natgillin/translations-raw huggingface dataset:
Call your doctor straight away if you have any of these symptoms of a stroke, which is uncommon:
Takoj pokličite zdravnika, če imate katerega od naslednjih simptomov možganske kapi, ki se pojavi občasno:
For patients being started on Zontivity due to symptomatic PAD, therapy may be initiated at any time.
Pri bolnikih, ki bodo prejeli zdravilo Zontivity zaradi simptomatske PAD, se lahko terapijo uvede kadar koli.
Withholding Zontivity for a brief period will not be useful in preventing or managing an acute bleeding event because of its long half-life (see section 5.2).
Kratkotrajna prekinitev jemanja zdravila Zontivity za preprečevanje in obvladovanje akutne krvavitve zaradi dolge razpolovne dobe zdravila ni uporabna (glejte poglavje 5.2).
Elderly No dose adjustment is necessary in the elderly (see sections 4.4 and 5.2).
Starejši Pri starejših odmerka ni treba prilagajati (glejte poglavji 4.4 in 5.2).
Vorapaxar is eliminated by metabolism, with CYP3A4 and CYP2J2 responsible for formation of M20, its major active circulating metabolite, and M19, the predominant metabolite identified in excreta.
Vorapaksar se odstrani s presnovo; CYP3A4 in CYP2J2 sta odgovorna za nastajanje M20, glavnega aktivnega presnovka vorapaksarja v obtoku, in M19, prevladujočega presnovka, ugotovljenega v izločkih.
Pharmacokinetics of vorapaxar are similar between patients with mild (Child Pugh, 5 to 6 points) to moderate (Child Pugh, 7 to 9 points) hepatic impairment and healthy patients.
Farmakokinetika vorapaksarja je pri bolnikih z blago (Child Pugh od 5 do 6 točk) do zmerno (Child Pugh od 7 do 9 točk) okvaro jeter in zdravih osebah podobna.
Strong CYP3A inducers
Močni induktorji CYP3A
If you forget to take Zontivity
Če ste pozabili vzeti zdravilo Zontivity
Zontivity contains an active substance called vorapaxar, and it belongs to a group of medicines called ‘anti-platelet medicines.'
Zdravilo Zontivity vsebuje zdravilno učinkovino, imenovano vorapaksar, in spada v skupino zdravil, imenovanih "antiagregacijska zdravila - zdravila proti strjevanju krvi".
C. OTHER CONDITIONS AND REQUIREMENTS OF THE
C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
Hazard Ratio (95% CI)
Razmerje tveganj (95 % IZ )
If a dose is missed:
V primeru izpuščenega odmerka:
In the cohort of post-MI or PAD patients with no history of stroke or TIA, the findings for the primary and key secondary composite endpoints are consistent with the overall population (see Figure 1 and Table 4).
V kohorti bolnikov po MI ali PAD, ki v anamnezi niso imeli možganske kapi ali TIA, so bili izsledki glede primarnega in ključnih sekundarnih sestavljenih opazovanih dogodkov skladni s celotno populacijo (glejte sliko 1 in preglednico 4).
Patients taking Zontivity should also take acetylsalicylic acid with or without clopidogrel according to their indications or standard of care.
Bolniki, ki jemljejo zdravilo Zontivity, morajo jemati tudi acetilsalicilno kislino, s klopidogrelom ali brez njega, v skladu z njunimi indikacijami ali standardno oskrbo.
The treatment effect of Zontivity was consistent with the overall results across many subgroups, including sex; age; renal insufficiency; medical history of diabetes mellitus; tobacco use; concomitant therapies at baseline including thienopyridine, acetylsalicylic acid, and statins.
Učinek zdravljenja z zdravilom Zontivity je bil v skladu s celotnimi rezultati v številnih podskupinah, vključno po spolu, starosti, insuficienci ledvic, anamnezi sladkorne bolezni, uporabi tobaka in izhodiščnih sočasnih zdravil, vključno s tienopiridinom, acetilsalicilno kislino in statini.
No effects on fertility were observed in animal studies (see section 5.3).
V študijah na živalih niso opazili vplivov na plodnost (glejte poglavje 5.3).
Severe hepatic impairment increases the risk of bleeding; therefore, the use of Zontivity in these patients is contraindicated (see sections 4.2 and 5.2).
Huda okvara jeter povečuje tveganje za krvavitve, zato je uporaba zdravila Zontivity pri teh bolnikih kontraindicirana (glejte poglavji 4.2 in 5.2).
Call your doctor straight away, if you have any of these signs or symptoms of bleeding while taking Zontivity:
Takoj pokličite zdravnika, če imate med jemanjem zdravila Zontivity katerega od naslednjih znakov ali simptomov krvavitve:
If you take more Zontivity than you are supposed to, talk to a doctor or go to hospital straight away.
Če ste vzeli večji odmerek zdravila Zontivity, kot bi smeli Če vzamete več zdravila Zontivity, kot je predvideno, se takoj posvetujte z zdravnikom ali pojdite v bolnišnico.
In the TRA 2ºP-TIMI 50 trial, although CABG-related TIMI major bleeding was observed in patients taking vorapaxar (see section 4.8), patients who continued therapy with vorapaxar while undergoing CABG did not show an increased risk of major bleeding compared to placebo.
Čeprav so pri bolnikih, ki so prejemali vorapaksar, v preskušanju TRA 2ºP-TIMI 50 opazili s CABG povezane večje krvavitve po TIMI (glejte poglavje 4.8), pri bolnikih, ki so zdravljenje z vorapaksarjem nadaljevali med CABG, niso ugotovili povečanega tveganja za večje krvavitve v primerjavi s placebom.
Patients taking Zontivity should also take acetylsalicylic acid or clopidogrel according to their indications or standard of care.
Bolniki, ki jemljejo zdravilo Zontivity, morajo jemati tudi acetilsalicilno kislino ali klopidogrel v skladu z njunimi indikacijami ali standardno oskrbo.
When administered in addition to standard care, generally acetylsalicylic acid and a thienopyridine, compared with standard care alone, Zontivity increased the risk of GUSTO (Global utilization of streptokinase and tpa for occluded arteries) moderate or severe bleeding (see section 4.8).
Uporabljeno kot dodatek standardni oskrbi, po navadi acetilsalicilni kislini in tienopiridinu, je zdravilo Zontivity v primerjavi s standardno oskrbo samo povečalo tveganje za zmerne ali hude krvavitve po opredelitvi GUSTO (Global utilization of streptokinase and tpa for occluded arteries) (glejte poglavje 4.8).
Adverse reactions were evaluated in 19,632 patients treated with Zontivity [13,186 patients, including 2,187 patients treated for more than 3 years, in the TRA 2°P TIMI 50 (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events) study and 6,446 patients in the TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) study].
Neželene učinke so ocenili pri 19.632 bolnikih, ki so se zdravili z zdravilom Zontivity [v študiji TRA 2°P TIMI 50 (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events) 13.186 bolnikov, vključno z 2.187 bolnikov, zdravljenih več kot 3 leta, in v študiji TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) 6.446 bolnikov].
(See section 5.3.)
(Glejte poglavje 5.3.)
• unexpected bleeding or bleeding that lasts a long time
• nepričakovana ali dolgotrajna krvavitev
Zontivity contains lactose.
Zdravilo Zontivity vsebuje laktozo.
No relevant effects were observed in animals (see section 5.3).
Pri živalih niso opazili nobenih pomembnih učinkov (glejte poglavje 5.3).
The study's primary endpoint was the composite of cardiovascular death, MI, stroke, and UCR.
Primarni opazovani dogodek študije je bil sestavljeni dogodek srčno-žilne smrti, MI, možganske kapi in UCR.
At a dose of 2.5 mg of vorapaxar sulfate (equivalent to 2.08 mg vorapaxar) daily, vorapaxar consistently achieves ≥80% inhibition of TRAP-induced platelet aggregation within one week of initiation of treatment.
V odmerku 2,5 mg vorapaksarjevega sulfata (kar ustreza 2,08 mg vorapaksarja) na dan vorapaksar dosledno doseže ≥ 80 % zaviranje agregacije trombocitov, sprožene s TRAP, v enem tednu po začetku zdravljenja.
Primary Efficacy Endpoint (CV death/MI/stroke/UCR) CV Death
Primarni opazovani dogodek učinkovitosti (CV smrt/MI/ možganska kap/UCR) CV smrt
Minor
Manjše
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z
If you have a stroke, ‘mini-stroke', or bleeding in the brain while taking Zontivity, your doctor ought to stop your Zontivity.
Če imate med jemanjem zdravila Zontivity "mini kap" ali krvavitev v možganih, mora zdravnik prekiniti zdravljenje z zdravilom Zontivity.
(See section 4.4.)
(Glejte poglavje 4.4.)
The clinical evidence for the effect of Zontivity in patients with a history of myocardial infarction, defined as a spontaneous MI ≥2 weeks but 12 months prior, is derived from TRA 2°P - TIMI 50 (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events).
Klinični dokaz učinka zdravila Zontivity pri bolnikih z anamnezo MI, definiranega kot spontani MI ≥ 2 tedna, toda  12 mesecev prej, izhaja iz študije TRA 2°P - TIMI 50 (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events).
Concomitant use of Zontivity with strong inhibitors of CYP3A (e.g., ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan) should be avoided.
Sočasni uporabi zdravila Zontivity in močnih zaviralcev CYP3A (npr. ketokonazola, itrakonazola, posakonazola, klaritromicina, nefazodona, ritonavirja, sakvinavirja, indinavirja, boceprevirja, telaprevirja, telitromicina in konivaptana) se je treba izogibati.
Your doctor may advise stopping Zontivity before surgery.
Zdravnik vam lahko svetuje, da pred operacijo prenehate jemati zdravilo Zontivity.
Among patients with a qualifying MI, Zontivity was initiated at least 2 weeks after the MI and within the first 12 months from the acute event.
Med bolniki z MI, ki je ustrezal kriterijem za vključitev v študijo, so zdravilo Zontivity uvedli vsaj 2 tedna po MI in v prvih 12 mesecih po akutnem dogodku.
In the TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) trial, comprising patients with a NSTEACS (non-ST segment elevation acute coronary syndrome) who were largely antiplatelet naive, vorapaxar, with a loading dose of 40 mg and then maintained at 2.5 mg/day in addition to standard of care, initiated within 24 hours of NSTEACS, did not achieve its primary efficacy endpoint (cardiovascular death, MI, stroke, urgent coronary revascularization, and recurrent ischemia with rehospitalisation) and there was an increased risk of GUSTO moderate or severe bleeding.
V preskušanju TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome), ki je zajemalo bolnike z NSTEACS (non-ST segment elevation acute coronary syndrome), ki v večini še niso bili zdravljeni z antiagregacijskimi zdravili, vorapaksar, uveden v 24 urah po NSTEACS, v polnilnem odmerku 40 mg in vzdrževalnem odmerku 2,5 mg/dan poleg standardne oskrbe, ni dosegel primarnega opazovanega dogodka učinkovitosti (srčno-žilna smrt, MI, možganska kap, nujna koronarna revaskularizacija in ponovna ishemija s ponovnim sprejemom v bolnišnico); poleg tega so ugotovili večje tveganje za zmerne ali hude krvavitve po opredelitvi GUSTO.
In post-MI or PAD patients with no history of stroke or TIA, an analysis of multiple occurrences of adjudicated endpoints indicates that Zontivity was associated with a reduction in the incidence of recurrent events.
Pri bolnikih po MI ali PAD, ki v anamnezi niso imeli možganske kapi ali TIA, je analiza večkratnih pojavov vrednotenih opazovanih dogodkov pokazala, da je bilo zdravilo Zontivity povezano z zmanjšanjem pojavnosti ponovnih dogodkov.
In addition, vorapaxar inhibits thrombin receptor agonist peptide (TRAP)-induced platelet aggregation without affecting coagulation parameters.
Poleg tega vorapaksar zavre s TRAP (trombinski receptorski agonistični peptid) sproženo agregacijo trombocitov, ne da bi vplival na parametre koagulacije.
Co-administration of an aluminium hydroxide/magnesium carbonate antacid or proton pump inhibitor (pantoprazole) did not affect vorapaxar AUC with only small decreases in Cmax.
Sočasna uporaba antacida z aluminijevim hidroksidom/ magnezijevim karbonatom ali zaviralca protonske črpalke (pantoprazola) ni vplivala na AUC vorapaksarja in je le malo zmanjšala Cmax.
Because of the limited therapeutic experience and the increased inherent risk of bleeding in patients with severe hepatic impairment, Zontivity is contraindicated in such patients (see sections 4.3, 4.4, and 5.2).
Zaradi skromnih terapevtskih izkušenj in večjega inherentnega tveganja za krvavitve pri bolnikih s hudo okvaro jeter je zdravilo Zontivity pri teh bolnikih kontraindicirano (glejte poglavja 4.3, 4.4 in 5.2).
It may take at least 7 days for Zontivity to start working.
Da zdravilo Zontivity začne delovati, lahko traja vsaj 7 dni.
(See Table 1.)
(Glejte preglednico 1.)
Steady-state is achieved by 21 days following once-daily dosing.
Stanje dinamičnega ravnovesja je doseženo po 21 dneh uporabe enkrat na dan.
In vitro metabolism studies demonstrate that vorapaxar is unlikely to cause clinically significant inhibition of human CYP1A2, CYP2B6, CYP3A, CYP2C8, CYP2C9, CYP2C19, or CYP2D6.
Glede na študije presnove in vitro ni verjetno, da bi vorapaksar pri človeku povzročil klinično pomembno zaviranje CYP1A2, CYP2B6, CYP3A, CYP2C8, CYP2C9, CYP2C19 ali CYP2D6.
Non-bleeding adverse reactions in Table 1 are summarized for both the TRA 2°P TIMI 50 and TRACER studies.
Neželeni učinki, ki niso krvavitve, v preglednici 1 so povzeti za obe študiji, TRA 2°P TIMI 50 in TRACER.
There is no known treatment to reverse the antiplatelet effect of Zontivity.
Terapija, ki bi odpravila antiagregacijski učinek zdravila Zontivity, ni znana.
If you stop taking Zontivity
Če ste prenehali jemati zdravilo Zontivity
The film-coated tablets are yellow, oval-shaped, size 8.48 mm x 4.76 mm, with “351” on one side and the MSD logo on the other side.
Filmsko obložene tablete so rumene, ovalne, velikosti 8,48 mm x 4,76 mm, z oznako "351" na eni in MSD logotipom na drugi strani.
No clinically meaningful inhibition of CYP2B6, CYP3A, CYP2C19, or CYP2D6 by M20 is expected.
Prav tako ni pričakovati klinično pomembnega zaviranja CYP2B6, CYP3A, CYP2C19 ali CYP2D6 z M20.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).
• preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1
Vorapaxar is highly bound to human serum albumin and does not preferentially distribute into red blood cells.
Vorapaksar je v veliki meri vezan na humani serumski albumin in se ne porazdeli prednostno v eritrocite.
Do not take Zontivity if you are currently being treated with prasugrel or ticagrelor (other anti-platelet agents).
Ne jemljite zdravila Zontivity, če se trenutno zdravite s prasugrelom ali tikagrelorjem (drugi zdravili proti strjevanju krvi).
Consistent with its selective molecular target (PAR-1), vorapaxar has no effect on ADP-induced platelet aggregation in healthy subjects and patient populations.
V skladu s svojo selektivno molekulsko tarčo (PAR-1) vorapaksar, tako pri zdravih osebah kot pri bolnikih, ne vpliva na agregacijo trombocitov, sproženo z ADP.
The mean absolute bioavailability of vorapaxar from the 2.5 mg dose of vorapaxar sulfate is 100%.
Povprečna absolutna biološka uporabnost vorapaksarja iz 2,5-mg odmerka vorapaksarjevega sulfata je 100 %.
• antacids and pantoprazole (used to treat upset stomach)
• antacide in pantoprazol (uporabljajo se za zdravljenje razdraženega želodca),
Vorapaxar exposure (AUC and Cmax) in patients of African descent is estimated to be 17-19% lower compared to that of Caucasians.
Pri bolnikih afriškega porekla je v primerjavi z belci ocenjena izpostavljenost vorapaksarju (AUC in Cmax) od 17 do 19 % manjša.
Hazard Ratio and p-value were calculated based on Andersen-Gill model with covariates treatment and stratification factor (planned thienopyridine use).
Razmerje tveganj in vrednost p sta bila izračunana glede na Andersen-Gill-ov model s sospremenljivkama zdravljenjem in stratifikacijskim faktorjem (načrtovana uporaba tienopiridina).
You and your doctor will decide if you will take Zontivity.
Skupaj z zdravnikom se boste odločili, ali boste jemali zdravilo Zontivity.
No defects were observed in embryo-foetal developmental studies in rats and rabbits at exposures sufficiently in excess of human exposure at the recommended human dose (RHD).
V embrio-fetalnih razvojnih študijah pri podganah in kuncih niso opažali okvar pri izpostavljenostih, ki so dovolj presegale izpostavljenost pri človeku med uporabo priporočenega odmerka za človeka (RHD - recommended human dose).
Pharmacokinetics of vorapaxar are similar between patients with end-stage renal disease (ESRD) undergoing haemodialysis and healthy subjects.
Farmakokinetika vorapaksarja je pri bolnikih s končno odpovedjo ledvic (ESRD - end-stage renal disease), zdravljenih s hemodializo, podobna kot pri zdravih osebah.
• if you have severe liver disease
• če imate hudo bolezen jeter.
Table 5: Multiple Occurrences of Net Clinical Outcome (CV Death/MI/Stroke/GUSTO Severe*) in Post-MI or PAD Patients with No History of Stroke or TIA
Preglednica 5: Večkratni pojavi neto kliničnega izida (CV smrt/MI/možganska kap/GUSTO resni dogodki*) pri bolnikih po MI ali PAD brez anamneze možganske kapi ali TIA
• have active peptic ulcer disease
• če imate aktivno peptično ulkusno bolezen,
• carbamazepine, phenytoin (anti-seizure medicines)
• karbamazepin, fenitoin (antikonvulzivni zdravili),
After oral administration of a single vorapaxar sulfate 2.5 mg dose, vorapaxar is rapidly absorbed and peak concentrations occur at a median tmax of 1 hour (range: 1 to 2) under fasted conditions.
Po peroralni uporabi enkratnega odmerka 2,5 mg vorapaksarjevega sulfata se vorapaksar hitro absorbira in na tešče doseže največjo koncentracijo po medianem tmax 1 uro (razpon: od 1 do 2 uri).
• clarithromycin, telithromycin (used to treat infections)
• klaritromicin, telitromicin (uporabljata se za zdravljenje okužb),
Rates were similar for Zontivity and placebo.
Deleži za zdravilo Zontivity in placebo so bili podobni.
Based upon in vitro data, chronic administration of vorapaxar is unlikely to induce the metabolism of drugs metabolized by major CYP isoforms.
Glede na podatke in vitro ni verjetno, da bi kronična uporaba vorapaksarja inducirala presnovo zdravil, ki se presnavljajo z glavnimi izooblikami CYP.
Co-administration of vorapaxar (40 mg) and digoxin (0.5 mg single-dose) increased digoxin Cmax and AUC by 54% and 5%, respectively.
Sočasna uporaba vorapaksarja (40 mg) in digoksina (enkraten odmerek 0,5 mg) je zvečala Cmax digoksina za 54 % in AUC za 5 %.
• coughing up blood or blood clots
• izkašljevanje krvi ali krvnih strdkov
The adverse reactions in the vorapaxar-treated (n=10,059) and placebo-treated (n=10,049) post-MI or PAD patients with no history of stroke or TIA are shown below.
Spodaj so prikazani neželeni učinki, ki so se pojavili pri z vorapaksarjem (n = 10.059) in s placebom (n = 10.049) zdravljenih bolnikih po MI ali PAD in brez možganske kapi ali TIA v anamnezi.
TIMI Major: Clinically apparent with >50 g/L decrease in haemoglobin or intracranial haemorrhage.
Večje po TIMI: klinično opazna, z znižanjem hemoglobina > 50 g/l ali intrakranialna krvavitev.
• have ever had stomach ulcers or small growths in your gut (‘colon polyps')
• če ste kdaj imeli razjede na želodcu ali drobne izrastke v črevesu ("polipe na debelem črevesu"),
When Zontivity was co-administered with warfarin, there were no alterations in the pharmacokinetics or pharmacodynamics of warfarin.
Če je bilo zdravilo Zontivity uporabljeno sočasno z varfarinom, niso ugotovili sprememb v farmakokinetiki ali farmakodinamiki varfarina.
In repeat dose oral toxicity studies in rodents and monkeys, the principal treatment-related findings were urinary bladder and ureter hyperplasia in mice, hepatic vascular thrombi, lymphoid necrosis and retinal vacuolation in rats and phospholipidosis in all species.
V študijah toksičnosti ponavljajočih se peroralnih odmerkov pri glodalcih in opicah so bile glavne z zdravljenjem povezane spremembe hiperplazija sečnega mehurja in sečevoda pri miših, trombi v jetrnih žilah, limfatična nekroza in vakuolizacija mrežnice pri podganah ter fosfolipidoza pri obeh vrstah.
• itraconazole, ketoconazole, posaconazole (used to treat fungal infections)
• itrakonazol, ketokonazol, posakonazol (uporabljajo se za zdravljenje glivnih okužb),
Patients who experience a stroke, TIA, or ICH while on Zontivity should have therapy discontinued permanently (see sections 4.8 and 5.1).
Bolniki, pri katerih se med uporabo zdravila Zontivity pojavi možganska kap, TIA ali ICH, morajo zdravljenje trajno ukiniti (glejte poglavji 4.8 in 5.1).
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, carcinogenic potential, and fertility.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, genotoksičnosti, kancerogenega potenciala in plodnosti ne kažejo posebnega tveganja za človeka.
- a history of myocardial infarction (MI), co-administered with acetylsalicylic acid (ASA) and,
- z miokardnim infarktom (MI) v anamnezi, v kombinaciji z acetilsalicilno kislino (ASA) in, če
No vorapaxar-related tumours were observed in 2-year rat and mouse studies at oral doses up to 30 mg/kg/day in rats and 15 mg/kg/day in mice (8.9 and 30 times the recommended therapeutic exposures in humans based on plasma exposure to vorapaxar for rats and mice, respectively).
V 2-letnih študijah na podganah in miših pri peroralnih odmerkih do 30 mg/kg/dan pri podganah in do 15 mg/kg/dan pri miših (8,9-kratnik priporočene terapevtske izpostavljenosti človeka na podlagi izpostavljenosti vorapaksarju pri podganah in 30-kratnik pri miših) niso opažali z vorapaksarjem povezanih tumorjev.
• Patients with a history of intracranial haemorrhage (ICH).
• bolniki, ki imajo v anamnezi intrakranialno krvavitev (ICH - intracranial hemorrhage),
Patients with a history of PAD but without a history of stroke or TIA randomized to vorapaxar had fewer peripheral revascularization procedures (15.4% v 19.3%, 3-year KM rates; HR 0.82 [0.71-0.94, 95% CI]; P=0.005) and fewer hospitalizations for acute limb ischemia (2.0% v 3.3%; HR 0.59 [0.400.86]; P=0.007) than patients randomized to placebo.
Bolniki z anamnezo PAD vendar brez anamneze možganske kapi ali TIA, ki so bili randomizirani za zdravljenje z vorapaksarjem, so imeli v primerjavi z bolniki, ki so bili randomizirani za prejemanje placeba, manj posegov periferne revaskularizacije (15,4 % v primerjavi z 19,3 %, 3-letni delež po K-M; HR 0,82 [0,71-0,94, 95 % IZ]; p = 0,005) in manj hospitalizacij zaradi akutne ishemije okončin (2,0 % v primerjavi s 3,3 %; HR 0,59 [0,40 - 0,86]; p = 0,007).
The mean estimated vorapaxar Cmax and AUC were 35% and 33% higher, respectively, in patients with a body weight of <60 kg compared to those weighing 60-100 kg. By comparison, vorapaxar exposure (AUC and Cmax) is estimated to be 19-21% lower in patients with a body weight of >100 kg compared to those weighing 60-100 kg.
Pri bolnikih s telesno maso < 60 kg je bila povprečna ocenjena Cmax vorapaksarja 35 % višja, AUC pa 33 % višja kot pri bolnikih s telesno maso od 60 do 100 kg. Na podlagi primerjave je ocenjeno, da je izpostavljenost vorapaksarju (AUC in Cmax) pri osebah s telesno maso > 100 kg od 19 do 21 % nižja kot pri tistih s telesno maso od 60 do 100 kg. Na splošno je telesna masa < 60 kg dejavnik tveganja za krvavitve.
TIMI Minor: Clinically apparent with 30-50 g/L decrease in haemoglobin.
Manjše po TIMI: klinično opazna z znižanjem hemoglobina za 30-50 g/l.
Patients should be advised to inform physicians and dentists that they are taking Zontivity before any surgery is scheduled and before any new medicinal product is taken.
Bolnikom je treba naročiti, naj pred načrtovanjem kakršne koli operacije in preden vzamejo katero koli novo zdravilo, zdravnikom ali zobozdravnikom povejo, da jemljejo zdravilo Zontivity,.
The results for the bleeding endpoints in the post-MI or PAD patients with no history of stroke or TIA are shown in Table 2.
Rezultati teh opazovanih dogodkov krvavitev pri bolnikih po MI ali PAD, ki v anamnezi niso imeli možganske kapi ali TIA, so prikazani v preglednici 2.