FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: Other TIMI Major: Non-fatal non-ICH TIMI Major bleeding.
Slovenian: Druge hude po TIMI: Hude krvavitve po TIMI, ki niso IKK in brez smrtnega izida.
English: 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
Slovenian: 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
English: 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
Slovenian: 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
English: In the presence of digoxin, the Cmax and AUC of ticagrelor and its active metabolite were not affected.
Slovenian: Cmax in AUC ticagrelorja in njegovega aktivnega presnovka se v prisotnosti digoksina nista spremenili.
English: Patients with asthma/chronic obstructive pulmonary disease (COPD) may have an increased absolute risk of experiencing dyspnoea with ticagrelor.
Slovenian: Bolniki z astmo/kronično obstruktivno pljučno boleznijo (KOPB) imajo med uporabo ticagrelorja večje absolutno tveganje dispneje (glejte poglavje 4.8).
English: There was no effect of ticagrelor on diltiazem plasma levels.
Slovenian: Ticagrelor ni vplival na koncentracijo diltiazema v plazmi.
English: In PEGASUS, patients with history of MI with prior ischaemic stroke were not included.
Slovenian: Študija PEGASUS ni vključila bolnikov z anamnezo miokardnega infarkta s predhodno ishemično možgansko kapjo.
English: Ticagrelor 90 mg twice daily N=9235
Slovenian: Ticagrelor 90 mg dvakrat na dan n = 9235
English: 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.
Slovenian: Z zdravilom Brilique povezana zadihanost je praviloma blaga; značilen zanjo je nenaden, nepričakovan občutek pomanjkanja zraka, po navadi v mirovanju.
English: No dose adjustment is needed for patients with mild hepatic impairment.
Slovenian: Bolnikom z blago okvaro jeter odmerka ni treba prilagoditi.
English: Co-administration of cyclosporine (600 mg) with ticagrelor increased ticagrelor Cmax and AUC equal to 2.3-fold and 2.8-fold, respectively.
Slovenian: Sočasna uporaba ciklosporina (600 mg) in ticagrelorja je povečala Cmax ticagrelorja za 2,3-krat in njegovo AUC za 2,8-krat.
English: 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.
Slovenian: 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.
English: 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
Slovenian: 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
English: PERFORATED UNIT DOSE BLISTER
Slovenian: PERFORIRANI PRETISNI OMOTI ZA ENKRATNI ODMEREK
English: No dose adjustment is recommended in patients with moderate hepatic impairment (see sections 4.2 and 4.4).
Slovenian: Bolnikom z zmerno okvaro jeter odmerka ni treba prilagoditi (glejte poglavji 4.2 in 4.4).
English: Tablet core: mannitol (E421), calcium hydrogen phosphate dihydrate, sodium starch glycolate type A, hydroxypropylcellulose (E463), magnesium stearate (E470b).
Slovenian: Jedro tablete: manitol (E421), kalcijev hidrogenfosfat dihidrat, natrijev karboksimetilškrob (vrsta A), hidroksipropilceluloza (E463), magnezijev stearat (E470b).
English: 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.
Slovenian: 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.
English: TIMI Major Bleed: Clinically apparent with >50 g/L decrease in haemoglobin or intracranial haemorrhage.
Slovenian: Huda krvavitev po TIMI: Klinično opazna z znižanjem hemoglobina > 50 g/l ali intrakranialna krvavitev.
English: PLATO Major Other: Significantly disabling, OR clinically apparent with 30-50 g/L decrease in haemoglobin, OR 2-3 red cell units transfused.
Slovenian: Druge hude po PLATO: Pomembna, onesposabljajoča ALI klinično opazna z znižanjem hemoglobina 30-50 g/l ALI transfuzijo 2-3 enot eritrocitov.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: All-cause mortality, MI (excl. silent MI) or stroke
Slovenian: Možganska kap Umrljivost zaradi vseh vzrokov, MI (izklj.
English: Creatinine levels may increase during treatment with ticagrelor.
Slovenian: Med zdravljenjem s ticagrelorjem se koncentracija kreatinina lahko poveča.
English: For ticagrelor, 0.9% of patients discontinued study drug because of dyspnoea compared with 0.1% taking clopidogrel.
Slovenian: Zaradi dispneje je zdravljenje s ticagrelorjem prekinilo 0,9 % bolnikov, zdravljenje s klopidogrelom pa 0,1 % bolnikov.
English: • PVC-PVDC/Al perforated unit dose transparent blister of 10 tablets; cartons of 100x1 tablets (10 blisters).
Slovenian: • Prosojen perforiran pretisni omot za enkratni odmerek iz PVC-PVDC/Al z 10 tabletami; škatle s 100x1 tableto (10 pretisnih omotov).
English: ICH: Intracranial haemorrhage.
Slovenian: IKK: Intrakranialna krvavitev.
English: CV death, total MI, stroke, SRI, RI, TIA or other ATE All-cause mortality Definite stent thrombosis
Slovenian: nemi MI) ali možganska kap KV smrt, vsi MI, možganska kap, RPI, PI, TIA ali drugi ATD
English: Use of ticagrelor is contraindicated in patients with severe hepatic impairment (see sections 4.2 and 4.3).
Slovenian: Pri bolnikih s hudo okvaro jeter je uporaba ticagrelorja kontraindicirana (glejte poglavji 4.2 in 4.3).
English: Ticagrelor is a mild CYP3A4 inhibitor.
Slovenian: Ticagrelor blago zavira CYP3A4.
English: Tablet film-coating: hypromellose (E464), titanium dioxide (E171), macrogol 400, iron oxide black (E172), iron oxide red (E172).
Slovenian: Filmska obloga tablete: hipromeloza (E464), titanov dioksid (E171), makrogol 400, črni železov oksid (E172), rdeči železov oksid (E172).
English: What Brilique is used for
Slovenian: Za kaj uporabljamo zdravilo Brilique
English: Hyperuricaemia d Gout/Gouty Arthritis
Slovenian: Presnovne in prehranske motnje hiperurikemija d protin/protinski artritis
English: In patients with stable coronary artery disease (CAD) on ASA, ticagrelor demonstrates a rapid onset of pharmacological effect as demonstrated by a mean inhibition of platelet aggregation (IPA) for ticagrelor at 0.5 hours after 180 mg loading dose of about 41%, with the maximum IPA effect of 89% by 2-4 hours post dose, and maintained between 2-8 hours.
Slovenian: To se kaže s povprečno 41 % zavrtjem agregacije trombocitov (IPAinhibition of platelet aggregation) 0,5 ure po 180-mg polnilnem odmerku ticagrelorja in največjim učinkom IPA 89 % v 2 do 4 urah po odmerku in se ohrani od 2 do 8 ur.
English: Clopidogrel
Slovenian: Ticagrelor Klopidogrel
English: TIMI Major or Minor
Slovenian: Hude ali blage po TIMI
English: Discontinuation of treatment due to bleeding was more common with ticagrelor 60 mg compared to ASA therapy alone (6.2% and 1.5%, respectively).
Slovenian: Prekinitev zdravljenja zaradi krvavitev je bila med uporabo 60 mg ticagrelorja pogostejša (6,2 %) kot med uporabo same ASA (1,5 %).
English: Tablet film-coating: hypromellose (E464), titanium dioxide (E171), talc, macrogol 400, iron oxide yellow (E172).
Slovenian: Filmska obloga tablete: hipromeloza (E464), titanov dioksid (E171), smukec, makrogol 400, rumeni železov oksid (E172).
English: Round, flat, bevelled edged, white to pale pink, orodispersible tablets marked with ‘90' above ‘TI' on one side and plain on the other.
Slovenian: Okrogla, ploščata, bela do bledo rožnata orodisperzibilna tableta s poševnimi robovi, z oznako "90" nad "TI" na eni strani in brez oznak na drugi strani.
English: Brilique helps stop the clumping of platelets.
Slovenian: Zdravilo Brilique pomaga preprečiti sprijemanje trombocitov.
English: TIMI Minor Bleed: Clinically apparent with 30-50 g/L decrease in haemoglobin.
Slovenian: Blaga krvavitev po TIMI: Klinično opazna z znižanjem hemoglobina 30-50 g/l.
English: Round, biconvex, pink tablets marked with ‘60' above ‘T' on one side and plain on the other.
Slovenian: Okrogla, bikonveksna, rožnata tableta z oznako "60" nad "T" na eni strani in brez oznak na drugi strani.
English: Therefore, appropriate clinical and/or laboratory monitoring is recommended when giving narrow therapeutic index P-gp dependent medicinal products like digoxin concomitantly with ticagrelor.
Slovenian: Zato je med sočasno uporabo ticagrelorja in zdravil, ki so odvisna od P-gp in imajo ozek terapevtski indeks (kakršno je digoksin), priporočljiv ustrezen klinični in/ali laboratorijski nadzor (glejte poglavje 4.4).
English: Fatal/Life-threatening
Slovenian: Smrtne/smrtno nevarne Druge hude po PLATO
English: Reproductive system and breast disorders
Slovenian: Motnje reprodukcije in dojk krvavitve v reproduktivnih organih
English: Relative to ASA alone, ticagrelor 60 mg twice daily significantly reduced the primary composite endpoint of CV death, MI and stroke.
Slovenian: Ticagrelor 60 mg dvakrat na dan je v primerjavi s samo ASA značilno zmanjšal primarni sestavljeni opazovani dogodek kardiovaskularne smrti, miokardnega infarkta in možganske kapi.
English: However, more PLATO combined Major + Minor bleeding occurred with ticagrelor compared with clopidogrel.
Slovenian: Med uporabo ticagrelorja pa se je pojavilo več hudih + blagih krvavitev po PLATO kot med uporabo klopidogrela.
English: Co-administration of ticagrelor with tolbutamide resulted in no change in the plasma levels of either medicinal product, which suggests that ticagrelor is not a CYP2C9 inhibitor and unlikely to alter the CYP2C9 mediated metabolism of medicinal products like warfarin and tolbutamide.
Slovenian: To kaže, da ticagrelor ne zavira CYP2C9 in tako ni verjetno, da bi spremenil presnovo drugih zdravil, npr. varfarina in tolbutamida, s CYP2C9.
English: During the Holter substudy in PLATO, more patients had ventricular pauses >3 seconds with ticagrelor than with clopidogrel during the acute phase of their ACS.
Slovenian: V holterski podštudiji PLATO je imelo med akutno fazo AKS ventrikularne pavze, ≥ 3 sekund, več bolnikov, ki so dobivali ticagrelor, kot bolnikov, ki so dobivali klopidogrel.
English: In patients with ACS, it is recommended that renal function is also checked one month after initiating the treatment with ticagrelor, paying special attention to patients ≥75 years, patients with moderate/severe renal impairment and those receiving concomitant treatment with an angiotensin receptor blocker (ARB).
Slovenian: Posebno pozornost je treba nameniti bolnikom, starim ≥ 75 let, bolnikom z zmerno/hudo okvaro ledvic in tistim, ki sočasno prejemajo antagoniste receptorjev angiotenzina.
English: The PEGASUS TIMI-54 study was a 21,162 patient, event-driven, randomised, double-blind, placebo-controlled, parallel group, international multicentre study to assess the prevention of atherothrombotic events with ticagrelor given at 2 doses (either 90 mg twice daily or 60 mg twice daily) combined with low dose ASA (75-150 mg), compared to ASA therapy alone in patients with history of MI and additional risk factors for atherothrombosis.
Slovenian: Njen namen je bil oceniti preprečevanje aterosklerotičnih dogodkov s ticagrelorjem, uporabljenim v dveh odmerkih (ali 90 mg dvakrat na dan ali 60 mg dvakrat na dan) v kombinaciji z nizkim odmerkom ASA (75-150 mg), v primerjavi s samo ASA pri bolnikih z anamnezo miokardnega infarkta in dodatnimi dejavniki tveganja za aterotrombozo.
English: Blood disorder bleedings
Slovenian: Bolezni sečil krvavitev v sečilih
English: Higher exposures to ticagrelor and the active metabolite were observed in women compared to men.
Slovenian: Pri ženskah so v primerjavi z moškimi ugotovili večjo izpostavljenost ticagrelorju in njegovemu aktivnemu presnovku.
English: Brilique 90 mg orodispersible tablets
Slovenian: Brilique 90 mg orodisperzibilne tablete
English: Patients self-identified as black had an 18% lower bioavailability of ticagrelor compared to Caucasian patients, in clinical pharmacology studies, the exposure (Cmax and AUC) to ticagrelor in Japanese subjects was approximately 40% (20% after adjusting for body weight) higher compared to that in Caucasians.
Slovenian: V kliničnih farmakoloških študijah je bila izpostavljenost (Cmax in AUC) ticagrelorju pri japonskih preiskovancih približno 40 % večja (20 % večja po korekciji za telesno maso) kot pri belcih.
English: • Bleeding gums
Slovenian: • krvavitev iz dlesni
English: Psychiatric disorders
Slovenian: Psihiatrične motnje zmedenost
English: Mean serum uric acid increased approximately 15% with ticagrelor compared to approximately 7.5% with clopidogrel and after treatment was stopped, decreased to approximately 7% on ticagrelor but with no decrease observed for clopidogrel.
Slovenian: Povprečna koncentracija sečne kisline v serumu se je s ticagrelorjem povečala za približno 15 % in s klopidogrelom za približno 7,5 %.
English: Higher exposures to ticagrelor (approximately 25% for both Cmax and AUC) and the active metabolite were observed in elderly (≥75years) ACS patients compared to younger patients by the population pharmacokinetic analysis.
Slovenian: Pri starejših osebah (≥ 75 let) z AKS so v primerjavi z mlajšimi s populacijsko farmakokinetično analizo ugotovili večjo izpostavljenost ticagrelorju (približno 25 % za Cmax in AUC) in njegovemu aktivnemu presnovku.
English: • Bleeding from your stomach lining (ulcer)
Slovenian: • slabost v želodcu (siljenje na bruhanje)
English: Brilique 60 mg twice daily is the recommended dose when an extended treatment is required for patients with a history of MI of at least one year and a high risk of an atherothrombotic event (see section 5.1).
Slovenian: 60 mg zdravila Brilique dvakrat na dan je priporočen odmerek, če je potrebno podaljšano zdravljenje pri bolnikih, ki imajo anamnezo miokardnega infarkta vsaj eno leto in veliko tveganje za aterotrombotične dogodke (glejte poglavje 5.1) Zdravljenje se lahko pri bolnikih z ASA in velikim tveganjem za aterotrombotične dogodke začne brez prekinitve kot nadaljevalno zdravljenje po začetnem enoletnem zdravljenju z 90 mg zdravila Brilique ali drugim zaviralcem receptorjev adenozindifosfata (ADP).
English: However, no evidence of clinically significant adverse reactions was observed in the PLATO trial after concomitant administration with one or more medicinal products known to induce bradycardia (e.g. 96% beta blockers, 33% calcium channel blockers diltiazem and verapamil and 4% digoxin) (see section 4.5).
Slovenian: Vendar pa v preskušanju PLATO po sočasni uporabi z enim ali več zdravili, za katera je znano, da povzročajo bradikardijo (npr. 96 % antagonisti adrenergičnih receptorjev beta, 33 % zaviralca kalcijevih kanalčkov diltiazem in verapamil ter 4 % digoksin) niso ugotovili klinično pomembnih neželenih učinkov (glejte poglavje 4.5).
English: Ear haemorrhage
Slovenian: Okvara ledvic
English: However, no evidence of clinically significant adverse reactions was observed in the PLATO trial after concomitant administration with one or more medicinal products known to induce bradycardia (e.g. 96% beta blockers, 33% calcium channel blockers diltiazem and verapamil and 4% digoxin).
Slovenian: Vendar pa v preskušanju PLATO po sočasni uporabi z enim ali več zdravili, za katera je znano, da povzročajo bradikardijo (npr. 96 % antagonisti adrenergičnih receptorjev beta, 33 % zaviralca kalcijevih kanalčkov diltiazem in verapamil ter 4 % digoksin) niso ugotovili klinično pomembnih neželenih učinkov.
English: Each film-coated tablet contains 60 mg ticagrelor.
Slovenian: Ena filmsko obložena tableta vsebuje 60 mg ticagrelorja.
English: On a background of daily ASA, ticagrelor 90 mg twice daily showed superiority to 75 mg daily clopidogrel in preventing the composite endpoint of CV death, MI or stroke, with the difference driven by CV death and MI.
Slovenian: Ob vsakodnevnem jemanju ASA je bil ticagrelor v odmerku 90 mg dvakrat na dan superioren od 75 mg klopidogrela na dan pri preprečevanju sestavljenega opazovanega dogodka (kardiovaskularna
English: Both 60 mg twice daily and 90 mg twice daily regimens of ticagrelor in combination with ASA were superior to ASA alone in the prevention of atherothrombotic events (composite endpoint: CV death, MI and stroke), with a consistent treatment effect over the entire study period, yielding a 16% RRR and 1.27% ARR for ticagrelor 60 mg and a 15% RRR and 1.19% ARR for ticagrelor 90 mg.
Slovenian: Shemi s ticagrelorjem 60 mg dvakrat na dan in 90 mg dvakrat na dan v kombinaciji z ASA sta bili za preprečevanje aterotrombotičnih dogodkov (sestavljeni opazovani dogodek: kardiovaskularna smrt, miokardni infarkt in možganska kap) superiorni nad samo ASA z doslednim terapevtskim učinkom med celotnim obdobjem študije.
English: Marketing Authorisation Holder: AstraZeneca AB SE-151 85 Södertälje Sweden
Slovenian: Imetnik dovoljenja za promet: AstraZeneca AB SE-151 85 Södertälje Švedska
English: Brilique 60 mg film-coated tablets
Slovenian: Brilique 60 mg filmsko obložene tablete
English: Each orodispersible tablet contains 90 mg ticagrelor.
Slovenian: Ena orodisperzibilna tableta vsebuje 90 mg ticagrelorja.
English: Subcutaneous or dermal bleeding h, Rash,
Slovenian: Bolezni kože in podkožja podkožne ali kožne krvavitve h, izpuščaj, srbenje
English: • Diarrhoea or indigestion
Slovenian: • driska ali težave s prebavo
English: No clinically relevant effect on oral contraceptive efficacy is expected when levonorgestrel and ethinyl estradiol are co-administered with ticagrelor.
Slovenian: Med sočasno uporabo levonorgestrela in etinilestradiola s ticagrelorjem ni pričakovati klinično pomembnega vpliva na učinkovitost peroralnih kontraceptivov.
English: Renal impairment No dose adjustment is necessary for patients with renal impairment (see section 5.2).
Slovenian: Okvara ledvic Bolnikom z okvaro ledvic odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: Intracranial haemorrhage
Slovenian: tumorske krvavitve
English: Brilique is not likely to affect your ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo Brilique vplivalo na sposobnost upravljanja vozil in strojev.
English: Tablet coating Titanium dioxide (E171) Iron oxide black (E172) Iron oxide red (E172) Macrogol 400
Slovenian: Obloga tablete titanov dioksid (E171) črni železov oksid (E172) rdeči železov oksid (E172) makrogol 400 hipromeloza (E464)
English: Musculoskeletal connective tissue and bone
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva krvavitev v mišice
English: Calcium hydrogen phosphate dihydrate Magnesium stearate (E470b) Sodium starch glycolate type A Hydroxypropylcellulose (E463)
Slovenian: Jedro tablete manitol (E421) kalcijev hidrogenfosfat dihidrat magnezijev stearat (E470b) natrijev karboksimetilškrob (vrsta A) hidroksipropilceluloza (E463)
English: Each film-coated tablet contains 90 mg ticagrelor.
Slovenian: Ena filmsko obložena tableta vsebuje 90 mg ticagrelorja.
English: Ticagrelor has not been studied in patients with severe hepatic impairment and there is no pharmacokinetic information in patients with moderate hepatic impairment.
Slovenian: Ticagrelor ni raziskan pri bolnikih s hudo okvaro jeter.
English: Brilique 60 mg tablets ticagrelor
Slovenian: Brilique 60 mg tablete ticagrelor
English: Brilique 90 mg film-coated tablets
Slovenian: Brilique 90 mg filmsko obložene tablete
English: There was no evidence of benefit (no reduction in the primary composite endpoint of CV death, MI and stroke, but an increase in major bleeding) when ticagrelor 60 mg twice daily was introduced in clinically stable patients >2 years from the MI, or more than one year after stopping previous ADP receptor inhibitor treatment (see also section 4.2).
Slovenian: Če so 60 mg ticagrelorja dvakrat na dan uvedli klinično stabilnim bolnikom več kot 2 leti po miokardnem infarktu ali več kot eno leto po prenehanju zdravljenja s predhodnim zaviralcem receptorjev ADP, niso ugotovili koristi (nobenega zmanjšanja primarnega sestavljenega opazovanega dogodka, ki je obsegal kardiovaskularno smrt, miokardni infarkt in možgansko kap, a porast hudih krvavitev) (glejte tudi poglavje 4.2).
English: Brilique 60 mg film-coated tablets ticagrelor
Slovenian: Brilique 60 mg filmsko obložene tablete ticagrelor
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema krvavitve zaradi bolezni krvi trombotična trombocitopenična purpura
English: Safety Endpoints
Slovenian: Opazovani dogodki varnosti
English: Brilique 90 mg orodispersible tablets ticagrelor
Slovenian: Brilique 90 mg orodisperzibilne tablete ticagrelor
English: What Brilique looks like and contents of the pack Film-coated tablet (tablet): The tablets are round, biconvex, pink, film-coated marked with a “60” above “T” on one side.
Slovenian: Filmsko obložena tableta (tableta): Tablete so okrogle, na obeh straneh izbočene, rožnate filmsko obložene tablete z oznako "60" nad "T" na eni strani.
English: As a precautionary measure, the use of ticagrelor in patients with uric acid nephropathy is discouraged.
Slovenian: Iz previdnosti zato ticagrelorja ni priporočljivo uporabljati pri bolnikih z urično nefropatijo.