natgillin/translations-raw huggingface dataset:
In 2.2% of patients taking ticagrelor and by 0.6% taking clopidogrel investigators considered the dyspnoea causally related to treatment in the PLATO study and few were serious (0.14% ticagrelor; 0.02% clopidogrel), (see section 4.4).
V študiji PLATO so raziskovalci dispnejo ocenili za vzročno povezano z uporabo zdravila pri 2,2 % bolnikov, ki so prejemali ticagrelor, in 0,6 % tistih, ki so prejemali klopidogrel in malo je bilo resnih (ticagrelor 0,14 %, klopidogrel 0,02 %) (glejte poglavje 4.4).
In patients that had moderate or severe elevation in one or more liver function tests at baseline, ticagrelor plasma concentrations were on average similar or slightly higher as compared to those without baseline elevations.
Farmakokinetičnih podatkov za bolnike z zmerno okvaro jeter ni. Bolniki z zmernim ali hudim izhodiščnim zvišanjem enega ali več jetrnih funkcijskih testov so imeli koncentracijo ticagrelorja v plazmi v povprečju podobno ali rahlo višjo kot tisti brez izhodiščnih zvišanj.
Available pharmacodynamic/toxicological data in animals have shown excretion of ticagrelor and its active metabolites in milk (see section 5.3).
Farmakodinamski in toksikološki podatki pri živalih kažejo, da se ticagrelor in njegovi aktivni presnovki izločajo v materinem mleku (glejte poglavje 5.3).
What Brilique contains • The active substance is ticagrelor.
Kaj vsebuje zdravilo Brilique • Učinkovina je ticagrelor.
In PLATO, patients on ticagrelor had a higher incidence of discontinuation due to adverse events than clopidogrel (7.4% vs. 5.4%).
V preskušanju PLATO je bila incidenca prekinitev zaradi neželenih učinkov med bolniki s ticagrelorjem večja (7,4 %) kot s klopidogrelom (5,4 %).
Cmax and AUC for ticagrelor were 12% and 23% higher in patients with mild hepatic impairment compared to matched healthy subjects, respectively, however, the IPA effect of ticagrelor was similar between the two groups.
Pri bolnikih z blago okvaro jeter je bila Cmax 12 % večja in AUC 23 % večja kot pri usklajenih zdravih preiskovancih, a je bil IPA učinek ticagrelorja v eni in drugi skupini podoben.
Spontaneous ICHs were reported in similar rates for ticagrelor 60 mg and ASA therapy alone (n=13, 0.2% in both treatment groups).
Spontane intrakranialne krvavitve so opažali v podobnih deležih med uporabo 60 mg ticagrelorja in med uporabo same ASA (n = 13, 0,2 % v obeh terapevtskih skupinah).
PLATO Total Major PLATO Major Fatal/Life-Threatening Non-CABG PLATO Major Non-Procedural PLATO Major PLATO Total Major + Minor Non-Procedural PLATO Major + Minor TIMI-defined Major TIMI-defined Major + Minor
PLATO hude s smrtnim izidom/smrtno nevarne PLATO hude, nepovezane s CABG PLATO hude, nepovezane s postopki PLATO vse hude in blage PLATO hude in blage, nepovezane s postopki Hude po opredelitvi TIMI Hude in blage po opredelitvi TIMI
Ticagrelor as crushed tablets mixed in water, given orally or administered through a nasogastric tube into the stomach, has a comparable bioavailability to whole tablets with regards to AUC and Cmax for ticagrelor and the active metabolite.
Ticagrelor v obliki zdrobljenih tablet, zmešanih z vodo, dan peroralno ali po nazogastrični sondi v želodec, ima podobno biološko uporabnost kot cele tablete, kar zadeva AUC in Cmax ticagrelorja in njegovega aktivnega presnovka.
The PLATO study included 18,624 patients who presented within 24 hours of onset of symptoms of unstable angina (UA), non ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI), and were initially managed medically, or with percutaneous coronary intervention (PCI), or with CABG.
Študija PLATO je vključila 18.624 bolnikov, pregledanih v 24 urah po začetku simptomov nestabilne angine pektoris (AP), miokardnega infarkta brez elevacije ST (NSTEMI) ali miokardnega infarkta z elevacijo ST (STEMI) ter so bili uvodoma zdravljeni farmakološko, s perkutanim koronarnim posegom (PCI) ali obvodno operacijo koronarnih arterij (CABG).
In PEGASUS, a reversible increase in mean serum uric acid levels of 6.3% and 5.6% was found for ticagrelor 90 mg and 60 mg, respectively, compared to a 1.5% decrease in the placebo group.
V študiji PEGASUS so ugotovili reverzibilno zvišanje povprečne koncentracije sečne kisline v serumu za 6,3 % z 90 mg ticagrelorja in za 5,6 % s 60 mg ticagrelorja, medtem ko se je v skupini s placebom znižala za 1,5 %.
Patients should be advised to inform physicians and dentists that they are taking ticagrelor before any surgery is scheduled and before any new medicinal product is taken.
Bolnikom je treba naročiti, da morajo pred načrtovanjem kakršnekoli operacije in preden vzamejo katerokoli novo zdravilo, zdravniku ali zobozdravniku povedati, da jemljejo ticagrelor.
• Moderate CYP3A4 inhibitors - Co-administration of diltiazem with ticagrelor increased the ticagrelor Cmax by 69% and AUC to 2.7-fold and decreased the active metabolite Cmax by 38% and AUC was unchanged.
• Zmerni zaviralci CYP3A4 - Sočasna uporaba diltiazema in ticagrelorja je povečala Cmax ticagrelorja za 69 % in njegovo AUC do 2,7-krat; Cmax aktivnega presnovka se je zmanjšala za 38 %, njegova AUC pa se ni spremenila.
• standard blisters (with sun/moon symbols) in cartons of 60 and 180 tablets
• standardnih pretisnih omotih (s simboloma sonce/mesec) v škatlah s 60 in 180 tabletami.
Information on concomitant treatment with ticagrelor is required for interpretation of HIT platelet function tests.
Za interpretacijo preiskave delovanja trombocitov v okviru diagnosticiranja HIT mora biti znan podatek o sočasnem zdravljenju s ticagrelorjem.
Blood creatinine increased
Preiskave zvišanje kreatinina v krvi
It reduces the chances of you having another heart attack, stroke or dying from a disease related to your heart or blood vessels.
Zdravilo zmanjša možnost ponovnega srčnega infarkta, možganske kapi ali smrti zaradi bolezni, povezanih s srcem ali ožiljem.
14 film-coated tablets 56 film-coated tablets 60 film-coated tablets 100x1 film-coated tablets 168 film-coated tablets 180 film-coated tablets
14 filmsko obloženih tablet 56 filmsko obloženih tablet 60 filmsko obloženih tablet 100x1 filmsko obložena tableta 168 filmsko obloženih tablet 180 filmsko obloženih tablet
• After this starting dose, the usual dose is one tablet of 90 mg twice a day for up to 12 months unless your doctor tells you differently.
• Po tem začetnem odmerku je običajen odmerek ena tableta 90 mg dvakrat na dan do 12
Ticagrelor and clopidogrel did not differ in non-CABG PLATO-defined Major Fatal/Lifethreatening bleeding, but PLATO-defined Total Major, TIMI Major, and TIMI Major + Minor bleeding were more common with ticagrelor.
Ticagrelor in klopidogrel se nista razlikovala po hudih krvavitvah s smrtnim izidom/smrtno nevarnih krvavitvah (po opredelitvi PLATO), nepovezanih s CABG, toda vse hude po opredelitvi PLATO, hude po TIMI ter hude + blage po TIMI pa so bile s ticagrelorjem pogostejše.
Post procedural haemorrhage, Traumatic bleedings e.g. bleeding from bladder cancer, gastric cancer, colon cancer e.g. increased tendency to bruise, spontaneous haematoma, haemorrhagic diathesis Identified in post-marketing experience d
Poškodbe, zastrupitve in zapleti pri posegih krvavitev po posegu, travmatska krvavitev a npr. krvavitev iz raka sečnega mehurja, raka želodca, raka kolona npr. večja nagnjenost k podplutbam, spontanim hematomom, hemoragični diatezi Ugotovljeni med uporabo po prihodu zdravila na trg d
Co-administration of rifampicin with ticagrelor decreased ticagrelor Cmax and AUC by 73% and 86%, respectively.
Sočasna uporaba rifampicina in ticagrelorja je zmanjšala Cmax ticagrelorja za 73 % in njegovo AUC za 86 %.
In PLATO, 42% of the 1584 patients (12% of cohort) who underwent coronary artery bypass graft (CABG) surgery had a PLATO Major Fatal/Life-threatening bleeding with no difference between treatment groups.
V študiji PLATO je imelo hude krvavitve s smrtnim izidom/smrtno nevarne krvavitve po merilih PLATO 42 % od 1584 bolnikov (12 % kohorte), ki jim je bila narejena obvodna operacija koronarnih arterij (CABG); med terapevtskima skupinama ni bilo razlik.
Ticagrelor is primarily a CYP3A4 substrate and a mild inhibitor of CYP3A4.
Ticagrelor je v prvi vrsti substrat CYP3A4 in blago zavira CYP3A4.
• perforated unit dose blisters in cartons of 10 x 1, 56 x 1 and 60 x 1 orodispersible tablets.
• perforiranih pretisnih omotih za enkratni odmerek v škatlah z 10 x 1, 56 x 1 in 60 x 1
• beta blockers and verapamil (used to treat high blood pressure)
• antagoniste adrenergičnih receptorjev beta in verapamil (uporabljajo se za zdravljenje visokega krvnega tlaka)
• PVC-PVDC/Al transparent calendar blister (with sun/moon symbols) of 14 tablets; cartons of 14 tablets (1 blister), 56 tablets (4 blisters) and 168 tablets (12 blisters).
• Prosojen koledarski pretisni omot (s simboloma sonce/mesec) iz PVC-PVDC/Al s 14 tabletami; škatle s 14 tabletami (1 pretisni omot), 56 tabletami (4 pretisni omoti) in 168 tabletami (12 pretisnih omotov).
How to take Brilique
Kako jemati zdravilo Brilique
EU/1/10/655/012 10 x 1 orodispersible tablets EU/1/10/655/013 56 x 1 orodispersible tablets EU/1/10/655/014 60 x 1 orodispersible tablets
EU/1/10/655/012 10 x 1 orodisperzibilna tableta EU/1/10/655/013 56 x 1 orodisperzibilna tableta EU/1/10/655/014 60 x 1 orodisperzibilna tableta
Ticagrelor 60 mg twice daily + ASA N=6958
Ticagrelor 60 mg dvakrat na dan + ASA N = 6958
• Strong CYP3A4 inhibitors - Co-administration of ketoconazole with ticagrelor increased the ticagrelor Cmax and AUC equal to 2.4-fold and 7.3-fold, respectively.
• Močni zaviralci CYP3A4 - Sočasna uporaba ketokonazola in ticagrelorja je povečala Cmax ticagrelorja za 2,4-krat in njegovo AUC za 7,3-krat.
No increased bleeding risk was seen for fatal bleeding and only a minor increase was observed in intracranial haemorrhages, as compared to ASA therapy alone.
V primerjavi z ASA samo ni bilo večjega tveganja za krvavitve s smrtnim izidom, tveganje za intrakranialne krvavitve pa se je povečalo le malo.
There were 6 fatal ICHs with ticagrelor 60 mg and 5 fatal ICHs with ASA therapy alone.
Med uporabo 60 mg ticagrelorja je bilo 6 intrakranialnih krvavitev s smrtnim izidom, med uporabo same ASA pa 5 intrakranialnih krvavitev s smrtnim izidom.
Major Fatal/Life-threatening Bleed: Clinically apparent with >50 g/L decrease in haemoglobin or ≥4 red cell units transfused; or fatal; or intracranial; or intrapericardial with cardiac tamponade; or with hypovolaemic shock or severe hypotension requiring pressors or surgery.
Huda krvavitev s smrtnim izidom/smrtno nevarna krvavitev: Klinično opazna z znižanjem hemoglobina > 50 g/l ali transfuzijo ≥ 4 enot eritrocitov, ali s smrtnim izidom, ali intrakranialna, ali intraperikardialna s tamponado srca, ali s hipovolemičnim šokom ali hudo hipotenzijo, ki zahteva uporabo presorjev ali operacijo.
PLATO Major Fatal/life-threatening: Fatal bleeding, OR any intracranial bleeding, OR intrapericardial with cardiac tamponade, OR with hypovolaemic shock or severe hypotension requiring pressors/inotropes or surgery OR clinically apparent with >50 g/L decrease in haemoglobin or ≥4 red cell units transfused.
Hude smrtne/smrtno nevarne po PLATO: Krvavitev s smrtnim izidom ALI katera koli intrakranialna krvavitev ALI intraperikardialna krvavitev s tamponado srca ALI hipovolemični šok ali huda hipotenzija, ki zahteva presorska/inotropna zdravila ali operacijo ALI klinično opazna z znižanjem hemoglobina za > 50 g/l ali transfuzijo ≥ 4 enot eritrocitov.
Ticagrelor 60 mg twice daily +ASA N = 7045
Ticagrelor 60 mg dvakrat na dan + ASA N = 7045
Figure 2 - Analysis of primary clinical composite endpoint of CV death, MI and stroke (PEGASUS)
Slika 2 - Analiza primarnega sestavljenega kliničnega opazovanega dogodka kardiovaskularne smrti, miokardnega infarkta in možganske kapi (PEGASUS)
• calendar blisters (with sun/moon symbols) in cartons of 14, 56 and 168 tablets
• koledarskih pretisnih omotih (s simboloma sonce/mesec) v škatlah s 14, 56 in 168 tabletami.
The inhibition of platelet aggregation (IPA) effect of ticagrelor was independent of dialysis in patients with end stage renal disease and similar to subjects with normal renal function (see section 4.2).
Učinek ticagrelorja na zavrtje agregacije trombocitov (IPA-inhibition of platelet aggregation) pri bolnikih s končno odpovedjo ledvic ni bil odvisen od dialize in je bil podoben kot pri osebah z normalnim delovanjem ledvic (glejte poglavje 4.2).
There is limited experience with ticagrelor in patients with moderate hepatic impairment, therefore, caution is advised in these patients (see sections 4.2 and 5.2).
Izkušenj s ticagrelorjem pri bolnikih z zmerno okvaro jeter je malo, zato je pri teh bolnikih potrebna previdnost (glejte poglavji 4.2 in 5.2).
Composite of CV Death/MI/Stroke
Sestavljeni: KV smrt/MI/ možganska kap
There was no effect of simvastatin on ticagrelor plasma levels.
Simvastatin ni vplival na koncentracijo ticagrelorja v plazmi.
• The other ingredients are: mannitol (E421), microcrystalline cellulose (E460), crospovidone (E1202), xylitol (E967), anhydrous calcium hydrogen phosphate (E341), sodium stearyl fumarate, hydroxypropylcellulose (E463), colloidal anhydrous silica.
• Druge sestavine zdravila so: manitol (E421), mikrokristalna celuloza (E460), krospovidon (E1202), ksilitol (E967), brezvodni kalcijev hidrogenfosfat (E341), natrijev stearilfumarat, hidroksipropilceluloza (E463), brezvodni koloidni silicijev dioksid.
Brilique contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially ‘sodium-free'.
Zdravilo Brilique vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
As in PLATO, most reported dyspnoea was mild to moderate in intensity (see section 4.4).
Tako kot v preskušanju PLATO je bila dispneja v večini zabeleženih primerov blaga do zmerna (glejte poglavje 4.4).
• A 2-fold increase of ticagrelor exposure was observed after daily consumption of large quantities of grapefruit juice (3x200 ml).
• Po vsakodnevnem zaužitju večjih količin grenivkinega soka (3x200 ml) je bilo opaženo 2-kratno povečanje izpostavljenosti ticagrelorju.
There was no effect of ticagrelor on cyclosporine blood levels.
Ticagrelor ni vplival na koncentracijo ciklosporina v krvi.
Ticagrelor and clopidogrel did not differ in rates of PLATO Major Fatal/Life-threatening bleeding, PLATO total Major bleeding, TIMI Major bleeding, or TIMI Minor bleeding (Table 2).
Ticagrelor in klopidogrel se nista razlikovala po deležih hudih krvavitev s smrtnim izidom/smrtno nevarnih krvavitvah po PLATO, vseh hudih krvavitev po PLATO, hudih krvavitev po TIMI in blagih krvavitev po TIMI (preglednica 2).
Brilique contains ticagrelor, a member of the chemical class cyclopentyltriazolopyrimidines (CPTP), which is an oral, direct acting, selective and reversibly binding P2Y12 receptor antagonist that prevents ADP-mediated P2Y12 dependent platelet activation and aggregation.
Ta učinkovina je peroralni, neposredno delujoči in selektivni antagonist receptorja P2Y12, na katerega se reverzibilno veže in prepreči z ADP posredovano, od P2Y12 odvisno, aktivacijo in agregacijo trombocitov.
Traumatic and procedural ICHs showed a minor increase with ticagrelor 60 mg treatment, (n=15, 0.2%) compared with ASA therapy alone (n=10, 0.1%).
Travmatskih in intrakralnialnih krvavitev po posegih je bilo malo več med uporabo 60 mg ticagrelorja (n = 15, 0,2 %) kot med uporabo same ASA (n = 10, 0,1 %).
History of myocardial infarction
Anamneza miokardnega infarkta
Major Other: Clinically apparent with 30-50 g/L decrease in haemoglobin or 2-3 red cell units transfused; or significantly disabling.
Hude druge: Klinično opazna z znižanjem hemoglobina 30-50 g/l ali transfuzijo 2-3 enot eritrocitov, ali povzroči pomembno okvaro.
The corresponding numbers in PEGASUS were 9.1%, 8.8% and 5.5% for ticagrelor 90 mg, 60 mg and placebo, respectively.
Ustrezne številke v študiji PEGASUS so bile 9,1 % z 90 mg ticagrelorja, 8,8 % s 60 mg ticagrelorja in 5,5 % s placebom.
PLATO Major
PLATO vse hude
False negative results in a platelet function test (to include, but may not be limited to the HIPA test) for HIT have been reported in patients administered ticagrelor.
Pri bolnikih, ki so prejemali ticagrelor, so poročali o lažno negativnih rezultatih preiskave delovanja trombocitov (to vključuje preiskavo HIPA, a morda ni omejeno le nanjo) za diagnosticiranje HIT.
Other TIMI Major: Non-fatal non-ICH TIMI Major bleeding.
Druge hude po TIMI: Hude krvavitve po TIMI, ki niso IKK in brez smrtnega izida.
EU/1/10/655/007 14 film-coated tablets EU/1/10/655/008 56 film-coated tablets EU/1/10/655/009 60 film-coated tablets EU/1/10/655/010 168 film-coated tablets EU/1/10/655/011 180 film-coated tablets
EU/1/10/655/007 14 filmsko obloženih tablet EU/1/10/655/008 56 filmsko obloženih tablet EU/1/10/655/009 60 filmsko obloženih tablet EU/1/10/655/010 168 filmsko obloženih tablet EU/1/10/655/011 180 filmsko obloženih tablet
EU/1/10/655/001 60 film-coated tablets EU/1/10/655/002 180 film-coated tablets EU/1/10/655/003 14 film-coated tablets EU/1/10/655/004 56 film-coated tablets EU/1/10/655/005 168 film-coated tablets EU/1/10/655/006 100x1 film-coated tablets
EU/1/10/655/001 60 filmsko obloženih tablet EU/1/10/655/002 180 filmsko obloženih tablet EU/1/10/655/003 14 filmsko obloženih tablet EU/1/10/655/004 56 filmsko obloženih tablet EU/1/10/655/005 168 filmsko obloženih tablet EU/1/10/655/006 100x1 filmsko obložena tableta
In the presence of digoxin, the Cmax and AUC of ticagrelor and its active metabolite were not affected.
Cmax in AUC ticagrelorja in njegovega aktivnega presnovka se v prisotnosti digoksina nista spremenili.
Patients with asthma/chronic obstructive pulmonary disease (COPD) may have an increased absolute risk of experiencing dyspnoea with ticagrelor.
Bolniki z astmo/kronično obstruktivno pljučno boleznijo (KOPB) imajo med uporabo ticagrelorja večje absolutno tveganje dispneje (glejte poglavje 4.8).
There was no effect of ticagrelor on diltiazem plasma levels.
Ticagrelor ni vplival na koncentracijo diltiazema v plazmi.
In PEGASUS, patients with history of MI with prior ischaemic stroke were not included.
Študija PEGASUS ni vključila bolnikov z anamnezo miokardnega infarkta s predhodno ishemično možgansko kapjo.
Ticagrelor 90 mg twice daily N=9235
Ticagrelor 90 mg dvakrat na dan n = 9235
Brilique-related breathlessness is generally mild and characterised as a sudden, unexpected hunger for air usually occurring at rest and may appear in the first weeks of therapy and for many may disappear.
Z zdravilom Brilique povezana zadihanost je praviloma blaga; značilen zanjo je nenaden, nepričakovan občutek pomanjkanja zraka, po navadi v mirovanju.
No dose adjustment is needed for patients with mild hepatic impairment.
Bolnikom z blago okvaro jeter odmerka ni treba prilagoditi.
Co-administration of cyclosporine (600 mg) with ticagrelor increased ticagrelor Cmax and AUC equal to 2.3-fold and 2.8-fold, respectively.
Sočasna uporaba ciklosporina (600 mg) in ticagrelorja je povečala Cmax ticagrelorja za 2,3-krat in njegovo AUC za 2,8-krat.
Exposure to ticagrelor was approximately 20% lower and exposure to the active metabolite was approximately 17% higher in patients with severe renal impairment (creatinine clearance <30 ml/min) compared to subjects with normal renal function.
Pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) je bila izpostavljenost ticagrelorju približno 20 % manjša in izpostavljenost njegovemu aktivnemu presnovku približno 17 % večja kot pri osebah z normalnim delovanjem ledvic.
e.g. conjunctival, retinal, intraocular bleeding e.g. epistaxis, haemoptysis e.g. gingival bleeding, rectal haemorrhage, gastric ulcer haemorrhage e.g. ecchymosis, skin haemorrhage, petechiae e.g. haemarthrosis, muscle haemorrhage e.g. haematuria, cystitis haemorrhagic e.g. vaginal haemorrhage, haematospermia, postmenopausal haemorrhage e.g. contusion, traumatic haematoma, traumatic haemorrhage
npr. veznična, mrežnična, znotrajočesna krvavitev npr. epistaksa, hemoptiza npr. krvavitev dlesni, rektalna krvavitev, krvavitev želodčnega ulkusa npr. ekhimoze, koža krvavitev, petehije npr. hemartroza, krvavitev v mišice npr. hematurija, hemoragični cistitis npr. krvavitev iz nožnice, hematospermija, pomenopavzalna krvavitev npr. kontuzija, travmatski hematom, travmatska krvavitev
PERFORATED UNIT DOSE BLISTER
PERFORIRANI PRETISNI OMOTI ZA ENKRATNI ODMEREK
No dose adjustment is recommended in patients with moderate hepatic impairment (see sections 4.2 and 4.4).
Bolnikom z zmerno okvaro jeter odmerka ni treba prilagoditi (glejte poglavji 4.2 in 4.4).
Tablet core: mannitol (E421), calcium hydrogen phosphate dihydrate, sodium starch glycolate type A, hydroxypropylcellulose (E463), magnesium stearate (E470b).
Jedro tablete: manitol (E421), kalcijev hidrogenfosfat dihidrat, natrijev karboksimetilškrob (vrsta A), hidroksipropilceluloza (E463), magnezijev stearat (E470b).
The corresponding numbers for gout/gouty arthritis in PEGASUS were 1.6%, 1.5% and 1.1% for ticagrelor 90 mg, 60 mg and placebo, respectively.
Ustrezne številke za protin/protinski artritis v študiji PEGASUS so bile 1,6 % z 90 mg ticagrelorja, 1,5 % s 60 mg ticagrelorja in 1,1 % s placebom.
TIMI Major Bleed: Clinically apparent with >50 g/L decrease in haemoglobin or intracranial haemorrhage.
Huda krvavitev po TIMI: Klinično opazna z znižanjem hemoglobina > 50 g/l ali intrakranialna krvavitev.
PLATO Major Other: Significantly disabling, OR clinically apparent with 30-50 g/L decrease in haemoglobin, OR 2-3 red cell units transfused.
Druge hude po PLATO: Pomembna, onesposabljajoča ALI klinično opazna z znižanjem hemoglobina 30-50 g/l ALI transfuzijo 2-3 enot eritrocitov.
Based on a population pharmacokinetic analysis of the PEGASUS study the median ticagrelor Cmax was 391 ng/ml and AUC was 3801 ng*h/ml at steady state for ticagrelor 60 mg. For ticagrelor 90 mg Cmax was 627 ng/ml and AUC was 6255 ng*h/ml at steady state.
Na podlagi populacijske farmakokinetične analize v študiji PEGASUS je bila med uporabo 60 mg ticagrelorja mediana Cmax v stanju dinamičnega ravnovesja 391 ng/ml in AUC 3801 ng*h/ml.
What Brilique looks like and contents of the pack The orodispersible tablets are round, flat, bevelled edged, white to pale pink, marked with a “90” above “TI” on one side.
Izgled zdravila Brilique in vsebina pakiranja Orodisperzibilne tablete so okrogle, ploščate, bele do bledo rožnate orodisperzibilne tablete s poševnim robom z oznako "90" nad "TI" na eni strani.
All-cause mortality, MI (excl. silent MI) or stroke
Možganska kap Umrljivost zaradi vseh vzrokov, MI (izklj.
Creatinine levels may increase during treatment with ticagrelor.
Med zdravljenjem s ticagrelorjem se koncentracija kreatinina lahko poveča.
For ticagrelor, 0.9% of patients discontinued study drug because of dyspnoea compared with 0.1% taking clopidogrel.
Zaradi dispneje je zdravljenje s ticagrelorjem prekinilo 0,9 % bolnikov, zdravljenje s klopidogrelom pa 0,1 % bolnikov.
• PVC-PVDC/Al perforated unit dose transparent blister of 10 tablets; cartons of 100x1 tablets (10 blisters).
• Prosojen perforiran pretisni omot za enkratni odmerek iz PVC-PVDC/Al z 10 tabletami; škatle s 100x1 tableto (10 pretisnih omotov).
ICH: Intracranial haemorrhage.
IKK: Intrakranialna krvavitev.
CV death, total MI, stroke, SRI, RI, TIA or other ATE All-cause mortality Definite stent thrombosis
nemi MI) ali možganska kap KV smrt, vsi MI, možganska kap, RPI, PI, TIA ali drugi ATD
Use of ticagrelor is contraindicated in patients with severe hepatic impairment (see sections 4.2 and 4.3).
Pri bolnikih s hudo okvaro jeter je uporaba ticagrelorja kontraindicirana (glejte poglavji 4.2 in 4.3).
Ticagrelor is a mild CYP3A4 inhibitor.
Ticagrelor blago zavira CYP3A4.
Tablet film-coating: hypromellose (E464), titanium dioxide (E171), macrogol 400, iron oxide black (E172), iron oxide red (E172).
Filmska obloga tablete: hipromeloza (E464), titanov dioksid (E171), makrogol 400, črni železov oksid (E172), rdeči železov oksid (E172).
What Brilique is used for
Za kaj uporabljamo zdravilo Brilique
Hyperuricaemia d Gout/Gouty Arthritis
Presnovne in prehranske motnje hiperurikemija d protin/protinski artritis