FrancophonIA/ELRC3.0 huggingface dataset:
English: Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15
Croatian: Pseći parainfluenca virus tip 2, soj CPiV-2 Bio 15 10
English: Plastic box containing 25 vials (1 dose) of lyophilisate and 25 vials (1 ml) of solvent.
Croatian: Plastična kutija sadržava 25 bočica (1 doza) liofilizata i 25 bočica (1 ml) otapala.
English: Primary vaccination scheme: Two doses of Versican Plus DHPPi 3-4 weeks apart from 6 weeks of age.
Croatian: Dvije doze cjepiva Versican Plus DHPPi u razmaku od 3 - 4 tjedna nakon navršenih 6 tjedana starosti.
English: Plastic box containing 50 vials (1 dose) of lyophilisate and 50 vials (1 ml) of solvent.
Croatian: Plastična kutija sadržava 50 bočica (1 doza) liofilizata i 50 bočica (1 ml) otapala.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Aqua ad iniectabilia
Croatian: Aqua ad iniectabilia
English: If protection against Leptospira is required, dogs can be vaccinated with two doses of Versican Plus DHPPi mixed with Versican Plus L4 3-4 weeks apart from 6 weeks of age: The contents of a single vial of Versican Plus DHPPi should be reconstituted with the contents of a single vial of Versican Plus L4 (instead of the solvent).
Croatian: Ako je potrebna zaštita od Leptospire, pse se može cijepiti s dvije doze Versican Plus DHPPi pomiješane s Versican Plus L4 s razmakom od 3 - 4 tjedna nakon navršenih 6 tjedana starosti.
English: If protection against Leptospira is required dogs can be vaccinated with two doses of Versican Plus DHPPi mixed with Versican Plus L4 3-4 weeks apart from 6 weeks of age: The contents of a single vial of Versican Plus DHPPi should be reconstituted with the contents of a single vial of Versican Plus L4 (instead of the solvent).
Croatian: Ako je potrebna zaštita od Leptospire pse se može cijepiti s dvije doze Versican Plus DHPPi pomiješane s Versican Plus L4 sa razmakom od 3 - 4 tjedna nakon navršenih 6 tjedana starosti.
English: PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection
Croatian: Liofilizat i otapalo za suspenziju za injekciju
English: MARKETING AUTHORISATION HOLDER
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE U PROMET Zoetis Belgium SA
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Croatian: UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi lyophilisate for dogs
Croatian: Versican Plus DHPPi liofilizat za pse
English: No other adverse reactions other than those mentioned in section 4.6 were observed after administration of a 10-fold overdose of the vaccine.
Croatian: Nakon primjene deseterostruke propisane doze nisu zapažene druge nuspojave osim onih navedenih u odjeljku 6 (Nuspojave).
English: ROUTE(S) OF ADMINISTRATION
Croatian: PUT(EVI) PRIMJENE
English: 103.6 TCID50
Croatian: 6.3 Rok valjanosti
English: STATEMENT OF THE MRLs Not applicable.
Croatian: 4.11 Karencija Nije primjenjivo.
English: 6.1 List of excipients
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari Liofilizat:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi solvent for dogs
Croatian: Versican Plus DHPPi otapalo za pse
English: CLINICAL PARTICULARS
Croatian: Staklene bočice tipa
English: Manufacturer responsible for batch release:
Croatian: Proizvođač odgovoran za puštanje serije u promet: Bioveta, a.s.,
English: − to prevent mortality and clinical signs caused by canine adenovirus type 1,
Croatian: Najmanje tri godine nakon osnovnog cijepljenja protiv virusa štenećaka, psećeg adenovirusa tip 1,
English: Immediate Packaging Pack size
Croatian: Farmaceutski oblik Put primjene Unutarnje pakovanje Veličina pakovanja
English: You should not do both.
Croatian: Ne smijete činiti oboje.
English: Date of first authorisation:19 January 2015
Croatian: Datum prvog odobrenja: 19. siječnja 2015.
English: • are over 75 years of age
Croatian: • ste stariji od 75 godina.
English: DATE OF THE REVISION OF THE TEXT
Croatian: DATUM REVIZIJE TEKSTA
English: The clinical significance of this finding is currently unknown.
Croatian: Klinički značaj ovog nalaza trenutno nije poznat.
English: • sudden difficulty in walking or loss of balance or co-ordination
Croatian: • iznenadne poteškoće pri hodanju ili gubitak ravnoteže ili koordinacije,
English: Your doctor will decide if this medicine is appropriate for you.
Croatian: Vaš će liječnik odlučiti je li ovaj lijek prikladan za Vas.
English: It is especially important to tell your doctor if you take:
Croatian: Osobito je važno je da obavijestite liječnika ako uzimate:
English: If a dose is missed:
Croatian: Ako se propusti doza:
English: Take the medicine pack with you.
Croatian: Ponesite pakiranje lijeka sa sobom.
English: Know the medicines you take.
Croatian: Budite upoznati s lijekovima koje uzimate.
English: Do not take Zontivity if any of the above apply to you.
Croatian: Nemojte uzeti Zontivity ako se nešto od gore navedenoga odnosi na Vas.
English: • sudden numbness or weakness of your arm, leg or face, especially if only on one side of the body
Croatian: • iznenadnu utrnulost ili slabost u ruci, nozi ili na licu, osobito ako je zahvaćena samo jedna strana tijela,
English: It may take at least 7 days for Zontivity to start working.
Croatian: Možda će trebati najmanje 7 dana da Zontivity počne djelovati.
English: • If you forget a dose, take it as soon as you remember.
Croatian: • Ako zaboravite uzeti dozu lijeka, uzmite je čim se sjetite.
English: It is not known if Zontivity will harm your unborn baby.
Croatian: Nije poznato hoće li Zontivity naškoditi Vašem nerođenom djetetu.
English: Total Events
Croatian: Ukupni događaji
English: • Do not take a double-dose (two doses at the same time) to make up for a forgotten dose.
Croatian: • Nemojte uzeti dvostruku dozu (dvije doze odjednom) kako biste nadoknadili zaboravljenu dozu.
English: Zontivity may affect the way other medicines work, and other medicines may affect how Zontivity works.
Croatian: Zontivity može utjecati na način na koji drugi lijekovi djeluju, a i drugi lijekovi mogu utjecati na način na koji Zontivity djeluje.
English: Incidence (%)
Croatian: Incidencija (%)
English: These differences are not considered to be clinically relevant and no dose adjustment is necessary.
Croatian: Te se razlike ne smatraju klinički značajnima i stoga nije potrebno prilagođavati dozu.
English: Your doctor will determine if you should take Zontivity for more than 24 months.
Croatian: Vaš liječnik će odlučiti da li trebate uzimati Zontivity dulje od 24 mjeseca.
English: The mean volume of distribution of vorapaxar is approximately 424 litres.
Croatian: Srednja vrijednost volumena distribucije vorapaksara iznosi približno 424 litre.
English: Hazard Ratio (95% CI)
Croatian: Omjer rizika (95% CI)
English: If Zontivity must be temporarily discontinued, restart it as soon as possible.
Croatian: Ako se primjena lijeka Zontivity mora privremeno prekinuti, ponovno je započnite što je prije moguće.
English: The recommended dose is one tablet by mouth each day taken with or without food.
Croatian: Preporučena doza je jedna tableta kroz usta svaki dan, a može se uzimati s hranom ili bez nje.
English: Do not take Zontivity:
Croatian: Nemojte uzimati Zontivity:
English: Patients with low body weight (<60 kg)
Croatian: Bolesnici niske tjelesne težine (<60 kg)
English: • sudden confusion, difficulty speaking,or understanding others
Croatian: • iznenadnu smetenost, otežan govor ili otežano razumijevanje drugih osoba,
English: The most common adverse reaction reported during treatment is bleeding.
Croatian: Najčešća nuspojava prijavljena tijekom liječenja je krvarenje.
English: Specific populations
Croatian: Posebne populacije
English: • Take Zontivity on a regular basis and for as long as your doctor keeps prescribing it.
Croatian: • Zontivity uzimajte redovito i sve dok Vam ga liječnik propisuje.
English: Zontivity is used to lower your chance of:
Croatian: Zontivity se koristi kako bi se smanjila vjerojatnost:
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, carcinogenic potential, and fertility.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, genotoksičnosti, kancerogenosti i plodnosti.
English: • needing an urgent operation to open blocked arteries in the heart.
Croatian: • potrebe za hitnom operacijom kojom bi se otvorile začepljene arterije u srcu.
English: Ask your doctor or pharmacist if you are not sure if your medicine is listed above.
Croatian: Pitajte svog liječnika ili ljekarnika ako niste sigurni je li Vaš lijek naveden na gornjem popisu.
English: Zontivity is used in adults who have had a heart attack or have a condition known as "peripheral arterial disease" (also known as poor circulation in the legs).
Croatian: Zontivity se koristi u odraslih osoba koje su imale srčani udar ili imaju bolest koja se zove "bolest perifernih arterija" (također poznata i kao slaba cirkulacija u nogama).
English: The median Body Mass Index was 28.
Croatian: Medijan indeksa tjelesne mase iznosio je 28.
English: • pink, red, or brown urine
Croatian: • ružičastu, crvenu ili smeđu boju mokraće,
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i svim sljedećim nadopunama objavljenima na europskom internetskom portalu za lijekove.
English: Other medicines and Zontivity
Croatian: Drugi lijekovi i Zontivity
English: In general, a body weight <60 kg is a risk factor for bleeding.
Croatian: Općenito je tjelesna težina <60 kg faktor rizika za krvarenje.
English: The duration of these pharmacodynamic effects is consistent with the drug's elimination half-life.
Croatian: Trajanje tih farmakodinamičkih učinaka u skladu je s poluvijekom eliminacije lijeka.
English: BLISTER - unit dose
Croatian: BLISTER - djeljiv na jedinične doze
English: This is because it is not known if Zontivity is safe and works in children and adolescents.
Croatian: Naime, nije poznato je li Zontivity siguran i djelotvoran u djece i adolescenata.
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: Učestalost je definirana kako slijedi: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti na temelju dostupnih podataka).
English: • Patients with any active pathological bleeding (see sections 4.4 and 4.8).
Croatian: • Bolesnici s bilo kojim aktivnim patološkim krvarenjem (vidjeti dijelove 4.4 i 4.8).
English: • suddenly feeling dizzy or sudden severe headache with no known cause
Croatian: • iznenadnu omaglicu ili iznenadnu jaku glavobolju bez poznatog uzroka.
English: The median Body Mass Index was 27.
Croatian: Medijan indeksa tjelesne mase iznosio je 27.
English: The median duration of treatment with vorapaxar was 823 days (interquartile range: 645-1016 days).
Croatian: Medijan trajanja liječenja vorapaksarom iznosio je 823 dana (interkvartilni raspon: 645-1016 dana).
English: Treatment of presumed overdose should address signs and symptoms.
Croatian: Liječenje u slučaju pretpostavljenoga predoziranja mora se usredotočiti na znakove i simptome.
English: Zontivity should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the foetus.
Croatian: Zontivity se tijekom trudnoće smije uzimati samo ako moguća korist liječenja za majku opravdava mogući rizik za plod.
English: Severe bleeding is uncommon, but can be life threatening.
Croatian: Teško krvarenje je manje često, ali može biti opasno po život.
English: Table 3: CABG-Related Bleeds
Croatian: Tablica 3: Krvarenja vezana uz CABG
English: Patients with only one Event Patients with two Events Patients with ≥3 Events
Croatian: Bolesnici sa samo jednim događajem Bolesnici sa dva događaja Bolesnici s ≥3 događaja
English: There is less information about other types of surgery but the overall evidence does not suggest an excessive risk of major bleeding.
Croatian: O drugim vrstama kirurških zahvata dostupno je manje informacija, ali sveukupni dokazi ne ukazuju na prekomjeran rizik od obilnog krvarenja.
English: Pharmacokinetics of vorapaxar are similar between elderly, including those ≥75 years of age, and younger patients.
Croatian: Farmakokinetika vorapaksara slična je među starijim osobama, uključujući one u dobi od ≥75 godina, i mlađim bolesnicima.
English: • rifampin (used to treat tuberculosis and some other infections)
Croatian: • rifampin (koristi se za liječenje tuberkuloze i nekih drugih infekcija),
English: There are no reliable data on the use of vorapaxar in pregnant women.
Croatian: Nema pouzdanih podataka o primjeni vorapaksara u trudnica.
English: Any unused medicinal product or material should be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek ili materijal valja zbrinuti sukladno lokalnim propisima.
English: Zontivity may be taken with or without food.
Croatian: Zontivity se može uzimati s hranom ili bez nje.
English: You may be at increased risk of bleeding.
Croatian: Može postojati povećan rizik od krvarenja.
English: The safety and efficacy of Zontivity in children aged less than 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Zontivity u djece mlađe od 18 godina nisu još ustanovljene.
English: • if you have unusual bleeding now, such as bleeding in your brain, stomach or gut
Croatian: • ako sada imate neuobičajeno krvarenje, poput krvarenja u mozgu, želucu ili crijevima,
English: Tél: + 33 (0) 1 80 46 40 40
Croatian: MSD France Tél: 33 (0) 1 80 46 40 40
English: * K-M estimate at 1,080 days
Croatian: K-M procjena nakon 1080 dana.
English: Among the common bleeding events, epistaxis is the most frequent.
Croatian: Među čestim događajima krvarenja, najčešća je epistaksa.
English: The duration of platelet inhibition is dose and concentration dependent.
Croatian: Trajanje inhibicije trombocita ovisi o dozi i koncentraciji.
English: However, if it is within 12 hours of the next dose, skip the missed dose.
Croatian: Međutim, ako je do sljedeće doze preostalo 12 sati ili manje, preskočite propuštenu dozu.
English: Patients with events (%)
Croatian: Bolesnici s događajima (%)
English: What you need to know before you take Zontivity
Croatian: Što morate znati prije nego počnete uzimati Zontivity
English: The apparent terminal half-life for vorapaxar is 187 hours (range 115-317 hours) and is similar for the active metabolite.
Croatian: Prividni terminalni poluvijek vorapaksara iznosi 187 sati (raspon: 115-317 sati), a sličan je i kod aktivnog metabolita.
English: Keep a list of them to show your doctor and pharmacist when you get a new medicine.
Croatian: Vodite popis tih lijekova kako biste ga mogli pokazati svom liječniku ili ljekarniku kad dobijete novi lijek.
English: Zontivity is indicated for the reduction of atherothrombotic events in adult patients with
Croatian: Zontivity je indiciran za smanjenje aterotrombotskih događaja u odraslih bolesnika s
English: Randomization to 18 months
Croatian: Randomizirano do 18 mjeseci
English: This reduces the chance of a blood clot forming and blocking the arteries, such as the arteries in the heart.
Croatian: Na taj način smanjuje se vjerojatnost stvaranja krvnog ugruška i začepljenja arterija, kao na primjer arterija u srcu.
English: • bleeding from cuts or wounds that is more than normal
Croatian: • krvarenje iz posjekotina ili rana koje je obilnije od normalnoga,
English: • red or black stools (looks like tar)
Croatian: • crvenu ili crnu stolicu (koja nalikuje katranu),
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Zontivity in one or more subsets of the paediatric population in prevention of arterial thromboembolism (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka Zontivity u jednoj ili više podskupina pedijatrijske populacije u prevenciji arterijske tromboembolije (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Vorapaxar is highly bound to human serum albumin and does not preferentially distribute into red blood cells.
Croatian: Vorapaksar se u velikoj mjeri vezuje za humani serumski albumin te se ne raspodjeljuje preferencijalno u crvene krvne stanice.
English: Studies in rats have shown vorapaxar and/or its metabolites are excreted in milk.
Croatian: Ispitivanja na štakorima pokazala su da se vorapaksar i/ili njegovi metaboliti izlučuju u mlijeko.
English: If you take more Zontivity than you should
Croatian: Ako uzmete više lijeka Zontivity nego što ste trebali
English: Zontivity is not recommended for children and adolescents under 18 years of age.
Croatian: Ne preporučuje se primjena lijeka Zontivity u djece i adolescenata mlađih od 18 godina.
English: BE-2220 Heist-op-den-Berg Belgium
Croatian: BE-2220 Heist-op-den-Berg Belgija
English: • if you have had bleeding in the brain
Croatian: • ako ste ikada imali krvarenje u mozgu,
English: Rates were similar for Zontivity and placebo.
Croatian: Stope su bile slične i za Zontivity i za placebo.
English: • have had any recent serious injury or surgery
Croatian: • ste nedavno pretrpjeli ozbiljnu ozljedu ili ste imali kirurški zahvat,
English: Bleeding category definitions:
Croatian: Definicije kategorija krvarenja:
English: • if you are allergic to vorapaxar sulfate or any of the other ingredients of this medicine (listed in section 6)
Croatian: • ako ste alergični na vorapaksarsulfat ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.),
English: Follow your doctor's instructions about stopping Zontivity.
Croatian: Slijedite upute svoga liječnika o tome kako prekinuti liječenje lijekom Zontivity.
English: What Zontivity is and what it is used for
Croatian: Što je Zontivity i za što se koristi
English: Platelets are blood cells that help with normal blood clotting.
Croatian: Krvne pločice (trombociti) su krvne stanice koje pomažu pri normalnom zgrušavanju krvi.
English: Call your doctor straight away, if you have any of these signs or symptoms of bleeding while taking Zontivity:
Croatian: Odmah se obratite svom liječniku ako primijetite bilo koji od sljedećih znakova ili simptoma krvarenja dok uzimate Zontivity:
English: • bleeding in your eye
Croatian: • krvarenje u oku,
English: • have a bodyweight of less than 60 kg
Croatian: • imate tjelesnu težinu nižu od 60 kg,
English: 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
Croatian: Filmom obložena tableta 7 filmom obloženih tableta 10 x 1 filmom obložena tableta 28 filmom obloženih tableta 30 filmom obloženih tableta 50 x 1 filmom obložena tableta 100 filmom obloženih tableta
English: • The active substance is vorapaxar sulfate.
Croatian: • Djelatna tvar je vorapaksarsulfat.
English: Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom
Croatian: Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon Hertfordshire EN11 9BU Ujedinjeno Kraljevstvo
English: Therefore, Zontivity should be used with caution in such patients.
Croatian: Stoga Zontivity treba primjenjivati uz oprez u tih bolesnika.
English: Bleeding events were treated in the same manner as for other antiplatelet agents including addressing the source of bleeding while providing supportive care.
Croatian: Događaji krvarenja zbrinjavali su se na isti način kao i kod drugih antitrombocitnih lijekova, uključujući uklanjanje izvora krvarenja uz istodobno potporno liječenje.
English: Tell all of your doctors and dentists that you are taking Zontivity.
Croatian: Obavijestite sve svoje liječnike i stomatologe da uzimate Zontivity.
English: 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.
Croatian: Bolesnik koji propusti dozu lijeka Zontivity mora preskočiti propuštenu dozu ako je do sljedeće predviđene doze preostalo 12 sati ili manje te uzeti sljedeću dozu prema uobičajenom rasporedu.
English: Your doctor will determine if you should also take aspirin, clopidogrel, or both, while taking Zontivity.
Croatian: Vaš liječnik će odlučiti trebate li također uzimati aspirin, klopidogrel ili oboje tijekom liječenja lijekom Zontivity.
English: Patients receiving digoxin should be monitored as clinically indicated.
Croatian: Bolesnike koji uzimaju digoksin treba nadzirati sukladno kliničkoj potrebi.
English: Interruption of Zontivity treatment should be avoided.
Croatian: Treba izbjegavati prekidanje liječenja lijekom Zontivity.
English: The recommended dose of Zontivity is 2.08 mg to be taken once daily.
Croatian: Preporučena doza lijeka Zontivity je 2,08 mg, a uzima se jedanput na dan.
English: No dosage adjustment of digoxin or Zontivity is recommended.
Croatian: Ne preporučuje se prilagođavati dozu digoksina ni lijeka Zontivity.
English: The effect of Zontivity on GUSTO severe or moderate bleeding relative to placebo was shown to be consistent across the subgroups examined.
Croatian: Učinak lijeka Zontivity na teško ili umjereno krvarenje prema GUSTO kriterijima u odnosu na placebo pokazao se dosljednim u svim ispitivanim podskupinama.
English: Vorapaxar is eliminated primarily by metabolism, with significant contribution by CYP3A.
Croatian: Vorapaksar se prvenstveno eliminira metabolizmom, kojemu značajno pridonosi CYP3A.
English: Uncommon: may affect up to 1 in 100 people
Croatian: Manje česte: javljaju se u do 1 na 100 osoba
English: • have had bleeding problems in the past
Croatian: • ste imali tegoba s krvarenjem u prošlosti,
English: Continued therapy after this time must be based on a re-evaluation of the benefits and risks for the individual of further therapy.
Croatian: Nastavak liječenja nakon tog perioda mora se temeljiti na ponovnoj procijeni koristi i rizika daljnjeg liječenja za svakog pojedinog bolesnika.
English: The effect of vorapaxar on the QTc interval was evaluated in a thorough QT study and in other studies.
Croatian: Učinak vorapaksara na QTc interval ocijenjen je u temeljitom ispitivanju QT intervala i drugim ispitivanjima.
English: 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.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku, ljekarniku ili medicinskoj sestri za savjet prije nego uzmete ovaj lijek.
English: Zontivity contains an active substance called vorapaxar, and it belongs to a group of medicines called ‘anti-platelet medicines.'
Croatian: Zontivity sadrži djelatnu tvar koja se zove vorapaksar, a pripada skupini lijekova koji se nazivaju antitrombocitni lijekovi.
English: 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.
Croatian: Općeniti faktori rizika za krvarenje uključuju stariju dob (međutim, nije potrebno prilagođavati dozu u starijih osoba, vidjeti dio 5.2)), nisku tjelesnu težinu te smanjenu funkciju bubrega ili jetre.
English: Vorapaxar is also a substrate of CYP2J2; therefore, there is a potential for potent inhibitors of CYP2J2 to result in increases in vorapaxar exposure.
Croatian: Osim toga, vorapaksar je i supstrat za CYP2J2; stoga postoji mogućnost da potentni inhibitori CYP2J2 povećaju izloženost vorapaksaru.