FrancophonIA/ELRC3.0 huggingface dataset:
English: In rabbits a slight delay in hepatic maturity and skeletal development was seen in foetuses from dams at high dose without showing maternal toxicity (safety margin of 4.5).
Slovenian: Pri kuncih so opazili rahel zaostanek jetrne zrelosti in razvoja okostja pri plodovih samic, ki so dobivale velike odmerke brez toksičnih učinkov na samice (varnostna meja 4,5).
English: 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.
Slovenian: Klinične farmakološke študije medsebojnega delovanja so pokazale, da sočasna uporaba tikagrelorja s heparinom, enoksaparinom in ASA ali dezmopresinom ni vplivala na farmakokinetiko tikagrelorja ali aktivnega presnovka; prav tako v primerjavi s tikagrelorjem ni vplivala na agregacijo trombocitov, izzvano z ADP.
English: 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.
Slovenian: 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.
English: • You are bleeding now or have bled recently inside your body, such as bleeding in your stomach or gut from an ulcer.
Slovenian: • če imate ali ste nedavno imeli notranjo krvavitev, npr. krvavitev v želodec ali črevo iz razjede.
English: • You are due to have surgery (including dental work) at any time while taking Possia.
Slovenian: • če imate predvideno operacijo (to velja tudi za zobozdravstvene posege) kadarkoli med jemanjem zdravila Possia.
English: Other possible side effects
Slovenian: Drugi možni neželeni učinki
English: For oral use.
Slovenian: Način uporabe Za peroralno uporabo.
English: Ticagrelor should be used with caution in patients with history of asthma and/or COPD (see section 4.4).
Slovenian: Tikagrelor je treba previdno uporabljati pri bolnikih z astmo in/ali KOPB (glejte poglavje 4.4).
English: Possia can be administered with or without food.
Slovenian: Zdravilo Possia se lahko jemlje s hrano ali brez nje.
English: 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.
Slovenian: Hudih, s CABG nepovezanih krvavitev po PLATO je bilo s tikagrelorjem 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.
English: Uric acid elevations: In PLATO, serum uric acid concentration increased to more than upper limit of normal in 22% of patients receiving ticagrelor compared to 13% of patients receiving clopidogrel.
Slovenian: Zvišanje sečne kisline: V študiji PLATO se je koncentracija sečne kisline v serumu povečala nad zgornjo normalno mejo pri 22 % bolnikov, ki so dobivali tikagrelor, in pri 13 % tistih, ki so dobivali klopidogrel.
English: Ticagrelor does not interact with the ADP binding site itself, but interacts with platelet P2Y12 ADP-receptor to prevent signal
Slovenian: Tikagrelor ne interagira z vezavnim mestom za ADP samim, temveč z interakcijo z ADP receptorjem P2Y12 prepreči prevajanje signalov.
English: Preclinical data for ticagrelor and its major metabolite have not demonstrated unacceptable risk for adverse effects for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity and genotoxic potential.
Slovenian: Predklinični podatki za tikagrelor in njegov glavni presnovek na podlagi običajnih študij varnostne farmakologije, toksičnosti enkratnih in ponavljajočih se odmerkov in genotoksičnega potenciala niso pokazali nesprejemljivega tveganja neželenih učinkov za človeka.
English: 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).
Slovenian: V primerjavi s klopidogrelom imajo lahko bolniki z astmo/KOPB, ki dobivajo tikagrelor, večje tveganje ne-resne dispneje (3,29 % s tikagrelorjem v primerjavi z 0,53 % s klopidogrelom) in resne dispneje (0,38 % s tikagrelorjem v primerjavi z 0,00 % s klopidogrelom).
English: • Atorvastatin - Co-administration of atorvastatin and ticagrelor increased atorvastatin acid Cmax by 23% and AUC by 36%.
Slovenian: • Atorvastatin - Sočasna uporaba atorvastatina in tikagrelorja je povečala Cmax atorvastatinske kisline za 23 % in njeno AUC za 36 %.
English: Creatinine elevations by >50% were more pronounced in patients > 75 years (ticagrelor 13.6% versus clopidogrel 8.8%), in patients with severe renal impairment at baseline (ticagrelor 17.8% versus clopidogrel 12.5%) and in patients receiving concomitant treatment with ARBs (ticagrelor 11.2% versus clopidogrel 7.1%).
Slovenian: Zvišanje kreatinina za > 50 % je bilo izrazitejše pri bolnikih, starejših od 75 let (tikagrelor 13,6 % v primerjavi s klopidogrelom 8,8 %), pri bolnikih z izhodiščno hudo okvaro ledvic (tikagrelor 17,8 % v primerjavi s klopidogrelom 12,5 %) in pri bolnikih, ki so sočasno dobivali antagoniste receptorjev angiotenzina (tikagrelor 11,2 % v primerjavi s klopidogrelom 7,1 %).
English: 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 coronary artery bypass grafting (CABG) (see section 4.1).
Slovenian: 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) (glejte poglavje 4.1).
English: Creatinine elevations: In PLATO, serum creatinine concentration significantly increased by >30% in 25.5% of patients receiving ticagrelor compared to 21.3% of patients receiving clopidogrel and by >50% in 8.3% of patients receiving ticagrelor compared to 6.7% of patients receiving clopidogrel.
Slovenian: Zvišanje kreatinina: V študiji PLATO se je koncentracija kreatinina v serumu značilno povečala za > 30 % pri 25,5 % bolnikov, ki so prejemali tikagrelor, in pri 21,3 % bolnikov, ki so prejemali klopidogrel, ter za > 50 % pri 8,3 % bolnikov, ki so prejemali tikagrelor, in pri 6,7 % bolnikov, ki so prejemali klopidogrel.
English: Do not take Possia if any of the above applies to you.
Slovenian: Ne vzemite zdravila Possia, če kaj od naštetega velja za vas.
English: Major Other: Clinically apparent with 30-50 g/l decrease in haemoglobin or 2-3 red cell units transfused; or significantly disabling.
Slovenian: Hude druge: Klinično opazna z znižanjem hemoglobina 30-50 g/l ali transfuzijo 2-3 enot eritrocitov, ali povzroči pomembno okvaro.
English: If you stop taking Possia, it may increase your chances of having another heart attack or stroke or dying from a disease related to your heart or blood vessels.
Slovenian: Če prenehate jemati zdravilo Possia, se vam lahko poveča možnost ponovnega srčnega infarkta, možganske kapi ali smrti zaradi bolezni, povezane s srcem ali ožiljem.
English: Tablet film coating: hypromellose (E464), titanium dioxide (E171), talc, polyethylene-glycol 400, and ferric oxide yellow (E172).
Slovenian: Filmska obloga tablete: hipromeloza (E464), titanov dioksid (E171), smukec, polietilenglikol 400 in rumeni železov oksid (E172).
English: Possia has not been studied in patients with moderate or severe hepatic impairment.
Slovenian: Zdravilo Possia ni raziskano pri bolnikih z zmerno do hudo okvaro jeter.
English: Ticagrelor is orally active, and reversibly interacts with the platelet P2Y12 ADP-receptor.
Slovenian: Tikagrelor je peroralno aktiven in reverzibilno interagira s trombocitnim ADP-receptorjem P2Y12.
English: In PLATO patients undergoing coronary artery bypass grafting (CABG), Possia 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).
Slovenian: Bolniki z obvodno operacijo koronarnih arterij (CABG) so imeli v študiji PLATO z zdravilom Possia več krvavitev kot s klopidogrelom, če so prenehali z jemanjem zdravila Possia 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).
English: There was no effect of ticagrelor on diltiazem plasma levels.
Slovenian: Tikagrelor ni vplival na koncentracijo diltiazema v plazmi.
English: There is currently no known antidote to reverse the effects of Possia, and Possia is not expected to be dialysable (see section 4.4).
Slovenian: Trenutno ni antidota, ki bi odpravil učinke zdravila Possia in zdravilo se z dializo ne odstrani (glejte poglavje 4.4).
English: AstraZeneca UK Limited Silk Road Business Park
Slovenian: AstraZeneca UK Limited Silk Road Business Park Macclesfield, Cheshire SK10 2NA Velika Britanija
English: Other CYP3A inducers (e.g. dexamethasone, phenytoin, carbamazepine and phenobarbital) would be expected to decrease the exposure to Possia as well.
Slovenian: Pričakovati je, da drugi induktorji CYP3A (npr. deksametazon, fenitoin, karbamazepin in fenobarbital) prav tako zmanjšajo izpostavljenost zdravilu Possia.
English: What you need to know before you take Possia
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Possia Ne jemljite zdravila Possia
English: There was no effect of simvastatin on ticagrelor plasma levels.
Slovenian: Simvastatin ni vplival na koncentracijo tikagrelorja v plazmi.
English: The primary route of ticagrelor elimination is via hepatic metabolism.
Slovenian: Primarna pot odstranjevanja tikagrelorja je presnova v jetrih.
English: The expiry date refers to the last day of that month.
Slovenian: Navodilo je bilo nazadnje revidirano dne
English: 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).
Slovenian: V akutni fazi je imelo ventrikularne pavze več bolnikov, ki so prejemali tikagrelor (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).
English: Ticagrelor as well as the active metabolite are P-gp substrates.
Slovenian: Tikagrelor in aktivni presnovek sta oba substrata P-gp.
English: 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.
Slovenian: Skupaj so se neželeni dogodki z dispnejo (dispneja, dispneja v mirovanju, dispneja med naporom, paroksizmalna nočna dispneja in nočna dispneja) pojavili pri 13,8 % bolnikov, zdravljenih s tikagrelorjem, in pri 7,8 % bolnikov, zdravljenih s klopidogrelom.
English: In the PLATO study, Possia was commonly administered with ASA, proton pump inhibitors, statins, beta-blockers, angiotensin converting enzyme 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).
Slovenian: V študiji PLATO so zdravilo Possia pogosto uporabljali z ASA, zaviralci protonske črpalke, statini, zaviralci 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).
English: The totality of renal AEs reported were 4.9% for ticagrelor vs. 3.8% for clopidogrel, however a similar percent of patients reported events considered by the investigators as causally related to treatment; 54 (0.6%) for ticagrelor and 43 (0.5%) for clopidogrel.
Slovenian: V celoti je bilo s tikagrelorjem 4,9 % neželenih učinkov in s klopidogrelom 3,8 %, toda po oceni raziskovalcev je bil z zdravilom vzročno povezan podoben odstotek učinkov, ki so jih navedli bolniki; 54 (0,6 %) med uporabniki tikagrelorja in 43 (0,5 %) med uporabniki klopidogrela.
English: • perforated blisters in a carton of 100x1 tablets
Slovenian: • perforirani pretisni omoti v škatli s 100 x 1 tableto.
English: If a patient reports new, prolonged or worsened dyspnoea this should be investigated fully and if not tolerated, treatment with Possia
Slovenian: Primere novonastale, dolgotrajne ali poslabšane dispneje je treba povsem raziskati; če je bolnik ne prenaša, je treba zdravljenje z zdravilom Possia končati.
English: The most commonly reported adverse reactions in patients treated with ticagrelor were dyspnoea, contusion and epistaxis and these reactions occurred at higher rates than in the clopidogrel treatment group.
Slovenian: Najpogosteje zabeleženi neželeni učinki med uporabo tikagrelorja so bili dispneja, zmedenost in epistaksa in so se pojavili z večjimi incidencami kot v skupini s klopidogrelom.
English: The mean trough digoxin levels were increased about 30% with ticagrelor co-administration with some individual maximum increases to 2 fold.
Slovenian: Sočasna uporaba tikagrelorja je povečala povprečno najmanjšo koncentracijo digoksina za približno 30 %, nekatera individualna največja povečanja pa so segala do 2-krat.
English: - If you have any further questions, ask your doctor or pharmacist.
Slovenian: • Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom ali s farmacevtom.
English: • the clot can cut off the blood supply completely - this can cause a heart attack (myocardial
Slovenian: • lahko strdek povsem prekine pretok krvi - posledica je lahko srčni infarkt (miokardni infarkt) ali možganska kap, ali
English: 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.
Slovenian: Povečanje števila holtersko ugotovljenih ventrikularnih pavz je bilo med uporabo tikagrelorja v primerjavi s klopidogrelom pri bolnikih s kroničnim srčnim popuščanjem v akutni fazi ACS večje kot v celotni študijski populaciji, ne pa tudi po enem mesecu.
English: Medicinal products metabolised by CYP3A4
Slovenian: Zdravila, ki se presnavljajo s CYP3A4
English: ADP-receptor that can prevent ADP-mediated platelet activation and aggregation.
Slovenian: Deluje na ADP-receptor P2Y12, ki lahko prepreči z ADP posredovano aktivacijo in agregacijo trombocitov.
English: Patients at risk for bradycardic events
Slovenian: Bolniki s tveganjem bradikardnih dogodkov
English: Blood creatinine increased
Slovenian: Preiskave zvišanje kreatina v krvi
English: Co-administration may lead to a substantial increase in Possia exposure (see section 4.5).
Slovenian: Sočasna uporaba lahko bistveno poveča izpostavljenost zdravilu Possia (glejte poglavje 4.5).
English: Gastrointestinal irritation was observed in several animal species at clinical relevant exposure levels (see section 4.8).
Slovenian: Pri več živalskih vrstah so ob klinično pomembnih ravneh izpostavljenosti opažali draženje prebavil (glejte poglavje 4.8).
English: Elderly patients No dose adjustment is required in elderly (see section 5.2).
Slovenian: Starejši bolniki Starejšim bolnikom odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: Rare (affects 1 to 10 users in 10,000)
Slovenian: Redki (pojavijo se pri 1 do 10 od 10.000 bolnikov)
English: Marketing Authorisation Holder: AstraZeneca AB S-151 85
Slovenian: Imetnik dovoljenja za promet: AstraZeneca AB S-151 85
English: There is a sun
Slovenian: simbol sonce/mesec
English: Co-administration of rifampicin with ticagrelor decreased ticagrelor Cmax and AUC by 73% and 86%, respectively.
Slovenian: Sočasna uporaba rifampicina in tikagrelorja je zmanjšala Cmax tikagrelorja za 73 % in njegovo AUC za 86 %.
English: Other
Slovenian: Drugo
English: Non-CABG related bleeding and non-procedural related bleeding: Possia and clopidogrel did not differ in non-CABG PLATO-defined Major Fatal/Life-threatening bleeding, but PLATO-defined Total Major, TIMI Major, and TIMI Major + Minor bleeding were more common with ticagrelor.
Slovenian: Krvavitve, nepovezane z obvodno operacijo koronarnih arterij in nepovezane s postopki: Zdravilo Possia 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 tikagrelorjem pogostejše.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of ticagrelor and its active metabolites in milk (see section 5.3).
Slovenian: Farmakodinamski in toksikološki podatki pri živalih kažejo, da se tikagrelor in njegovi aktivni presnovki izločajo v materinem mleku (glejte poglavje 5.3).
English: For gouty arthritis, the AEs reported were 0.2% for ticagrelor vs 0.1% for clopidogrel; none of these adverse events were assessed as
Slovenian: Za urični artritis so bili neželeni učinki opisani pri 0,2 % s tikagrelorjem in 0,1 % s klopidogrelom; raziskovalci nobenega od teh neželenih učinkov niso ocenili kot vzročno povezanega.
English: If you are not sure, talk to your doctor or pharmacist before taking Possia.
Slovenian: Če ste negotovi, se posvetujte s svojim zdravnikom ali s farmacevtom, preden vzamete zdravilo Possia.
English: Women of childbearing potential should use appropriate contraceptive measures to avoid pregnancy
Slovenian: Ženske v rodni dobi morajo med zdravljenjem z zdravilom Possia za preprečitev nosečnosti uporabljati ustrezno kontracepcijsko zaščito.
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or dentist before
Slovenian: Če kaj od naštetega velja za vas (ali če niste prepričani), se posvetujte s svojim zdravnikom, s farmacevtom ali zobozdravnikom, preden vzamete zdravilo Possia.
English: Possia affects cells called ‘platelets' (also called thrombocytes).
Slovenian: Zdravilo Possia vpliva na celice, ki jih imenujemo trombociti (ali krvne ploščice).
English: Common (affects 1 to 10 users in 100) • Bruising
Slovenian: Pogosti (pojavijo se pri 1 do 10 od 100 bolnikov) • podplutbe
English: The treatment effect of ticagrelor over clopidogrel appears consistent across many subgroups, including weight; sex; medical history of diabetes mellitus, transient ischaemic attack or nonhaemorrhagic 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).
Slovenian: Kot kaže, je ta terapevtski učinek tikagrelorja pred klopidogrelom stalen po številnih podskupinah, vključno s telesno maso, spolom, zdravstveno anamnezo ali sladkorno boleznijo, 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).
English: If clinically indicated, their concomitant use should be made with caution (see section 4.4).
Slovenian: Če so klinično indicirani, mora biti sočasna uporaba previdna (glejte poglavje 4.4).
English: • 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.
Slovenian: • Zmerni zaviralci CYP3A4 - Sočasna uporaba diltiazema in tikagrelorja je povečala Cmax tikagrelorja za 69 % in njegovo AUC do 2,7-krat; Cmax aktivnega presnovka se je zmanjšala za 38 %, njegova AUC pa se ni spremenila.
English: There were no adverse clinical consequences associated with this imbalance (including pacemaker insertions) in this population of patients.
Slovenian: S to razliko v tej populaciji bolnikov niso bile povezane kakšne neželene klinične posledice (vključno z vstavitvijo srčnega spodbujevalnika).
English: • 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.
Slovenian: • Močni zaviralci CYP3A4 - Sočasna uporaba ketokonazola in tikagrelorja je povečala Cmax tikagrelorja za 2,4-krat in njegovo AUC za 7,3-krat.
English: No data exist with Possia regarding a haemostatic benefit of platelet transfusions; circulating Possia may inhibit transfused platelets.
Slovenian: Podatkov o vplivu zdravila Possia na hemostatsko korist transfuzije trombocitov ni; zdravilo Possia v obtoku lahko zavre transfundirane trombocite.
English: CABG-related bleeding: 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.
Slovenian: Krvavitve, povezane z obvodno operacijo koronarnih arterij: 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.
English: Possia, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with Acute Coronary Syndromes (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).
Slovenian: Zdravilo Possia je sočasno z acetilsalicilno kislino (ASA) indicirano za preprečevanje aterotrombotičnih dogodkov pri odraslih bolnikih z akutnimi koronarnimi sindromi (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 ali obvodno koronarno operacijo.
English: 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).
Slovenian: V študiji PLATO so raziskovalci dispnejo ocenili za vzročno povezano z uporabo zdravila pri 2,2 % bolnikov, ki so prejemali tikagrelor, in 0,6 % tistih, ki so prejemali klopidogrel in malo je bilo resnih (tikagrelor 0,14 %, klopidogrel 0,02 %) (glejte poglavje 4.4).
English: Patients should be advised to inform physicians and dentists that they are taking Possia before any surgery is scheduled and before any new medicinal product is taken.
Slovenian: Bolnikom je treba naročiti, da morajo pred načrtovanjem kakršnekoli operacije in preden vzamejo katerokoli novo zdravilo, zdravniku ali zobozdravniku povedati, da jemljejo zdravilo Possia.