natgillin/translations-raw huggingface dataset:
Brilique affects cells called ‘platelets' (also called thrombocytes).
Zdravilo Brilique vpliva na celice, ki jih imenujemo trombociti (ali krvne ploščice).
The pharmacokinetics of ticagrelor and AR-C124910XX in patients with a history of MI were generally similar to that in the ACS population.
Farmakokinetika ticagrelorja in AR-C124910XX je bila pri bolnikih z anamnezo miokardnega infarkta na splošno podobna kot v populaciji z AKS.
There were few fatal bleeding events in the study, 11 (0.3%) for ticagrelor 60 mg and 12 (0.3%) for ASA therapy alone.
V študiji je bilo malo krvavitev s smrtnim izidom, 11 (0,3 %) med uporabo 60 mg ticagrelorja in 12 (0,3 %) med uporabo same ASA.
Platelet transfusion is unlikely to be of clinical benefit in patients with bleeding (see section 4.4).
Ni verjetno, da bi transfuzija trombocitov klinično koristila bolnikom s krvavitvijo (glejte poglavje 4.4).
The formation of the major circulating metabolite AR-C124910XX (also active) from ticagrelor is rapid with a median tmax of approximately 2.5 hours.
Glavni presnovek v obtoku, AR-C124910XX, (ki je tudi aktiven) nastane iz ticagrelorja hitro; mediani tmax je približno 2,5 ure.
In PLATO, the frequency of gouty arthritis was 0.2% for ticagrelor vs. 0.1% for clopidogrel.
V študiji PLATO je bila pogostnost protinskega artritisa 0,2 % s ticagrelorjem in 0,1 % s klopidogrelom.
Ticagrelor as well as the active metabolite are P-gp substrates.
Ticagrelor in aktivni presnovek sta oba substrata P-gp.
MI (excl. silent MI) Stroke
MI (izključujoč nemi MI)
Patients can be switched from clopidogrel to ticagrelor without any interruption of antiplatelet effect (see section 4.2).
Bolniki lahko preidejo s klopidogrela na ticagrelor brez prekinitve antiagregacijskega učinka (glejte poglavje 4.2).
PLATO included patients with baseline congestive heart failure, COPD or asthma; these patients, and the elderly, were more likely to report dyspnoea.
Študija PLATO je zajela bolnike, ki so izhodiščno imeli srčno popuščanje, KOPB ali astmo; pri teh in pa pri starejših bolnikih je bila verjetnost dispneje večja.
Uric acid elevations: In PLATO, serum uric acid increased to more than upper limit of normal in 22% of patients receiving ticagrelor compared to 13% of patients receiving clopidogrel.
Zvišanje sečne kisline: V študiji PLATO se je koncentracija sečne kisline v serumu povečala nad zgornjo normalno mejo pri 22 % bolnikov, ki so dobivali ticagrelor, in pri 13 % tistih, ki so dobivali klopidogrel.
The AUC of the active metabolite was increased by 32% and Cmax was decreased by 15% in the presence of cyclosporine.
V prisotnosti ciklosporina se je AUC aktivnega presnovka povečala za 32 %, njegova Cmax pa se je zmanjšala za 15 %.
If clinically indicated, medicinal products that alter haemostasis should be used with caution in combination with ticagrelor.
Če so klinično indicirana zdravila, ki vplivajo na hemostazo, jih je treba v kombinaciji s ticagrelorjem uporabljati previdno.
Patients were eligible to participate if they were aged 50 years or over, with a history of MI (1 to 3 years prior to randomisation), and had at least one of the following risk factors for atherothrombosis: age ≥65 years, diabetes mellitus requiring medication, a second prior MI, evidence of multivessel CAD or chronic non-end-stage renal dysfunction.
Za sodelovanje so bili primerni bolniki, stari 50 let ali več, z anamnezo miokardnega infarkta (od 1 do 3 leta pred randomizacijo) in vsaj enim od naslednjih dejavnikov tveganja za aterotrombozo: starost ≥ 65 let, sladkorna bolezen, ki zahteva zdravila, drugi predhodni miokardni infarkt, znaki večžilne bolezni koronarnih arterij ali kronično moteno delovanje ledvic, ki ni v končni fazi.
Since co-administration of ticagrelor with desmopressin did not decrease template-bleeding time, desmopressin is unlikely to be effective in managing clinical bleeding events (see section 4.5).
Sočasna uporaba ticagrelorja z dezmopresinom ni skrajšala standardiziranega časa krvavitve ("template bleeding time"), zato ni verjetno, da bi bil dezmopresin učinkovit za obvladovanje kliničnih krvavitev (glejte poglavje 4.5).
clarithromycin, nefazodone, ritonavir and atazanavir), as co-administration may lead to a substantial increase in exposure to ticagrelor (see section 4.5).
klaritromicinom, nefazadonom, ritonavirjem ali atazanavirjem), ker lahko bistveno poveča izpostavljenost ticagrelorju (glejte poglavje 4.5).
In PEGASUS, TIMI Major bleeding for ticagrelor 60 mg twice daily was higher than for ASA alone.
V študiji PEGASUS je bilo hudih krvavitev po TIMI s 60 mg ticagrelorja dvakrat na dan več kot s samo ASA.
Due to observations of mostly asymptomatic ventricular pauses and bradycardia, caution should be exercised when administering ticagrelor concomitantly with medicinal products known to induce bradycardia (see section 4.4).
Zdravila, za katera je znano, da povzročajo bradikardijo Zaradi pojavljanja ventrikularnih pavz in bradikardije, ki so večinoma asimptomatske, je previdnost potrebna pri uporabi ticagrelorja sočasno z zdravili, za katera je znano, da povzročajo bradikardijo (glejte poglavje 4.4).
Brilique, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with - acute coronary syndromes (ACS) or - a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event (see sections 4.2 and 5.1).
Zdravilo Brilique je sočasno z acetilsalicilno kislino (ASA) indicirano za preprečevanje aterotrombotičnih dogodkov pri odraslih bolnikih z - akutnimi koronarnimi sindromi (AKS) ali - anamnezo miokardnega infarkta in velikim tveganjem za pojav aterotrombotičnega dogodka (glejte poglavji 4.2 in 5.1).
• Co-administration of ticagrelor with strong CYP3A4 inhibitors (e.g. ketoconazole,
• Sočasna uporaba ticagrelorja z močnimi zaviralci CYP3A4 (npr. s ketokonazolom,
There are no or limited amount of data from the use of ticagrelor in pregnant women.
O uporabi ticagrelorja pri nosečnicah podatkov ni ali jih je malo.
If you stop taking Brilique, it may increase your chances of having another heart attack or stroke or dying from a disease related to your heart or blood vessels.
Če prenehate jemati zdravilo Brilique, se vam lahko poveča možnost ponovnega srčnega infarkta, možganske kapi ali smrti zaradi bolezni, povezane s srcem ali ožiljem.
Only limited information is available in patients with moderate hepatic impairment.
O bolnikih z zmerno okvaro jeter je na voljo le malo podatkov.
Compared with clopidogrel, patients with asthma/COPD treated with ticagrelor may have an increased risk of experiencing non-serious dyspnoea (3.29% ticagrelor versus 0.53% clopidogrel) and serious dyspnoea (0.38% ticagrelor versus 0.00% clopidogrel).
V primerjavi s klopidogrelom imajo lahko bolniki z astmo/KOPB, ki dobivajo ticagrelor, večje tveganje ne-resne dispneje (3,29 % s ticagrelorjem v primerjavi z 0,53 % s klopidogrelom) in resne dispneje (0,38 % s ticagrelorjem v primerjavi z 0,00 % s klopidogrelom).
Holter ECG monitoring has shown an increased frequency of mostly asymptomatic ventricular pauses during treatment with ticagrelor compared with clopidogrel.
Holtersko spremljanje EKG je med uporabo ticagrelorja pokazalo večjo pogostnost večinoma asimptomatskih ventrikularnih pavz kot med uporabo klopidogrela.
• Atorvastatin - Co-administration of atorvastatin and ticagrelor increased atorvastatin acid Cmax by 23% and AUC by 36%.
• Atorvastatin - Sočasna uporaba atorvastatina in ticagrelorja je povečala Cmax atorvastatinske kisline za 23 % in njeno AUC za 36 %.
The mixture can also be administered via a nasogastric tube (CH8 or greater).
Tako pripravljeno mešanico se lahko daje tudi po nazogastrični sondi (CH8 ali več).
Due to reports of cutaneous bleeding abnormalities with SSRIs (e.g. paroxetine, sertraline and citalopram), caution is advised when administering SSRIs with ticagrelor as this may increase the risk of bleeding.
Zaradi poročil o kožnih krvavitvenih motnjah med uporabo selektivnih zaviralcev prevzema serotonina, (npr. paroksetina, sertralina in citaloprama) je pri sočasni uporabi selektivnih zaviralcev serotonina in ticagrelorja potrebna previdnost, ker lahko poveča tveganje krvavitev.
The use of ticagrelor is contraindicated in patients with active pathological bleeding, in those with a history of intracranial haemorrhage, and in patients with severe hepatic impairment (see section 4.3).
Uporaba ticagrelorja je kontraindicirana pri bolnikih z aktivno patološko krvavitvijo, bolnikih z anamnezo intrakranialne krvavitve in bolnikih s hudo okvaro jeter (glejte poglavje 4.3).
There is currently no known antidote to reverse the effects of ticagrelor, and ticagrelor is not dialysable (see section 5.2).
Trenutno ni antidota, ki bi odpravil učinke ticagrelorja in učinkovina se z dializo ne odstrani (glejte poglavje 5.2).
In rats, minor developmental anomalies were seen at a maternal toxic dose (safety margin of 5.1).
Pri podganah so pri odmerkih, toksičnih za samice opazili manjše razvojne nepravilnosti (varnostna meja 5,1).
In PLATO, dyspnoea adverse events (AEs) (dyspnoea, dyspnoea at rest, dyspnoea exertional, dyspnoea paroxysmal nocturnal and nocturnal dyspnoea), when combined, was reported by 13.8% of patients treated with ticagrelor and by 7.8% of patients treated with clopidogrel.
Skupaj so se v študiji PLATO neželeni dogodki z dispnejo (dispneja, dispneja v mirovanju, dispneja med naporom, paroksizmalna nočna dispneja in nočna dispneja) pojavili pri 13,8 % bolnikov, zdravljenih s ticagrelorjem, in pri 7,8 % bolnikov, zdravljenih s klopidogrelom.
The most commonly reported adverse reactions in patients treated with ticagrelor were bleeding and dyspnoea (see section 4.4).
Najpogosteje opisana neželena učinka pri bolnikih, zdravljenih s ticagrelorjem, sta bila krvavitev in dispneja (glejte poglavje 4.4).
Increased bleeding patterns similar to TIMI Major were seen for TIMI Major or Minor and PLATO Major and PLATO Major or Minor bleeding categories (see Table 3).
Podobne vzorce povečanja kot pri hudih po TIMI so opažali v kategorijah krvavitev hude in blage po TIMI, hude po PLATO in hude in blage po PLATO (glejte preglednico 3).
It is important to flush the nasogastric tube through with water after administration of the mixture.
Pomembno je, da se nazogastrično sondo po dajanju mešanice spere z vodo.
Following an oral ticagrelor 90 mg single dose under fasted conditions in healthy subjects, Cmax is 529 ng/ml and AUC is 3451 ng*h/ml.
Po peroralni uporabi enkratnega odmerka 90 mg ticagrelorja na tešče pri zdravih osebah je Cmax 529 ng/ml in AUC 3451 ng*h/ml.
In clinical studies, ticagrelor was commonly administered with ASA, proton pump inhibitors, statins, beta-blockers, angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers as needed for concomitant conditions for long-term and also heparin, low molecular weight heparin and intravenous GpIIb/IIIa inhibitors for short durations (see section 5.1).
V kliničnih študijah so ticagrelor pogosto uporabljali z ASA, zaviralci protonske črpalke, statini, antagonisti adrenergičnih receptorjev beta, zaviralci angiotenzinske konvertaze in zaviralci receptorjev angiotenzina, kot je bilo potrebno za dolgotrajno zdravljenje sočasnih bolezni, kratkotrajno pa tudi s heparinom, nizkomolekularnim heparinom in intravenskimi zaviralci GpIIb/IIIa (glejte poglavje 5.1).
More patients had ventricular pauses with ticagrelor (6.0%) than with clopidogrel (3.5%) in the acute phase; and 2.2% and 1.6%, respectively, after 1 month (see section 4.4).
V akutni fazi je imelo ventrikularne pavze več bolnikov, ki so prejemali ticagrelor (6,0 %), kot tistih, ki so prejemali klopidogrel (3,5 %); po 1 mesecu sta bila ta deleža 2,2 % in 1,6 % (glejte poglavje 4.4).
Cyclosporine (P-gp and CYP3A inhibitor)
Ciklosporin (zaviralec P-gp in CYP3A4)
Ticagrelor should be used with caution in patients with history of asthma and/or COPD (see section 4.4).
Ticagrelor je treba previdno uporabljati pri bolnikih z astmo in/ali KOPB (glejte poglavje 4.4).
TIMI Major or Minor or Requiring medical attention
Hude ali blage po TIMI s potrebo po medicinski oskrbi:
In PLATO patients undergoing coronary artery bypass grafting (CABG), ticagrelor had more bleeding than clopidogrel when stopped within 1 day prior to surgery but a similar rate of major bleeds compared to clopidogrel after stopping therapy 2 or more days before surgery (see section 4.8).
Bolniki z obvodno operacijo koronarnih arterij (CABG) so imeli v študiji PLATO s ticagrelorjem več krvavitev kot s klopidogrelom, če so prenehali z jemanjem ticagrelorja 1 dan pred operacijo, toda podoben delež hujših krvavitev kot med uporabo klopidogrela, če se je zdravljenje končalo 2 dni ali več pred operacijo (glejte poglavje 4.8).
Clinical pharmacology interaction studies showed that co-administration of ticagrelor with heparin, enoxaparin and ASA or desmopressin did not have any effect on the pharmacokinetics of ticagrelor or the active metabolite or on ADP-induced platelet aggregation compared with ticagrelor alone.
Klinične farmakološke študije medsebojnega delovanja so pokazale, da sočasna uporaba ticagrelorja s heparinom, enoksaparinom in ASA ali dezmopresinom ni vplivala na farmakokinetiko ticagrelorja ali aktivnega presnovka; prav tako v primerjavi s ticagrelorjem ni vplivala na agregacijo trombocitov, izzvano z ADP.
Non-CABG PLATO Major bleeding was increased with ticagrelor compared clopidogrel in patients with one or more CYP2C19 loss of function alleles, but similar to clopidogrel in patients with no loss of function allele.
Hudih, s CABG nepovezanih krvavitev po PLATO je bilo s ticagrelorjem več kot s klopidogrelom pri bolnikih, ki so imeli izgubo enega ali več funkcijskih alelov CYP2C19, a je bilo podobno kot s klopidogrelom pri bolnikih brez izgube funkcijskega alela.
This imbalance did not occur at one month: 2.0% versus 2.1% for ticagrelor patients with and without CHF history, respectively; and 3.8% versus 1.4% with clopidogrel.
Te razlike po enem mesecu ni bilo: s ticagrelorjem 2,0 % med bolniki z anamnezo kongestivnega srčnega popuščanja in 2,1 % pri bolnikih brez takšne anamneze, s klopidogrelom pa 3,8 % v primerjavi z 1,4 %.
The following adverse reactions have been identified following studies or have been reported in post-marketing experience with ticagrelor (Table 1).
Po študijah s ticagrelorjem ali na podlagi poročil iz obdobja trženja so ugotovili naslednje neželene učinke (preglednica 1).
Non-CABG related bleeding and non-procedural related bleeding:
Krvavitve, nepovezane z obvodno operacijo koronarnih arterij in nepovezane s postopki:
The primary route of ticagrelor elimination is via hepatic metabolism.
Primarna pot odstranjevanja ticagrelorja je presnova v jetrih.
Patients who reported dyspnoea tended to be older and more frequently had dyspnoea, COPD or asthma at baseline.
Bolniki, ki so navajali dispnejo, so bili praviloma starejši in so pogosteje že izhodiščno imeli dispnejo, KOPB ali astmo.
A combined efficacy and safety composite (CV death, MI, stroke, or PLATO-defined ‘Total Major' bleeding) indicates that the benefit in efficacy of ticagrelor compared to clopidogrel is not offset by the major bleeding events (ARR 1.4%, RRR 8%, HR 0.92; p=0.0257) over 12 months after ACS.
Kombiniran sestavljeni opazovani dogodek učinkovitosti in varnosti (kardiovaskularna smrt, miokardni infarkt, možganska kap ali "vse hude" krvavitve po opredelitvi PLATO) kaže, da koristi glede učinkovitosti ticagrelorja v primerjavi s klopidogrelom ne odpravijo hudi krvavitveni dogodki (ARR 1,4 %, RRR 8 %, razmerje ogroženosti 0,92, p = 0,0257) v 12 mesecih po akutnem koronarnem sindromu.
In addition, caution should be exercised when administering ticagrelor concomitantly with medicinal products known to induce bradycardia.
Poleg tega je potrebna previdnost, če je ticagrelor uporabljen skupaj z zdravili, ki povzročajo bradikardijo.
Table 1 - Adverse reactions by frequency and system organ class (SOC)
Preglednica 1 - Neželeni učinki po pogostnosti in organskih sistemih
A delayed and decreased exposure to oral P2Y12 inhibitors, including ticagrelor and its active metabolite, has been observed in patients with ACS treated with morphine (35% reduction in ticagrelor exposure).
Pri bolnikih z AKS, ki so prejemali morfin, so opažali zapoznelo in zmanjšano izpostavljenost peroralnim zaviralcem P2Y12, vključno s ticagrelorjem in njegovimi aktivnimi presnovki (35-odstotno zmanjšanje izpostavljenosti ticagrelorju).
Al/Al perforated unit dose blister of 8 or 10 tablets; cartons of 10 x 1 tablets (1 blister), cartons of 56 x 1 tablets (7 blisters) and cartons of 60 x 1 tablets (6 blisters).
Perforirani pretisni omoti iz Al/Al z 8 ali 10 tabletami; škatle z 10 x 1 tableto (1 pretisni omot), škatle s 56 x 1 tableto (7 pretisnih omotov) in škatle s 60 x 1 tableto (6 pretisnih omotov).
Effects of ticagrelor on other medicinal products
Učinki ticagrelorja na druga zdravila
Other moderate CYP3A4 inhibitors (e.g. amprenavir, aprepitant, erythromycin and fluconazole) would be expected to have a similar effect and can as well be co-administered with ticagrelor.
Pričakovati je mogoče, da drugi zmerni zaviralci CYP3A4 (npr. amprenavir, aprepitant, eritromicin in flukonazol) vplivajo podobno in se jih prav tako lahko uporablja hkrati s ticagrelorjem.
Mon Tue Wed Thu Fri Sat Sun Sun/Moon symbol
Pon Tor Sre Čet Pet Sob Ned simbol sonce/mesec
Thrombotic Thrombocytopenic Purpura (TTP) has been reported very rarely with the use of ticagrelor.
Zelo redko so med uporabo ticagrelorja poročali o trombotični trombocitopenični purpuri (TTP).
14 film-coated tablets 56 film-coated tablets 60 film-coated tablets 168 film-coated tablets 180 film-coated tablets
14 filmsko obloženih tablet 56 filmsko obloženih tablet 60 filmsko obloženih tablet 168 filmsko obloženih tablet 180 filmsko obloženih tablet
In patients with end stage renal disease on haemodialysis AUC and Cmax of ticagrelor 90 mg administered on a day without dialysis were 38% and 51% higher compared to subjects with normal renal function.
Pri bolnikih s končno odpovedjo ledvic na hemodializi je bila AUC ticagrelorja, uporabljenega v odmerku 90 mg na dan brez dialize, 38 % večja in njegova Cmax 51 % večja kot pri osebah z normalnim delovanjem ledvic.
• Non-Steroidal Anti-Inflammatory Drugs (abbreviated as NSAIDs) often taken as painkillers such as ibuprofen and naproxen.
• nesteroidna protivnetna zdravila (s kratico: NSAID), ki se pogosto uporabljajo proti bolečinam, npr. ibuprofen ali naproksen.
TIMI Major: Fatal bleeding, OR any intracranial bleeding, OR clinically overt signs of haemorrhage associated with a drop in haemoglobin (Hgb) of ≥50 g/L, or when Hgb is not available, a fall in haematocrit (Hct) of 15%.
Hude po TIMI: Krvavitev s smrtnim izidom ALI katera koli intrakranialna krvavitev ALI klinični znaki krvavitve z znižanjem hemoglobina (Hgb) za ≥ 50 g/l ali, če Hgb ni na voljo, znižanje hematokrita (Ht) za 15 %.
Thus, Brilique 90 mg twice daily together with low-dose ASA can be used in patients with ACS (unstable angina, non-ST elevation Myocardial Infarction [NSTEMI] or ST elevation Myocardial Infarction [STEMI]); including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG).
Zdravilo Brilique 90 mg dvakrat na dan je torej mogoče uporabljati skupaj z nizkoodmerno ASA pri bolnikih z AKS (nestabilno angino pektoris, miokardnim infarktom brez dviga ST [NSTEMI] ali z dvigom ST [STEMI]), vključno s konzervativno zdravljenimi bolniki in bolniki, zdravljenimi s perkutano koronarno intervencijo (PKI) ali obvodno koronarno operacijo.
However, due to potential pharmacodynamic interactions, caution should be exercised with the concomitant administration of ticagrelor with medicinal products known to alter haemostasis.
Toda zaradi možnih farmakodinamičnih medsebojnih delovanj je med sočasno uporabo ticagrelorja in zdravil, ki vplivajo na hemostazo, potrebna previdnost.
The mean trough digoxin levels were increased about 30% with ticagrelor co-administration with some individual maximum increases to 2-fold.
Sočasna uporaba ticagrelorja je povečala povprečno najmanjšo koncentracijo digoksina za približno 30 %, nekatera individualna največja povečanja pa so segala do 2-krat.
Women of childbearing potential should use appropriate contraceptive measures to avoid pregnancy during ticagrelor therapy.
Ženske v rodni dobi morajo med zdravljenjem s ticagrelorjem za preprečitev nosečnosti uporabljati ustrezno kontracepcijsko zaščito.
The treatment effect of ticagrelor over clopidogrel appears consistent across many subgroups, including weight; sex; medical history of diabetes mellitus, transient ischaemic attack or non-haemorrhagic stroke, or revascularisation; concomitant therapies including heparins, GpIIb/IIIa inhibitors and proton pump inhibitors (see section 4.5); final index event diagnosis (STEMI, NSTEMI or UA); and treatment pathway intended at randomisation (invasive or medical).
Kot kaže, je ta terapevtski učinek ticagrelorja pred klopidogrelom stalen po številnih podskupinah, vključno s telesno maso, spolom, zdravstveno anamnezo sladkorne bolezni, tranzitorno ishemično atako ali nehemoragično možgansko kapjo oz. revaskularizacijo, sočasnimi zdravili (vključno s heparini, zaviralci GpIIb/IIIa in zaviralci protonske črpalke; glejte poglavje 4.5), diagnozo končnega indeksnega dogodka (STEMI, NSTEMI ali nestabilna AP) ter terapevtske poti, nameravane pri randomizaciji (invazivna ali neinvazivna).
Ticagrelor 90 mg twice daily (% patients with event) N=9333
Ticagrelor 90 mg dvakrat na dan (% bolnikov z dogodkom) n = 9333
The increase in Holter-detected ventricular pauses with ticagrelor was higher in patients with chronic heart failure (CHF) than in the overall study population during the acute phase of ACS, but not at one month with ticagrelor or compared to clopidogrel.
Povečanje števila holtersko ugotovljenih ventrikularnih pavz je bilo med uporabo ticagrelorja v primerjavi s klopidogrelom pri bolnikih s kroničnim srčnim popuščanjem v akutni fazi AKS večje kot v celotni študijski populaciji, ne pa tudi po enem mesecu.
In PEGASUS, patients on ticagrelor had a higher incidence of discontinuation due to adverse events compared to ASA therapy alone (16.1% for ticagrelor 60 mg with ASA vs. 8.5% for ASA therapy alone).
V preskušanju PEGASUS je bila incidenca prekinitev zaradi neželenih učinkov med bolniki s ticagrelorjem večja kot med tistimi, ki so prejemali samo ASA (16,1 % s 60 mg ticagrelorja in 8,5 % s samo ASA).
The increase in ventricular pauses in the acute phase of ACS was more pronounced in ticagrelor patients with history of CHF (9.2% versus 5.4% in patients without CHF history; for clopidogrel patients, 4.0% in those with versus 3.6% in those without CHF history).
Porast ventrikularnih pavz v akutni fazi AKS je bil izrazitejši pri bolnikih, ki so dobivali ticagrelor in so imeli anamnezo kongestivnega srčnega popuščanja (9,2 % v primerjavi s 5,4 % med bolniki brez takšne anamneze; pri bolnikih, ki so dobivali klopidogrel, 4,0 % pri tistih z anamnezo kongestivnega srčnega popuščanja in 3,6 % pri tistih brez takšne anamneze.
Bleeding risk The use of ticagrelor in patients at known increased risk for bleeding should be balanced against the benefit in terms of prevention of atherothrombotic events (see sections 4.8 and 5.1).
Tveganje krvavitev Uporabo ticagrelorja je treba pri bolnikih z večjim tveganjem krvavitev pretehtati v primerjavi s koristmi preprečevanja aterotrombotičnih dogodkov (glejte poglavji 4.8 in 5.1).
Brilique treatment should be initiated with a single 180 mg loading dose (two tablets of 90 mg) and then continued at 90 mg twice daily.Treatment with Brilique 90 mg twice daily is recommended for 12 months in ACS patients unless discontinuation is clinically indicated (see section 5.1).
Zdravljenje z zdravilom Brilique je treba začeti z enim 180-mg polnilnim odmerkom (dve tableti po 90 mg) in ga nadaljevati z 90 mg dvakrat na dan. Zdravljenje z zdravilom Brilique 90 mg dvakrat na dan je pri bolnikih z AKS priporočljivo nadaljevati 12 mesecev, razen če je prenehanje z zdravljenjem klinično indicirano (glejte poglavje 5.1).