FrancophonIA/ELRC3.0 huggingface dataset:
English: You should tell your doctor immediately if you develop a medical condition called Thrombotic Thrombocytopaenic Purpura (or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects').
Croatian: Morate odmah obavijestiti liječnika ako se razvije bolest koja se zove trombotična trombocitopenična purpura (TTP), a koja uključuje vrućicu i nastajanje potkožnih modrica koje se mogu pojaviti kao okrugle, crvene točkice veličine vrška pribadače, a mogu je, ali ne moraju, pratiti neobjašnjiv izrazit umor, smetenost, žutilo kože ili očiju (žutica) (vidjeti dio 4 'Moguće nuspojave').
English: If you have been told by a doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, savjetujte se s liječnikom prije uzimanja ovog lijeka.
English: In patients with or without a history of TIA or stroke, the incidence of stroke in the phase 3 clinical trial was as follows (see section 4.4):
Croatian: U bolesnika koji imaju odnosno nemaju TIA-u ili moždani udar u anamnezi, incidencija moždanog udara u fazi III kliničkog ispitivanja bila je kako slijedi (vidjeti dio 4.4):
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take Efient.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom Lapp laktaze ili malapsorpcijom glukoze i galaktoze ne bi trebali uzimati Efient.
English: Efient 5 mg: 2 years.
Croatian: Efient 5 mg: 2 godine.
English: In these patients the 10 mg maintenance dose is not recommended.
Croatian: U tih se bolesnika ne preporučuje doza održavanja od 10 mg.
English: Administration of the 60 mg prasugrel loading dose in the fasted state may provide most rapid onset of action (see section 5.2).
Croatian: Primjena udarne doze od 60 mg prasugrela natašte može omogućiti najbrži početak djelovanja (vidjeti dio 5.2).
English: Medicinal products metabolised by CYP2B6:
Croatian: Lijekovi koji se metaboliziraju putem CYP2B6:
English: Prasugrel has no clinically significant effect on the pharmacokinetics of digoxin.
Croatian: Prasugrel nema klinički značajan učinak na farmakokinetiku digoksina.
English: If you forget to take Efient
Croatian: Ako ste zaboravili uzeti Efient
English: Animal studies have shown excretion of prasugrel in breast milk.
Croatian: Ispitivanja na životinjama pokazala su da se prasugrel izlučuje u mlijeko.
English: Approximately 40% of patients (in each of the treatment groups) received GPIIb/IIIa inhibitors in support of PCI (no information available regarding the type of GP IIb/IIIa inhibitor used).
Croatian: Približno 40% bolesnika (u svakoj od liječenih skupina) primalo je inhibitore GPIIb/IIIa kao potporu PCI-u (nema podataka o vrsti primijenjenih GPIIb/IIIa inhibitora).
English: Other therapies, such as heparin and GPIIb/IIIa inhibitors, were administered at the discretion of the physician.
Croatian: Drugi lijekovi poput heparina ili inhibitora GPIIb/IIIa primjenjivani su u skladu s procjenom liječnika.
English: Eli Lilly Polska Sp. z o.o.
Croatian: Eli Lilly Polska Sp. z o.o. Tel.
English: Patients weighing < 60 kg
Croatian: Bolesnici tjelesne težine < 60 kg
English: The benefits associated with prasugrel were independent of the use of other acute and long-term cardiovascular therapies, including heparin/low molecular weight heparin, bivalirudin, intravenous GPIIb/IIIa inhibitors, lipid-lowering medicinal products, beta-blockers, and angiotensin converting enzyme inhibitors.
Croatian: Korist od primjene prasugrela bila je neovisna o akutnoj ili dugoročnoj primjeni drugih lijekova za liječenje bolesti srca i krvnih žila, uključujući heparin ili heparin male molekulske težine, bivalirudin, intravensku primjenu inhibitora GPIIb/IIIa, lijekove za snižavanje lipida, blokatore beta adrenergičkih receptora i inhibitore angiotenzin konvertirajućeg enzima.
English: In a study of healthy subjects, AUC of the active metabolite was unaffected by a high fat, high calorie meal, but Cmax was decreased by 49% and the time to reach Cmax (Tmax) was increased from 0.5 to 1.5 hours.
Croatian: U ispitivanju zdravih ispitanika punomastan, visoko kaloričan obrok nije utjecao na AUC aktivnog metabolita, ali je njegov Cmax smanjen za 49%, a vrijeme do nastupa Cmax (tmax) produljeno s 0,5 na 1,5 sati.
English: In a study of healthy subjects between the ages of 20 and 80 years, age had no significant effect on pharmacokinetics of prasugrel or its inhibition of platelet aggregation.
Croatian: U ispitivanju zdravih ispitanika u dobi između 20 i 80 godina dob nije značajno utjecala na farmakokinetiku prasugrela ni njegovu inhibiciju agregacije trombocita.
English: Each tablet contains 2.7 mg lactose.
Croatian: Jedna tableta sadrži 2,7 mg laktoze.
English: Do not use this medicine after the expiry date, which is stated on the blister and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake EXP/Rok valjanosti.
English: Hypersensitivity reactions including angioedema have been reported in patients receiving prasugrel, including in patients with a history of hypersensitivity reaction to clopidogrel.
Croatian: Reakcije preosjetljivosti, uključujući angioedem, prijavljene su u bolesnika koji su primali prasugrel, uključujući i bolesnike koji su ranije imali reakciju preosjetljivosti na klopidogrel.
English: The phase 3 TRITON study compared Efient (prasugrel) with clopidogrel, both co-administered with ASA and other standard therapy.
Croatian: U fazi III ispitivanja pod nazivom TRITON uspoređivao se Efient (prasugrel) s klopidogrelom, pri čemu su se oba primjenjivala istodobno s ASK-om i drugim standardnim lijekovima.
English: Efient can also be concomitantly administered with ASA, heparin, digoxin, and medicinal products that elevate gastric pH, including proton pump inhibitors and H2 blockers.
Croatian: Efient se također može primjenjivati istodobno s ASK-om, heparinom, digoksinom i lijekovima koji povisuju želučani pH, uključujući i inhibitore protonske pumpe i blokatore H2-receptora.
English: What Efient contains - The active substance is prasugrel.
Croatian: Što Efient sadrži - Djelatna tvar je prasugrel.
English: There was an increased incidence of tumours (hepatocellular adenomas) in mice exposed for 2 years to high doses (> 75 times human exposure), but this was considered secondary to prasugrel-induced enzyme-induction.
Croatian: (hepatocelularnih adenoma) bila je povećana u miševa koji su dvije godine bili izloženi visokim dozama (> 75 puta veća izloženost nego u ljudi), ali se to smatralo posljedicom enzimske indukcije izazvane prasugrelom.
English: If clots form within a hardened blood vessel such as an artery they can be very dangerous as they can cut off the blood supply, causing a heart attack (myocardial infarction), stroke or death.
Croatian: Stvore li se ugrušci unutar otvrdnute krvne žile, primjerice u arteriji, oni mogu biti vrlo opasni jer mogu prekinuti opskrbu krvlju i tako prouzročiti srčani udar (infarkt miokarda), moždani udar ili smrt.
English: Clopidogrel 75 mg
Croatian: Klopidogrel 75 mg
English: No significant difference was seen in the STEMI population.
Croatian: Međutim, u populaciji bolesnika koji su imali STEMI nije zabilježena značajna razlika.
English: Therefore, the use of Efient in patients at increased risk of bleeding should only be considered when the benefits in terms of prevention of ischaemic events are deemed to outweigh the risk of serious bleedings.
Croatian: Stoga se primjena lijeka Efient u bolesnika s povećanim rizikom od krvarenja smije razmotriti samo onda kada se procijeni da dobrobit u smislu prevencije ishemijskih događaja nadilazi rizik od ozbiljnih krvarenja.
English: Each tablet contains 2.1 mg lactose.
Croatian: Jedna tableta sadrži 2,1 mg laktoze.
English: Prasugrel is expected to have no or negligible influence on the ability to drive and use machines.
Croatian: Očekuje se da prasugrel ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: In the phase 3 clinical trial, Efient was administered without regard to co-administration of a proton pump inhibitor or H2 blocker.
Croatian: U fazi III kliničkog ispitivanja Efient se primjenjivao bez obzira na istodobnu primjenu inhibitora protonske pumpe ili blokatora H2-receptora.
English: When a blood vessel is damaged, for example if it is cut, platelets clump together to help form a blood clot (thrombus).
Croatian: Kad dođe do oštećenja krvne žile, primjerice ako se porežete, trombociti se nakupljaju i pomažu da se stvori krvni ugrušak (tromb).
English: Efient inhibits the clumping of platelets and so reduces the chance of a blood clot forming.
Croatian: Efient sprečava nakupljanje trombocita te tako smanjuje vjerojatnost nastanka krvnog ugruška.
English: +ASA (N = 5001)
Croatian: +ASK (N = 5001)
English: Morphine and other opioids:
Croatian: Morfin i drugi opioidi:
English: Non-CABG- related TIMI bleeding rates through 7 days for patients were as follows:
Croatian: Stope krvarenja nevezanog za CABG prema TIMI kriterijima tijekom 7 dana bile su kako slijedi:
English: Administration of the 60 mg prasugrel loading dose without concomitant use of proton pump inhibitors may provide most rapid onset of action.
Croatian: Primjenom udarne doze prasugrela od 60 mg bez istodobne primjene inhibitora protonske pumpe može se postići najbrži početak djelovanja.
English: • Bleeding in the stomach or bowels
Croatian: • krvarenje u želucu ili crijevima
English: Morphine and other opioids
Croatian: Morfin i drugi opioidi
English: Prasugrel's pharmacokinetics are similar in healthy subjects, patients with stable atherosclerosis, and patients undergoing percutaneous coronary intervention.
Croatian: Farmakokinetika prasugrela podjednaka je u zdravih ispitanika, bolesnika sa stabilnom aterosklerozom i bolesnika podvrgnutih perkutanoj koronarnoj intervenciji.
English: Effects of other medicinal products on Efient
Croatian: Učinci lijeka Efient na druge lijekove
English: Event
Croatian: Događaj
English: The benefits and risks of prasugrel should be carefully considered in patients in whom the coronary anatomy has not been defined and urgent CABG is a possibility.
Croatian: Potrebno je pažljivo procijeniti koristi i rizike liječenja prasugrelom u bolesnika u kojih nije poznata anatomija koronarnog krvožilja, a u kojih postoji mogućnost za hitan CABG.
English: Concomitant administration of Efient with coumarin derivatives other than warfarin has not been studied.
Croatian: Nije ispitivana istodobna primjena lijeka Efient s derivatima kumarina osim varfarina.
English: For patients with active bleeding for whom reversal of the pharmacological effects of Efient is required, platelet transfusion may be appropriate.
Croatian: U bolesnika s aktivnim krvarenjem u kojih je potrebno antagonizirati farmakološke učinke lijeka Efient možda će biti primjerena transfuzija trombocita.
English: 4.4 Special warnings and precautions for use
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Rizik od krvarenja
English: d Life-threatening bleeding is a subset of TIMI major bleeding and includes the types indented below.
Croatian: d Životno ugrožavajuće krvarenje je podskupina značajnih krvarenja prema TIMI kriterijima i uključuje oblike krvarenja navedene ispod.
English: Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4 and CYP3A5, did not affect prasugrel-mediated inhibition of platelet aggregation or the prasugrel active metabolite's AUC and Tmax, but decreased the Cmax by 34% to 46%.
Croatian: Ketokonazol (400 mg na dan), selektivan i snažan inhibitor CYP3A4 i CYP3A5, nije utjecao na prasugrelom posredovanu inhibiciju agregacije trombocita niti na AUC i tmax aktivnog metabolita prasugrela, ali je smanjio njegov Cmax za 34% do 46%.
English: ≥75 years (N=1785)*
Croatian: ≥ 75 godina (N=1785)*
English: In pre- and post-natal rat studies, maternal treatment had no effect on the behavioural or reproductive development of the offspring at doses up to an exposure 240 times the recommended daily human maintenance dose (based on mg/m2).
Croatian: U istraživanjima prenatalnog i postnatalnog razvoja na štakorima, davanje lijeka majci nije imalo učinka na razvoj ponašanja niti na reproduktivni razvoj potomaka pri dozama koje su dovele do 240 puta veće izloženosti od one koja se postiže u ljudi kod primjene preporučene dnevne doze održavanja (na temelju mg/m2).
English: Acute Coronary Syndrome (ACS)
Croatian: Klinička djelotvornost i sigurnost Akutni koronarni sindrom (ACS)
English: The 10 mg maintenance dose is not recommended.
Croatian: Ne preporučuje se doza održavanja od 10 mg.
English: Analysis of the composite endpoint in the All ACS population (combined UA/NSTEMI and STEMI cohorts) was contingent on showing statistical superiority of prasugrel versus clopidogrel in the UA/NSTEMI cohort (p < 0.05).
Croatian: Analiza objedinjenog ishoda u populaciji svih bolesnika s akutnim koronarnim sindromom (združene UA/NSTEMI i STEMI kohorte) ovisila je o dokazivanju statističke superiornosti prasugrela u odnosu na klopidogrel u kohorti bolesnika koji su imali UA/NSTEMI (p < 0,05).
English: Distribution Active metabolite binding to human serum albumin (4% buffered solution) was 98%.
Croatian: Distribucija Aktivni metabolit se vezuje za humani serumski albumin (u puferiranoj otopini od 4%) u omjeru od
English: Prasugrel is a weak inhibitor of CYP2B6.
Croatian: Prasugrel je slab inhibitor CYP2B6.
English: Limited data are available in children with sickle cell anaemia (see section 5.1).
Croatian: Dostupni su ograničeni podaci o primjeni u djece s anemijom srpastih stanica (vidjeti dio 5.1).
English: Therefore, known CYP3A inducers such as rifampicin, carbamazepine, and other inducers of cytochromes P450 are not anticipated to have significant effect on the pharmacokinetics of the active metabolite.
Croatian: Stoga se ne predviđa da bi poznati induktori CYP3A poput rifampicina, karbamazepina te drugi induktori citokroma P450 imali značajan učinak na farmakokinetiku aktivnog metabolita.
English: Prasugrel is a prodrug and is rapidly metabolised in vivo to an active metabolite and inactive metabolites.
Croatian: Prasugrel je predlijek i brzo se metabolizira in vivo u jedan aktivni i više neaktivnih metabolita.
English: In the All ACS population, prasugrel was associated with a lower incidence of CV death, non-fatal MI, or non-fatal stroke compared to clopidogrel, regardless of baseline characteristics such as age, sex, body weight, geographical region, use of GPIIb/IIIa inhibitors, and stent type.
Croatian: U populaciji svih bolesnika s ACS-om primjena prasugrela je u usporedbi s primjenom klopidogrela bila povezana s nižom incidencijom smrti zbog KV uzroka, nesmrtonosnog IM odnosno nesmrtonosnog moždanog udara, bez obzira na početne karakteristike poput dobi, spola, tjelesne težine, geografske regije, primjene inhibitora GPIIb/IIIa ili vrstu stenta.
English: Study TADO tested the use of prasugrel (n=171) vs placebo (n=170) in patients, ages 2 to less than 18 years of age, with sickle cell anaemia for reduction of vaso occlusive crisis in a phase III study.
Croatian: Ispitivanje TADO bilo je ispitivanje faze III u kojem se ispitivala primjena prasugrela (n=171) naspram placeba (n=170) za smanjenje vazookluzivne krize u bolesnika s anemijom srpastih stanica u dobi od 2 do manje od 18 godina.
English: In healthy subjects, prasugrel decreased exposure to hydroxybupropion, a CYP2B6-mediated metabolite of bupropion, by 23%.
Croatian: U zdravih je ispitanika prasugrel za 23% smanjio izloženost hidroksibupropionu, metabolitu bupropiona koji se metabolizira putem CYP2B6.
English: and 4.8).
Croatian: (vidjeti dio 4.8).
English: How to take Efient
Croatian: Kako uzimati Efient
English: The use of Efient in patients ≥75 years of age is generally not recommended and should only be undertaken with caution after a careful individual benefit/risk evaluation by the prescribing physician indicates that benefits in terms of prevention of ischaemic events outweigh the risk of serious bleedings.
Croatian: Primjena lijeka Efient u bolesnika u dobi od ≥ 75 godina općenito se ne preporučuje i smije se provoditi uz oprez tek nakon što liječnik propisivač pažljivo procijeni korist i rizik u pojedinog bolesnika i zaključi da dobrobit u smislu prevencije ishemijskih događaja nadilazi rizik od ozbiljnih krvarenja.
English: TIMI minor bleeding f
Croatian: Manje krvarenje prema TIMI f
English: History of stroke or transient ischaemic attack (TIA).
Croatian: Moždani udar ili tranzitorna ishemijska ataka (TIA) u anamnezi.
English: Therefore, Efient can be administered without regard to food; however, the administration of prasugrel loading dose in the fasted state may provide most rapid onset of action (see section 4.2).
Croatian: Stoga se Efient može davati neovisno o obroku, no primjena udarne doze prasugrela natašte može omogućiti najbrži nastup djelovanja (vidjeti dio 4.2).
English: Prasugrel + ASA
Croatian: Prasugrel + ASK
English: Although uncommon, severe bleeding can be life-threatening.
Croatian: Iako se događa manje često, jako krvarenje može ugrožavati život.
English: Although bleeding was increased with prasugrel, an analysis of the composite endpoint of death from any cause, nonfatal myocardial infarction, nonfatal stroke, and non-CABG-related TIMI major haemorrhage favoured Efient compared to clopidogrel (Hazard ratio, 0.87; 95% CI, 0.79 to 0.95; p = 0.004).
Croatian: Iako je broj krvarenja bio povećan uz primjenu prasugrela, rezultati analize objedinjenih ishoda koji su uključivali smrt zbog bilo kojeg uzroka, nesmrtonosni infarkt miokarda, nesmrtonosni moždani udar i značajno krvarenje (prema TIMI) nevezano uz CABG govorili su u prilog lijeka Efient u usporedbi s klopidogrelom (HR: 0,87; 95% CI: 0,79 do 0,95; p = 0,004).
English: These included definite or probable stent thrombosis at study end (0.9% vs 1.8%; HR 0.498; CI 0.364, 0.683); CV death, nonfatal MI, or urgent target vessel revascularisation through 30 days (5.9% vs 7.4%; HR 0.784; CI 0.688,0.894); all cause death, nonfatal MI, or nonfatal stroke through study end (10.2% vs 12.1%; HR 0.831; CI 0.751, 0.919); CV death, nonfatal MI, nonfatal stroke or rehospitalisation for cardiac ischaemic event through study end (11.7% vs 13.8%; HR 0.838; CI 0.762, 0.921).
Croatian: Hazard Ratio, HR): 0,498; CI: 0,364; 0,683); smrt zbog KV uzroka, nesmrtonosni IM ili hitna revaskularizacija ciljne krvne žile do 30. dana (5,9% u odnosu na 7,4%; HR: 0,784; CI: 0,688; 0,894); smrt zbog bilo kojeg uzroka, nesmrtonosni infarkt miokarda ili nesmrtonosni moždani udar do završetka ispitivanja (10,2% u odnosu na 12,1%; HR: 0,831; CI: 0,751; 0,919); smrt zbog KV uzroka, nesmrtonosni IM, nesmrtonosni moždani udar ili ponovna hospitalizacija zbog srčanog ishemijskog događaja do završetka ispitivanja (11,7% u odnosu na
English: Patients ≥ 75 years of age have greater sensitivity to bleeding and higher exposure to the active metabolite of prasugrel (see sections 4.4, 4.8, 5.1 and 5.2).
Croatian: Bolesnici u dobi od ≥ 75 godina skloniji su krvarenju i izloženi su većoj koncentraciji aktivnog metabolita prasugrela (vidjeti dijelove 4.4, 4.8, 5.1 i 5.2).
English: NAME OF THE MARKETING AUTHORISATION HOLDER Daiichi-Sankyo (Logo)
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Daiichi-Sankyo (Logo)
English: An allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath.
Croatian: Alergijska reakcija se može prepoznati kao osip, svrbež, oticanje lica, usana ili nedostatak zraka.
English: • Allergic reaction (rash, itching, swollen lips/tongue, or shortness of breath)
Croatian: • alergijska reakcija (osip, svrbež, oticanje usana ili jezika, ili nedostatak zraka)
English: Switching data: Following administration of 75 mg clopidogrel once daily for 10 days, 40 healthy subjects were switched to prasugrel 10 mg once daily with or without a loading dose of 60 mg.
Croatian: Podaci o prebacivanju: Nakon primjene klopidogrela u dozi od 75 mg jedanput na dan tijekom 10 dana, 40 zdravih ispitanika prebačeno je na prasugrel u dozi od 10 mg jedanput na dan, s udarnom dozom od 60 mg ili bez nje.
English: The trial's primary outcome measure was the time to first occurrence of cardiovascular (CV) death, non-fatal myocardial infarction (MI), or non-fatal stroke.
Croatian: Primarna mjera ishoda ovog ispitivanja bilo je vrijeme do prve pojave smrti uzrokovane kardiovaskularnim (KV) događajem, nesmrtonosnog infarkta miokarda (IM) ili nesmrtonosnog moždanog udara.
English: No dose adjustment is necessary for patients with renal impairment, including patients with end stage renal disease (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu u bolesnika s oštećenjem bubrega, uključujući i bolesnike u terminalnoj fazi bubrežne bolesti (vidjeti dio 5.2).
English: Table 2 summarises haemorrhagic and non-haemorrhagic adverse reactions in TRITON, or that were spontaneously reported, classified by frequency and system organ class.
Croatian: Tablici 2 su sažeto prikazane hemoragijske i nehemoragijske nuspojave u ispitivanju TRITON ili iz spontanih prijava, klasificirane prema učestalosti i organskim sustavima.
English: Rates of TIMI major bleeding (including life threatening, fatal and ICH) were similar in prasugrel and clopidogrel treated patients.
Croatian: Stope značajnih krvarenja prema TIMI kriterijima (uključujući po život opasna, smrtonosna i intrakranijalna krvarenja) bile su slične u bolesnika liječenih prasugrelom i onih liječenih klopidogrelom.
English: Microcrystalline cellulose, mannitol (E421), croscarmellose sodium, hypromellose (E464) magnesium stearate, lactose monohydrate, titanium dioxide (E171), triacetin (E1518), iron oxide red (10 mg tablets only) (E172), iron oxide yellow (E172) and talc.
Croatian: Mikrokristalična celuloza, manitol (E421), umrežena karmelozanatrij, hipromeloza (E464), magnezijev stearat, laktoza hidrat, titanijev dioksid (E171), triacetin (E1518), crveni željezov oksid (samo tablete od 10 mg) (E172), žuti željezov oksid (E172) i talk.
English: Not Known
Croatian: Nepoznato
English: A 5 mg maintenance dose should be used.
Croatian: Mora se primjenjivati doza održavanja od 5 mg
English: If, after a careful individual benefit/risk evaluation by the prescribing physician (see section 4.4), treatment is deemed necessary in the patients age group ≥ 75 years, then following a 60 mg loading dose a reduced maintenance dose of 5 mg should be prescribed.
Croatian: Ako nakon pažljive procjene koristi i rizika u svakog pojedinog bolesnika liječnik propisivač (vidjeti dio 4.4) ipak ocijeni da je primjena ovog lijeka neophodna u bolesnika u dobnoj skupini ≥ 75 godina, tada se nakon udarne doze od 60 mg mora propisati niža doza održavanja od 5 mg.
English: The active metabolite's exposure (AUC) has moderate to low between-subject (27%) and within-subject (19%) variability.
Croatian: Izloženost aktivnom metabolitu (AUC) pokazuje umjerenu do malu interindividualnu (27%) i intraindividualnu (19%) varijabilnost.
English: Microcrystalline cellulose Mannitol (E421) Croscarmellose sodium Hypromellose (E464) Magnesium stearate
Croatian: celuloza, mikrokristalična manitol (E421) karmelozanatrij, umrežena hipromeloza (E464) magnezijev stearat
English: • Haematoma (bleeding under the skin at the site of an injection, or into a muscle, causing swelling)
Croatian: • krv u mokraći • hematomi (potkožna krvarenja na mjestu davanja injekcije, ili krvarenja u mišić koja uzrokuju oticanje)
English: It is rapidly hydrolysed in the intestine to a thiolactone, which is then converted to the active metabolite by a single step of cytochrome P450 metabolism, primarily by CYP3A4 and CYP2B6 and to a lesser extent by CYP2C9 and CYP2C19.
Croatian: On se u tankom crijevu vrlo brzo hidrolizira u tiolakton, koji se potom u jednom koraku, pomoću citokroma P450 - pretežito CYP3A4 i CYP2B6, a u manjoj mjeri CYP2C9 i CYP2C19 - pretvara u aktivni metabolit.