naprej upoštevati dieto in druge nefarmakološke ukrepe zdravljenja (npr. telesno dejavnost, zmanjšanje telesne mase).
If Trevaclyn is missed for less than 7 consecutive days, patients can resume therapy at the last administered dose.
Če bolnik zdravilo Trevaclyn ne vzame manj kot 7 dni zapored, ga lahko znova začne jemati v nazadnje uporabljanem odmerku.
If Trevaclyn 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 Trevaclyn at the 2000 mg/ 40 mg dose.
Če bolnik preide na zdravilo Trevaclyn s pripravka nikotinske kisline s podaljšanim sproščanjem, ki ga je jemal v odmerku 2000 mg ali več, lahko zdravilo Trevaclyn 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 Trevaclyn 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 Trevaclyn, 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 Trevaclyn mora bolnik vzeti cele, s hrano, zvečer ali pred spanjem.
Use in paediatric patients Safety and effectiveness of Trevaclyn in paediatric patients have not been established.
Uporaba pri pediatričnih bolnikih Varnost in učinkovitost zdravila Trevaclyn pri pediatričnih bolnikih nista ugotovljeni.
Use in patients with hepatic or renal insufficiency Use of Trevaclyn in patients with hepatic or renal insufficiency has not been studied.
Uporaba pri bolnikih z insuficienco jeter ali ledvic Uporaba zdravila Trevaclyn pri bolnikih z insuficienco jeter ali ledvic ni raziskana.
Like other nicotinic acid medicinal products, Trevaclyn is contraindicated in patients with significant or unexplained hepatic dysfunction.
Tako kot druga zdravila z nikotinsko kislino je tudi Trevaclyn kontraindiciran pri bolnikih s pomembno ali nepojasnjeno motnjo delovanja jeter.
Concomitant therapy Acetylsalicylic acid provides no additional reduction of flushing beyond that achieved by Trevaclyn.
Sočasna zdravila Acetilsalicilna kislina zardevanja ne zmanjša nič bolj, kot ga že Trevaclyn.
Because co-administration of bile acid sequestrants may reduce the bioavailability of acidic medicinal products such as nicotinic acid, it is recommended that Trevaclyn be administered > 1 hour before or > 4 hours after administration of a bile acid sequestrant (see section 4.5).
Zato je zdravilo Trevaclyn priporočljivo uporabiti več kot 1 uro pred adsorbenti žolčnih kislin ali več kot 4 ure po njih (glejte poglavje 4. 5).
When Trevaclyn is co-administered with a statin, please refer to the Summary of Product Characteristics for that particular medicinal product.
Če zdravilo Trevaclyn uporabite s statinom, morate upoštevati Povzetek glavnih značilnosti za to zdravilo.
Hepatic effects Switching from immediate-release (crystalline) nicotinic acid to Trevaclyn has not been studied.
Učinki na jetra Prehod z nikotinske kisline s takojšnjim sproščanjem (kristalne nikotinske kisline) na zdravilo Trevaclyn ni raziskan.
Therefore, patients switching from immediate-release nicotinic acid to Trevaclyn should be initiated at the 1000 mg/ 20 mg dose.
Zato morate pri bolnikih, ki na zdravilo Trevaclyn preidejo z nikotinske kisline s takojšnjim sproščanjem, na začetku uporabiti odmerek 1000 mg/ 20 mg.
Trevaclyn should be used with caution in patients who consume substantial quantities of alcohol and/ or have a past history of liver disease.
Zdravilo Trevaclyn morate previdno uporabljati pri bolnikih, ki pijejo veliko alkohola in/ ali imajo bolezni jeter v anamnezi.
Should an increase in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of ≥ 3 X ULN persist, reduction of dose or withdrawal of Trevaclyn is recommended.
Če vrednosti alanin aminotransferaze (ALT) ali aspartat aminotransferaze (AST), večje ali enake 3- kratni ZMN (zgornja meja normalne vrednosti), trajajo, je priporočljivo zmanjšati odmerek zdravila Trevaclyn ali pa zdravilo Trevaclyn prenehati uporabljati.
Physicians contemplating combined therapy with statins and Trevaclyn 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, Trevaclyn 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 Trevaclyn uporabljati previdno.
4 Acute coronary syndrome As with other nicotinic acid medicinal products, caution should be used when Trevaclyn 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 Trevaclyn 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, Trevaclyn (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 Trevaclyn (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, Trevaclyn (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 Trevaclyn (2000 mg/ 40 mg) povezano z majhnim zvišanjem sečne kisline (glejte poglavje 4. 8).
Therefore, patients with a risk for hypophosphatemia should be closely followed.
4 Hipofosfatemija Tako kot druga zdravila z nikotinsko kislino je bilo tudi zdravilo Trevaclyn povezano z manjšim zmanjšanjem koncentracije fosforja, zato morate bolnike s tveganjem za hipofosfatemijo skrbno spremljati.
Excipient Trevaclyn contains lactose.
Pomožna snov Trevaclyn 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 Trevaclyn.
Ko zaužijete zdravilo Tredaptiv, sočasno ne pitje alkohola ali vročih pijač, ker to lahko poslabša zardevanje.
The pharmacokinetic interaction of Trevaclyn with statins has been studied only with simvastatin (see section 4.4).
Izmed statinov, so farmakokinetične interakcije zdravila Trevaclyn 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 Trevaclyn be administered > 1 hour before or > 4 hours after administration of a bile acid sequestrant.
Zato je zdravilo Trevaclyn 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 Trevaclyn.
Uporaba vitaminov in drugih prehranskih dopolnil, ki vsebujejo (≥ 50 mg/ dan) nikotinsko kislino (ali nikotinamid) hkrati z zdravilom Trevaclyn ni raziskana.
Caution should be used when Trevaclyn is co-administered with medicinal products metabolised predominantly by UGT2B4 or UGT2B7, for instance zidovudine.
Previdnost je potrebna, če zdravilo Trevaclyn uporabljate hkrati z zdravili, ki se presnavljajo predvsem z UGT2B4 ali UGT2B7, na primer z zidovudinom.
Pregnancy Trevaclyn There are no data from the combined use of nicotinic acid and laropiprant in pregnant women.
Trevaclyn O kombinirani uporabi nikotinske kisline in laropipranta pri nosečnicah ni podatkov.
Therefore, Trevaclyn should not be used during pregnancy unless clearly necessary.
Zato zdravila Trevaclyn ne smete uporabljati med nosečnostjo, razen če je to nujno.
Lactation Trevaclyn No studies in lactating animals have been conducted with Trevaclyn.
Trevaclyn Pri doječih živalih študije z zdravilom Trevaclyn 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 Trevaclyn 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 Trevaclyn za žensko.
4.8 Undesirable effects In clinical trials, over 2500 patients received Trevaclyn alone or with an HMG-CoA reductase inhibitor.
V kliničnih preskušanjih je zdravilo Trevaclyn sam ali skupaj z zaviralcem reduktaze HMG- CoA dobivalo več kot 2500 bolnikov.
Flushing Flushing is the most common adverse reaction of Trevaclyn.
Zardevanje Zardevanje je najpogostejši neželeni učinek zdravila Trevaclyn.
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 Trevaclyn.
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 Trevaclyn.
In these studies, the percentage of patients taking Trevaclyn, 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 Trevaclyn 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 Trevaclyn were infrequent (< 1%).
Prekinitev uporabe zaradi drugih specifičnih neželenih učinkov je bila med uporabniki zdravila Trevaclyn redka (< 1%).
7 Overall adverse reactions with Trevaclyn In addition to flushing, clinical adverse reactions reported by the investigators as possibly, probably, or definitely related to Trevaclyn in ≥ 1% of patients treated with Trevaclyn 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 Trevaclyn Spodaj so našteti klinični neželeni učinki, ki so jih raziskovalci poleg zardevanja zabeležili kot možno, verjetno ali zagotovo povezane z zdravilom Trevaclyn pri ≥ 1% bolnikov, zdravljenih samo z zdravilom Trevaclyn (n = 945) ali hkrati s statinom (n = 1601), ter klinično pomembni neželeni učinki (< 1%) za obdobje do enega leta.
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 Trevaclyn with or without a statin.
Med bolniki, ki so v kontroliranih kliničnih študijah uporabljali zdravilo Trevaclyn (s statinom ali brez njega), je bila incidenca klinično pomembnih zvišanj serumskih transaminaz (ALT in/ ali AST ≥ 3- krat ZMN, zaporedno) 1, 0%.