natgillin/translations-raw huggingface dataset:
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). 
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).
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. 
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.
Do not take Possia if any of the above applies to you. 
Ne vzemite zdravila Possia, če kaj od naštetega velja za vas.
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.
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. 
Če prenehate jemati zdravilo Possia, se vam lahko poveča možnost ponovnega srčnega infarkta, možganske kapi ali smrti zaradi bolezni, povezane s srcem ali ožiljem.
Tablet film coating: hypromellose (E464), titanium dioxide (E171), talc, polyethylene-glycol 400, and ferric oxide yellow (E172). 
Filmska obloga tablete: hipromeloza (E464), titanov dioksid (E171), smukec, polietilenglikol 400 in rumeni železov oksid (E172).
Possia has not been studied in patients with moderate or severe hepatic impairment. 
Zdravilo Possia ni raziskano pri bolnikih z zmerno do hudo okvaro jeter.
Ticagrelor is orally active, and reversibly interacts with the platelet P2Y12 ADP-receptor. 
Tikagrelor je peroralno aktiven in reverzibilno interagira s trombocitnim ADP-receptorjem P2Y12.
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). 
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).
There was no effect of ticagrelor on diltiazem plasma levels. 
Tikagrelor ni vplival na koncentracijo diltiazema v plazmi.
There is currently no known antidote to reverse the effects of Possia, and Possia is not expected to be dialysable (see section 4.4). 
Trenutno ni antidota, ki bi odpravil učinke zdravila Possia in zdravilo se z dializo ne odstrani (glejte poglavje 4.4).
AstraZeneca UK Limited Silk Road Business Park 
AstraZeneca UK Limited Silk Road Business Park Macclesfield, Cheshire SK10 2NA Velika Britanija
Other CYP3A inducers (e.g. dexamethasone, phenytoin, carbamazepine and phenobarbital) would be expected to decrease the exposure to Possia as well. 
Pričakovati je, da drugi induktorji CYP3A (npr. deksametazon, fenitoin, karbamazepin in fenobarbital) prav tako zmanjšajo izpostavljenost zdravilu Possia.
What you need to know before you take Possia 
Kaj morate vedeti, preden boste vzeli zdravilo Possia Ne jemljite zdravila Possia
There was no effect of simvastatin on ticagrelor plasma levels. 
Simvastatin ni vplival na koncentracijo tikagrelorja v plazmi.
The primary route of ticagrelor elimination is via hepatic metabolism. 
Primarna pot odstranjevanja tikagrelorja je presnova v jetrih.
The expiry date refers to the last day of that month. 
Navodilo je bilo nazadnje revidirano dne
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 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).
Ticagrelor as well as the active metabolite are P-gp substrates. 
Tikagrelor in aktivni presnovek sta oba substrata P-gp.
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 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.
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). 
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).
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. 
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.
• perforated blisters in a carton of 100x1 tablets 
• perforirani pretisni omoti v škatli s 100 x 1 tableto.
If a patient reports new, prolonged or worsened dyspnoea this should be investigated fully and if not tolerated, treatment with Possia 
Primere novonastale, dolgotrajne ali poslabšane dispneje je treba povsem raziskati; če je bolnik ne prenaša, je treba zdravljenje z zdravilom Possia končati.
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. 
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.
The mean trough digoxin levels were increased about 30% with ticagrelor co-administration with some individual maximum increases to 2 fold. 
Sočasna uporaba tikagrelorja je povečala povprečno najmanjšo koncentracijo digoksina za približno 30 %, nekatera individualna največja povečanja pa so segala do 2-krat.
- If you have any further questions, ask your doctor or pharmacist. 
• Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom ali s farmacevtom.
• the clot can cut off the blood supply completely - this can cause a heart attack (myocardial 
• lahko strdek povsem prekine pretok krvi - posledica je lahko srčni infarkt (miokardni infarkt) ali možganska kap, ali
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 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.
Medicinal products metabolised by CYP3A4 
Zdravila, ki se presnavljajo s CYP3A4
ADP-receptor that can prevent ADP-mediated platelet activation and aggregation. 
Deluje na ADP-receptor P2Y12, ki lahko prepreči z ADP posredovano aktivacijo in agregacijo trombocitov.
Patients at risk for bradycardic events 
Bolniki s tveganjem bradikardnih dogodkov
Blood creatinine increased 
Preiskave zvišanje kreatina v krvi
Co-administration may lead to a substantial increase in Possia exposure (see section 4.5). 
Sočasna uporaba lahko bistveno poveča izpostavljenost zdravilu Possia (glejte poglavje 4.5).
Gastrointestinal irritation was observed in several animal species at clinical relevant exposure levels (see section 4.8). 
Pri več živalskih vrstah so ob klinično pomembnih ravneh izpostavljenosti opažali draženje prebavil (glejte poglavje 4.8).
Elderly patients No dose adjustment is required in elderly (see section 5.2). 
Starejši bolniki Starejšim bolnikom odmerka ni treba prilagoditi (glejte poglavje 5.2).
Rare (affects 1 to 10 users in 10,000) 
Redki (pojavijo se pri 1 do 10 od 10.000 bolnikov)
Marketing Authorisation Holder: AstraZeneca AB S-151 85 
Imetnik dovoljenja za promet: AstraZeneca AB S-151 85
There is a sun 
simbol sonce/mesec
Co-administration of rifampicin with ticagrelor decreased ticagrelor Cmax and AUC by 73% and 86%, respectively. 
Sočasna uporaba rifampicina in tikagrelorja je zmanjšala Cmax tikagrelorja za 73 % in njegovo AUC za 86 %.
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. 
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.
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 tikagrelor in njegovi aktivni presnovki izločajo v materinem mleku (glejte poglavje 5.3).
For gouty arthritis, the AEs reported were 0.2% for ticagrelor vs 0.1% for clopidogrel; none of these adverse events were assessed as 
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.
If you are not sure, talk to your doctor or pharmacist before taking Possia. 
Če ste negotovi, se posvetujte s svojim zdravnikom ali s farmacevtom, preden vzamete zdravilo Possia.
Women of childbearing potential should use appropriate contraceptive measures to avoid pregnancy 
Ženske v rodni dobi morajo med zdravljenjem z zdravilom Possia za preprečitev nosečnosti uporabljati ustrezno kontracepcijsko zaščito.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or dentist before 
Če kaj od naštetega velja za vas (ali če niste prepričani), se posvetujte s svojim zdravnikom, s farmacevtom ali zobozdravnikom, preden vzamete zdravilo Possia.
Possia affects cells called ‘platelets' (also called thrombocytes). 
Zdravilo Possia vpliva na celice, ki jih imenujemo trombociti (ali krvne ploščice).
Common (affects 1 to 10 users in 100) • Bruising 
Pogosti (pojavijo se pri 1 do 10 od 100 bolnikov) • podplutbe
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). 
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).
If clinically indicated, their concomitant use should be made with caution (see section 4.4). 
Če so klinično indicirani, mora biti sočasna uporaba previdna (glejte poglavje 4.4).
• 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 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.
There were no adverse clinical consequences associated with this imbalance (including pacemaker insertions) in this population of patients. 
S to razliko v tej populaciji bolnikov niso bile povezane kakšne neželene klinične posledice (vključno z vstavitvijo srčnega spodbujevalnika).
• 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 tikagrelorja je povečala Cmax tikagrelorja za 2,4-krat in njegovo AUC za 7,3-krat.
No data exist with Possia regarding a haemostatic benefit of platelet transfusions; circulating Possia may inhibit transfused platelets. 
Podatkov o vplivu zdravila Possia na hemostatsko korist transfuzije trombocitov ni; zdravilo Possia v obtoku lahko zavre transfundirane trombocite.
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. 
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.
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). 
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.
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 tikagrelor, in 0,6 % tistih, ki so prejemali klopidogrel in malo je bilo resnih (tikagrelor 0,14 %, klopidogrel 0,02 %) (glejte poglavje 4.4).
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. 
Bolnikom je treba naročiti, da morajo pred načrtovanjem kakršnekoli operacije in preden vzamejo katerokoli novo zdravilo, zdravniku ali zobozdravniku povedati, da jemljejo zdravilo Possia.
• 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).
• rifampicin (an antibiotic), phenytoin, carbamazepine and phenobarbital (used to control seizures), dexamethasone (used to treat inflammatory and auto immune conditions), digoxin (used to treat heart failure), cyclosporin (used to lessen your body's defenses), quinidine and diltiazem (used to treat abnormal heart rhythms), beta blockers and verapamil (used to treat high 
• rifampicin (antibiotik), fenitoin, karbamazepin in fenobarbital (uporabljajo se za obvladovanje napadov krčev), deksametazon (uporablja se za zdravljenje vnetnih in avtoimunskih bolezni), digoksin (uporablja se za zdravljenje srčnega popuščanja), ciklosporin (uporablja se za zmanjševanje telesne obrambe), kinidin in diltiazem (uporabljata se za zdravljenje motenj srčnega ritma), zaviralce adrenergičnih receptorjev beta in verapamil (uporabljajo se za zdravljenje visokega krvnega tlaka).
Other clinically meaningful adverse reactions which may occur with overdose include dyspnoea and ventricular pauses (see section 4.8). 
Med drugimi klinično pomembnimi neželenimi učinki, ki se lahko pojavijo v primeru prevelikega odmerjanja, so dispneja in prekatne pavze (glejte poglavje 4.8).
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 Possia. 
Pričakovati je mogoče, da drugi zmerni zaviralci CYP3A4 (npr. amprenavir, aprepitant, eritromicin in flukonazol) vplivajo podobno in se jih prav tako lahko uporablja hkrati z zdravilom Possia.
Possia reduces the chances of you having another heart attack or a stroke or of dying from a disease related to your heart or blood vessels. 
Zdravilo Possia zmanjša možnost ponovnega srčnega infarkta, možganske kapi ali smrti zaradi bolezni, povezane s srcem ali ožiljem.
Patients with asthma/COPD may have an increased absolute risk of experiencing dyspnoea with Possia (see section 4.8). 
Bolniki z astmo/KOPB imajo med uporabo zdravila Possia večje absolutno tveganje dispneje (glejte poglavje 4.8).
Patients treated with clopidogrel can be directly switched to Possia if needed (see section 5.1). 
Če je treba, lahko bolniki, zdravljeni s klopidogrelom, neposredno preidejo na zdravilo Possia (glejte poglavje 5.1).
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see 
• Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov našteto v poglavju 6.1 (glejte poglavje 4.8).
Possia reduced the occurrence of the primary composite endpoint compared to clopidogrel in both the UA/NSTEMI and STEMI population (Table 3). 
Zdravilo Possia je zmanjšalo pojavljanje primarne sestavljene končne točke v primerjavi s klopidogrelom tako v populaciji z nestabilno angino pektoris/NSTEMI kot s STEMI (preglednica 3).
The Cmax and AUC of the active metabolite were reduced by 89% and 56%, respectively. 
Cmax aktivnega presnovka se je zmanjšala za 89 % in njegova AUC za 56 %.
• standard blisters (with sun/moon symbols) in cartons of 60 and 180 tablets 
• standardni pretisni omoti (s simboloma sonce/mesec) v škatlah s 60 in 180 tabletami.
In PLATO study, patients on ticagrelor had a higher risk of hyperuricaemia than those patients receiving clopidogrel (see section 4.8). 
V študiji PLATO je bilo tveganje hiperurikemije večje med zdravljenjem s tikagrelorjem kot med zdravljenjem s klopidogrelom (glejte poglavje 4.8).
PERFORATED UNIT DOSE BLISTER (100X1 TABLETS) 
PERFORIRANI PRETISNI OMOTI ZA ENKRATNI ODMEREK (100 x 1 TABLETA)
Other concomitant therapy 
Druga sočasna zdravila
If the association cannot be avoided, their concomitant use should be made with caution (see section 4.5). 
Če se hkratni uporabi ni mogoče izogniti, mora biti sočasno zdravljenje previdno (glejte poglavje 4.5).
Creatinine levels may increase during treatment with Possia (see section 4.8). 
Med zdravljenjem z zdravilom Possia se koncentracija kreatinina lahko poveča (glejte poglavje 4.8).
TIMI Minor Bleed: Clinically apparent with 30-50 g/l decrease in haemoglobin. 
Blaga krvavitev po TIMI: Klinično opazna z znižanjem hemoglobina 30-50 g/l.
Co-administration of ticagrelor with potent CYP3A inducers may decrease exposure and efficacy of ticagrelor (see section 4.4). 
Sočasna uporaba tikagrelorja z močnimi induktorji CYP3A lahko zmanjša izpostavljenost tikagrelorju in njegovo učinkovitost (glejte poglavje
What Possia is and what it is used for What you need to know before you take Possia 
Kaj je zdravilo Possia in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Possia Kako jemati zdravilo Possia Možni neželeni učinki
It is not recommended to use Possia if you are pregnant or may become pregnant. 
Zdravila Possia ni priporočljivo uporabljati, če ste noseči ali bi lahko zanosili.
Cmax and AUC for ticagrelor were 12% and 23% higher in patients with mild hepatic impairment compared to matched healthy subjects, respectively (see section 4.2). 
Pri bolnikih z blago okvaro jeter je bila Cmax 12 % večja in AUC 23 % večja kot pri usklajenih zdravih preiskovancih (glejte poglavje 4.2).
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.
Possia does not affect tests of 
Zdravilo Possia ne vpliva na teste delovanja pljuč.
- Keep this leaflet. 
• Navodilo shranite.
Due to reports of cutaneous bleeding abnormalities with SSRIs (e.g., paroxetine, sertraline and citalopram), caution is advised when administering SSRIs with Possia as this may increase the risk of 
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 zdravila Possia potrebna previdnost, ker lahko poveča tveganje krvavitev.
The concomitant use of Possia with doses of simvastatin or lovastatin greater than 40 mg is not recommended (see section 4.4). 
Sočasna uporaba zdravila Possia z odmerki simvastatina ali lovastatina, večjimi od 40 mg, ni priporočljiva (glejte poglavje 4.4).
In the presence of digoxin, the Cmax and AUC of ticagrelor and its active metabolite were not affected. 
Cmax in AUC tikagrelorja in njegovega aktivnega presnovka se v prisotnosti digoksina nista spremenili.
The concomitant use of Possia with doses of simvastatin or lovastatin greater than 40 mg is not recommended (see section 4.5). 
Sočasna uporaba zdravila Possia z odmerki simvastatina ali lovastatina, večjimi od 40 mg, ni priporočljiva (glejte poglavje 4.5).