natgillin/translations-raw huggingface dataset:
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake "EXP".
Platelets are blood cells that help with normal blood clotting.
Trombociti (krvne ploščice) so celice, ki pomagajo pri normalnem strjevanju krvi.
This medicinal product does not require any special temperature storage conditions.
Za shranjevanje zdravila niso potrebna posebna navodila glede temperature.
Studies in rats have shown vorapaxar and/or its metabolites are excreted in milk.
Študije na podganah so pokazale, da se vorapaksar in/ali njegovi presnovki izločajo v mleko.
• have a bodyweight of less than 60 kg
• če imate telesno maso manjšo od 60 kg,
The apparent terminal half-life for vorapaxar is 187 hours (range 115-317 hours) and is similar for the active metabolite.
Navidezni končni razpolovni čas vorapaksarja je 187 ur (razpon: od 115 do 317 ur) in je podoben tudi pri aktivnem presnovku.
Film-coated tablet 7 film-coated tablets 10 x 1 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 x 1 film-coated tablets 100 film-coated tablets
filmsko obložena tableta 7 filmsko obloženih tablet 10 x 1 filmsko obložena tableta 28 filmsko obloženih tablet 30 filmsko obloženih tablet 50 x 1 filmsko obložena tableta 100 filmsko obloženih tablet
The median duration of treatment with vorapaxar was 823 days (interquartile range: 645-1016 days).
Mediano trajanje zdravljenja z vorapaksarjem je znašalo 823 dni (interkvartilni razpon: 645 - 1.016 dni).
The recommended dose is one tablet by mouth each day taken with or without food.
Priporočeni odmerek je ena tableta na dan, s hrano ali brez nje.
There are limited data on the efficacy and safety of Zontivity beyond 24 months.
Podatkov o učinkovitosti in varnosti zdravila Zontivity po 24 mesecih je malo.
* K-M estimate at 1,080 days
* Ocena po K-M po 1.080 dneh.
Vorapaxar is also a substrate of CYP2J2; therefore, there is a potential for potent inhibitors of CYP2J2 to result in increases in vorapaxar exposure.
Vorapaksar je tudi substrat CYP2J2, zato obstaja možnost, da močni zaviralci CYP2J2 povečajo izpostavljenost vorapaksarju.
Bleeding events were treated in the same manner as for other antiplatelet agents including addressing the source of bleeding while providing supportive care.
Krvavitve so zdravili enako kot pri drugih antiagregacijskih zdravilih, vključno z obravnavo vira krvavitve med zagotavljanjem podporne oskrbe.
Pharmacokinetics of vorapaxar are similar between elderly, including those ≥75 years of age, and younger patients.
Farmakokinetika vorapaksarja je pri starejših bolnikih, vključno s tistimi, ki so stari ≥ 75 let, podobna kot pri mlajših.
Zontivity is indicated for the reduction of atherothrombotic events in adult patients with
Zdravilo Zontivity je indicirano za zmanjšanje aterotrombotičnih dogodkov pri odraslih bolnikih
Evaluation of Zontivity on QTc interval
Ocena vpliva zdravila Zontivity na interval QTc
• if you have unusual bleeding now, such as bleeding in your brain, stomach or gut
• če imate trenutno kakšno neobičajno krvavitev, na primer krvavitev v možganih, želodcu ali črevesju,
The primary route of elimination is through the faeces, with approximately 91.5% of radiolabeled dose predicted to be recovered in the faeces compared to 8.5% in the urine.
Glavna pot izločanja je z blatom; predvidoma se približno 91,5 % radioaktivno označenega odmerka pojavi v blatu, v primerjavi z 8,5 % v urinu.
However, if a patient is to undergo elective surgery, if clinically feasible, Zontivity should be discontinued at least 30 days prior to surgery.
Če ima bolnik predviden elektivni kirurški poseg in če je klinično izvedljivo, je treba uporabo zdravila Zontivity prekiniti vsaj 30 dni pred kirurškim posegom.
Age, gender, weight and race were included as factors assessed in the population pharmacokinetic model to evaluate vorapaxar pharmacokinetics in healthy subjects and patients:
Starost, spol, telesna masa in rasa so bili kot faktorji vključeni v populacijski farmakokinetični model za oceno farmakokinetike vorapaksarja pri zdravih osebah in pri bolnikih:
The systemic exposure of M20 is ~20% of the exposure to vorapaxar.
Sistemska izpostavljenost presnovku M20 je ~20 % izpostavljenosti vorapaksarju.
What Zontivity is and what it is used for What you need to know before you take Zontivity
Kaj je zdravilo Zontivity in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Zontivity
Do not take Zontivity if any of the above apply to you.
Ne vzemite zdravila Zontivity, če kaj od naštetega velja za vas.
Among the common bleeding events, epistaxis is the most frequent.
Med pogostimi krvavitvami je bila najpogostejša epistaksa.
Vorapaxar is a weak inhibitor of the intestinal P-glycoprotein (P-gp) transporter.
Vorapaksar je šibek zaviralec črevesnega P-glikoproteinskega (P-gp) prenašalca.
Tell all of your doctors and dentists that you are taking Zontivity.
Vsem svojim zdravnikom in zobozdravnikom morate povedati, da jemljete zdravilo Zontivity.
• bleeding from cuts or wounds that is more than normal
• krvavitve iz ureznin ali ran, ki so močnejše kot po navadi
• The active substance is vorapaxar sulfate.
• Zdravilna učinkovina je vorapaksarjev sulfat.
• bleeding in your eye
• krvavitev v oko
Excipient(s) with known effect: Each film-coated tablet contains 66.12 mg of lactose (as monohydrate).
Pomožne snovi z znanim učinkom: Ena filmsko obložena tableta vsebuje 66,12 mg laktoze (v obliki monohidrata).
Patients with events*
Bolniki z dogodki*
Effects of other medicinal products on vorapaxar
Vpliv drugih zdravil na vorapaksar
Due to the unknown potential for adverse reactions in breast-feeding infants from Zontivity, discontinue breast-feeding or discontinue Zontivity; taking into account the importance of the medicinal product to the mother.
Zaradi neznane možnost neželenih učinkov zdravila Zontivity pri dojenih dojenčkih je treba bodisi prekiniti dojenje bodisi ukiniti zdravilo Zontivity, upoštevaje pomembnost zdravila za mater.
Zontivity should be initiated at least 2 weeks after a MI and preferably within the first 12 months from the acute event (see section 5.1).
Zdravilo Zontivity je treba uvesti vsaj 2 tedna po MI in po možnosti v prvih 12 mesecih po akutnem dogodku (glejte poglavje 5.1).
Vorapaxar is eliminated primarily by metabolism, with significant contribution by CYP3A.
Vorapaksar se izloča predvsem s presnovo, v kateri pomembno sodeluje CYP3A.
However, if it is within 12 hours of the next dose, skip the missed dose.
Če je do naslednjega odmerka manj kot 12 ur, pozabljeni odmerek izpustite.
Incidence (%)
Pojavnost (%)
Follow your doctor's instructions about stopping Zontivity.
Upoštevajte zdravnikova navodila glede prenehanja uporabe zdravila Zontivity.
It is not known if Zontivity will harm your unborn baby.
Ni znano, ali zdravilo Zontivity škoduje nerojenemu otroku.
Bleeding should be suspected in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), or other surgical procedures, even if the patient does not have any signs of bleeding.
Na krvavitev je treba posumiti pri vsakem bolniku, ki je hipotenziven in je imel pred kratkim opravljeno koronarno angiografijo, perkutano koronarno intervencijo (PCI - percutaneous coronary intervention), obvodno operacijo koronarnih arterij (CABG - coronary artery bypass grafting) ali druge kirurške posege, tudi če bolnik nima nobenih znakov krvavitve.
The recommended dose of Zontivity is 2.08 mg to be taken once daily.
Priporočeni odmerek zdravila Zontivity je 2,08 mg enkrat na dan.
Bleeding time was prolonged slightly with administration of acetylsalicylic acid alone or in combination with vorapaxar.
Čas krvavitve se je rahlo podaljšal z uporabo acetilsalicilne kisline same ali v kombinaciji z vorapaksarjem.
Pre and postnatal studies in rats only showed some inconsistent developmental effects at exposures sufficiently in excess of human exposure at the RHD of 2.08 mg vorapaxar.
Pre- in postnatalne študije pri podganah so pokazale le nekaj nekonsistentnih razvojnih učinkov pri izpostavljenostih, ki so dovolj presegale izpostavljenost pri človeku pri RHD 2,08 mg vorapaksarja.
General risk of bleeding
Splošno tveganje za krvavitve
It is not known whether vorapaxar is excreted in human breast milk.
Ni znano, ali se vorapaksar izloča v materino mleko pri človeku.
Severe bleeding is uncommon, but can be life threatening.
Huda krvavitev se pojavi občasno, vendar je lahko življenjsko nevarna.
General risk factors for bleeding include older age (however, no dose adjustment is necessary in the elderly (see section 5.2)), low body weight, and reduced renal or hepatic function.
Splošni dejavniki tveganja za krvavitve so višja starost (vendar starejšim odmerka ni treba prilagoditi (glejte poglavje 5.2)), nizka telesna masa in zmanjšano delovanje ledvic ali jeter.
Patients were randomized to receive daily treatment with 2.5 mg vorapaxar sulfate (n=13,225) or placebo (n=13,224) in addition to other standard therapy.
Bolnike so randomizirali na vsakodnevno jemanje 2,5 mg vorapaksarjevega sulfata (n = 13.225) ali placeba (n = 13.224) poleg drugega standardnega zdravljenja.
Zontivity has no or negligible influence on the ability to drive and use machines.
Zdravilo Zontivity nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Acetylsalicylic acid, vorapaxar, and clopidogrel in combination produced significant prolongation of bleeding time.
Acetilsalicilna kislina, vorapaksar in klopidogrel so v kombinaciji bistveno podaljšali čas krvavitve.
• if you have had bleeding in the brain
• če ste imeli krvavitev v možganih,
Zontivity increases the risk of bleeding in proportion to the patient's underlying bleeding risk.
Zdravilo Zontivity poveča tveganje za krvavitve sorazmerno z bolnikovim osnovnim tveganjem zanje.
Transfusion of human platelet rich plasma normalised bleeding times with partial recovery of ex vivo platelet aggregation induced with arachidonic acid, but not induced with ADP or TRAP.
Transfuzija plazme, bogate s človeškimi trombociti, je normalizirala čas krvavitve in je dosegla delno obnovo agregacije trombocitov ex vivo, sprožene z arahidonsko kislino, ne pa sprožene z ADP ali TRAP.
The percentages of patients who underwent CABG surgery and had CABG-related bleeds are shown in Table 3.
Odstotki bolnikov, pri katerih so opravili CABG in so imeli s posegom povezane krvavitve, so prikazani v preglednici 3.
What you need to know before you take Zontivity
Kaj morate vedeti, preden boste vzeli zdravilo Zontivity
Zontivity increases the risk of bleeding, including ICH and sometimes fatal bleeding.
Zdravilo Zontivity poveča tveganje za krvavitve, vključno z ICH in v nekaterih primerih za krvavitve s smrtnim izidom.
The overall no effect level for the pre- and postnatal development effects was 5 mg/kg/day (6.8-times [female animals] the human steady-state exposure at 2.5 mg/day).
Celoten odmerek, ki ni imel vpliva na pre- in post-natalne razvojne učinke je znašal 5 mg/kg/dan (6,8-kratnik [samice živali] izpostavljenosti v stanju dinamičnega ravnovesja pri človeku pri odmerku 2,5 mg/dan).
The effect of Zontivity on GUSTO severe or moderate bleeding relative to placebo was shown to be consistent across the subgroups examined.
Učinek zdravila Zontivity na hude ali zmerne krvavitve po GUSTO je bil v primerjavi s placebom konsistenten v vseh raziskanih podskupinah.
The tablet may be taken with or without food.
Tableta se lahko jemlje s hrano ali brez nje.
The effects of renal (end-stage renal disease undergoing haemodialysis) and hepatic impairment on the pharmacokinetics of vorapaxar were evaluated in specific pharmacokinetic studies and are summarized below:
Vpliv okvare ledvic (končna odpoved ledvic na dializi) in okvare jeter na farmakokinetiko vorapaksarja so ocenili v specifičnih farmakokinetičnih študijah in so povzeti v nadaljevanju:
Your doctor will also give you instructions about acetylsalicylic acid or clopidogrel (other anti-platelet agents) that you may need to take with Zontivity.
Zdravnik vam bo dal tudi navodila glede acetilsalicilne kisline ali klopidogrela (drugi zdravili proti strjevanju krvi), ki ju boste morda morali jemati z zdravilom Zontivity.
Vorapaxar is eliminated primarily in the form of metabolites, with no vorapaxar detected in urine.
Vorapaksar se izloči predvsem v obliki presnovkov in v urinu ni zaznavnega vorapaksarja.
Includes all CV Death, MI, Stroke and GUSTO severe events up to each timepoint as indicated in the table.
Vključuje vse CV smrti, MI, možgansko kap in hude dogodke po opredelitvi GUSTO do časovne točke, navedene v preglednici.
As vorapaxar is highly protein-bound, haemodialysis is unlikely to be effective in the treatment of an overdose.
Ker je vorapaksar v veliki meri vezan na beljakovine, ni verjetno, da bi bila hemodializa učinkovita za zdravljenje prevelikega odmerjanja.
Vorapaxar is a selective and reversible inhibitor of the PAR-1 receptors on platelets that are activated by thrombin.
Vorapaksar je selektiven in reverzibilen zaviralec trombocitnih receptorjev PAR-1, ki jih aktivira trombin.
Based on population pharmacokinetic analysis using data from healthy subjects and patients with atherosclerotic disease, vorapaxar mean AUC is estimated to be higher in patients with mild (17%) and moderate (34%) renal impairment compared to those with normal renal function; these differences are not considered to be clinically relevant.
Na podlagi populacijske farmakokinetične analize podatkov zdravih preiskovancev in bolnikov z aterosklerotično boleznijo ocenjujejo, da je povprečna AUC vorapaksarja višja pri bolnikih z blago (17 %) in zmerno (34 %) okvaro ledvic kot pri tistih z normalnim delovanjem ledvic; te razlike niso klinično pomembne.
The treatment effect of vorapaxar on the primary and key secondary endpoints was shown to be durable and persistent over the length of the TRA 2°P - TIMI 50 study.
Učinek zdravljenja z vorapaksarjem na primarne in ključne sekundarne opazovane dogodke se je izkazal za obstojnega in trajnega med celotnim trajanjem študije TRA 2°P - TIMI 50.
In humans, vorapaxar has been administered in single doses up to 120 mg and daily doses of 5 mg for up to 4 weeks without observation of dose-associated adverse events or identification of a specific risk.
Pri ljudeh so vorapaksar uporabili v enkratnih odmerkih do 120 mg in dnevnih odmerkih 5 mg do 4 tedne, ne da bi opazili z odmerkom povezane neželene učinke ali ugotovili kakšno specifično tveganje.
• boceprevir, telaprevir (used to treat hepatitis C virus infections)
• boceprevir, telaprevir (uporabljata se za zdravljenje okužb z virusom hepatitisa C),
Co-administration with vorapaxar did not alter the single-dose pharmacokinetics of rosiglitazone (8 mg), a CYP2C8 substrate not marketed in the EU.
Sočasna uporaba vorapaksarja ni spremenila farmakokinetike enkratnega odmerka rosiglitazona (8 mg), substrata CYP2C8, ki ni na trgu EU.
In post-MI and PAD patients, the median duration of treatment with Zontivity in these patients was 2.5 years (up to 4 years).
Pri bolnikih po MI in PAD je bilo mediano trajanje zdravljenja z zdravilom Zontivity 2,5 let (do 4 leta).
• vomiting blood or your vomit looks like ‘coffee grounds'
• bruhanje krvi ali pa je izbruhana vsebina videti kot "kavna usedlina"
Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excluding heparin, ATC code: B01AC26.
Farmakoterapevtska skupina: antitrombotiki, zaviralci agregacije trombocitov brez heparina Oznaka ATC: B01AC26.
Other medicines and Zontivity
Druga zdravila in zdravilo Zontivity
Vorapaxar and the major circulating active metabolite, M20, are extensively bound (≥99%) to human plasma proteins.
Vorapaksar in njegov glavni aktivni presnovek v obtoku, M20, sta v humani plazmi v veliki meri (≥ 99 %) vezana na beljakovine.
If your doctor prescribes you prasugrel or ticagrelor, you should stop Zontivity and talk to your doctor.
Če vam zdravnik predpiše prasugrel ali tikagrelor, morate prenehati jemati zdravilo Zontivity in se posvetovati z zdravnikom.
TRA 2°P - TIMI 50 was a multicenter, randomized, double-blind, placebo-controlled study conducted in patients who had evidence or a history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems.
Študija TRA 2°PTIMI 50 je bila multicentrična, randomizirana, dvojno slepa, s placebom nadzorovana študija pri bolnikih, ki so imeli znake ali anamnezo ateroskleroze s prizadetostjo koronarnega, možganskega ali perifernega ožilja.
A patient who misses a dose of Zontivity should skip the missed dose if it is within 12 hours of the next scheduled dose and take the next dose at the regular scheduled time.
Bolnik, ki izpusti odmerek zdravila Zontivity, do naslednjega predvidenega odmerka pa je manj kot 12 ur, mora izpuščeni odmerek preskočiti in naslednji odmerek vzeti ob rednem predvidenem času.
Medicinal products that increase gastric pH
Zdravila, ki zvišujejo pH v želodcu
Phase 3 data suggest that co-administration of a weak or moderate CYP3A inhibitor with vorapaxar does not increase bleeding risk or alter the efficacy of vorapaxar.
Podatki iz faze 3 kažejo, da sočasna uporaba šibkega ali zmernega zaviralca CYP3A z vorapaksarjem ne poveča tveganja za krvavitve in ne spremeni učinkovitosti vorapaksarja.
Patients with events
Bolniki z dogodki
No dose adjustment is necessary (see section 4.4).
Prilagoditev odmerka ni potrebna (glejte poglavje 4.4).
The systemic pharmacokinetics of vorapaxar are linear with accumulation (6-fold) predictable from single- to multiple-dose data.
Sistemska farmakokinetika vorapaksarja je linearna, s predvidenim kopičenjem (6-kratnim) na podlagi podatkov o enkratnih in večkratnih odmerkih.
In the cohort of post-MI or PAD patients with no history of stroke or TIA, the net clinical outcome analysis based on multiple occurrences of endpoints (CV Death/MI/Stroke/GUSTO Severe) is constant over time at each of the censoring times examined (12, 18, 24, 30, and 36 months) at cumulative 6-month intervals.
V skupini bolnikov po MI ali PAD brez anamneze možganske kapi ali TIA, je analiza neto kliničnih izidov na podlagi večkratnih pojavov končnih dogodkov (CV smrt/MI/možganska kap/GUSTO resni dogodki) konstantna v vsaki ocenjevani časovni točki (12, 18, 24, 30 in 36 mesecev) v 6-mesečnih intervalih.
The composite of cardiovascular death, MI, and stroke were assessed as secondary endpoint.
Sestavljeni dogodek srčno-žilne smrti, MI in možganske kapi je bil ocenjen kot sekundarni opazovani dogodek.
Zontivity may be taken with or without food.
Zdravilo Zontivity se lahko jemlje s hrano ali brez nje.
The duration of platelet inhibition is dose and concentration dependent.
Trajanje zaviranja trombocitov je odvisno od odmerka in koncentracije.
Bleeding was the most common adverse reaction leading to study drug discontinuation for both treatments (3.0% for Zontivity and 1.8% for placebo).
V obeh primerih je bila krvavitev najpogostejši neželeni učinek, ki je povzročil prenehanje uporabe raziskovanega zdravila (Zontivity 3,0 %, placebo 1,8 %).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
No dosage adjustment of digoxin or Zontivity is recommended.
Prilagoditev odmerka digoksina ali zdravila Zontivity ni potrebna.
Based on results of pre-clinical studies that investigated bleeding while on vorapaxar on the background of acetylsalicylic acid and clopidogrel, it may be possible to restore hemostasis by administering exogenous platelets.
Na osnovi rezultatov predkliničnih študij, kjer so preučevali krvavitev med uporabo vorapaksarja skupaj z acetilsalicilno kislino in klopidogrelom, je hemostazo morda mogoče ponovno vzpostaviti z dajanjem eksogenih trombocitov.
What Zontivity is and what it is used for
Kaj je zdravilo Zontivity in za kaj ga uporabljamo
Effects of vorapaxar on other medicinal products
Vpliv vorapaksarja na druga zdravila
• if you have ever had a stroke or ‘mini stroke' (also called a ‘transient ischemic attack' or TIA)
• če ste kdaj imeli možgansko kap ali "mini kap" (imenujejo jo tudi "tranzitorna ishemična ataka"
• dying from a heart attack
• smrt zaradi srčnega infarkta,
EU/1/14/976/001 7 film-coated tablets EU/1/14/976/002 10 x 1 film-coated tablets (unit-dose) EU/1/14/976/003 28 film-coated tablets EU/1/14/976/004 30 film-coated tablets EU/1/14/976/005 50 x 1 film-coated tablets (unit-dose) EU/1/14/976/006 100 film-coated tablets
EU/1/14/976/001 7 filmsko obloženih tablet EU/1/14/976/002 10 x 1 filmsko obložena tableta EU/1/14/976/003 28 filmsko obloženih tablet EU/1/14/976/004 30 filmsko obloženih tablet EU/1/14/976/005 50 x 1 filmsko obložena tableta EU/1/14/976/006 100 filmsko obloženih tablet
• have had bleeding problems in the past
• če ste imeli v preteklosti težave s krvavitvami,
Concomitant use of Zontivity with strong (potent) inducers of CYP3A (e.g., rifampin, carbamazepine and phenytoin) should be avoided.
Sočasni uporabi zdravila Zontivity in močnih induktorjev CYP3A (npr. rifampina, karbamazepina in fenitoina) se je treba izogibati.
The combination of vorapaxar with warfarin or other oral anticoagulants may increase the risk of bleeding and should be avoided.
Sočasna uporaba vorapaksarja in varfarina ali drugih peroralnih antikoagulantov lahko poveča tveganje za krvavitve in se ji je treba izogibati.
Vorapaxar does not inhibit platelet aggregation induced by other agonists such as adenosine diphosphate (ADP), collagen or a thromboxane mimetic.
Vorapaksar ne zavira agregacije trombocitov, sprožene z drugimi agonisti, kot so adenozin-difosfat (ADP), kolagen ali tromboksanski mimetik.
Platelet poor plasma had no effect on bleeding times or platelet aggregation.
S trombociti revna plazma ni vplivala na čas krvavitve ali agregacijo trombocitov.
Zontivity has been shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization (UCR).
Ugotovljeno je, da zdravilo Zontivity zmanjša delež kombiniranega opazovanega dogodka srčno-žilnih smrti, MI, možganske kapi in nujne koronarne revaskularizacije (UCR - urgent coronary revascularization).
Ingestion of vorapaxar with a high-fat meal resulted in no meaningful change in AUC with a small (21%) decrease in Cmax and delayed tmax (45 minutes).
Zaužitje vorapaksarja z zelo mastnim obrokom ni pomembno spremenilo AUC, je pa nekoliko (21 %) zmanjšalo Cmax in podaljšalo tmax (45 minut).
• inflammation of the stomach
• vnetje želodca
• nefazodone (used to treat depression)
• nefazodon (uporablja se za zdravljenje depresije),
This is because it is not known if Zontivity passes into your breast milk.
Ni namreč znano, ali zdravilo Zontivity prehaja v materino mleko.
Although the TRA 2°P - TIMI 50 trial was not designed to evaluate the relative benefit of Zontivity in individual patient subgroups, the benefit was most apparent in patients who were enrolled on the basis of a recent MI as indicated by a history of spontaneous MI ≥2 weeks but 12 months prior (post-MI or PAD patient population) with no history of stroke or TIA.
Čeprav preskušanje TRA 2°P - TIMI 50 ni bilo namenjeno ugotavljanju relativne koristi zdravila Zontivity v posameznih podskupinah bolnikov, je bila korist najbolj očitna pri bolnikih, vključenih zaradi nedavnega MI, tj. z anamnezo spontanega MI ≥ 2 tedna, toda  12 mesecev prej (populacija bolnikov po MI ali PAD) in brez možganske kapi ali TIA v anamnezi.
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine.
Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden vzamete to zdravilo.