FrancophonIA/ELRC3.0 huggingface dataset:
English: A prospective, randomized, open-label, blinded endpoint (PROBE) study (Phase IIIb) to evaluate dual-therapy with dabigatran etexilate (110 mg or 150 mg bid) plus clopidogrel or ticagrelor (P2Y12 antagonist) vs. triple-therapy with warfarin (adjusted to a INR 2.0 - 3.0) plus clopidogrel or ticagrelor and aspirin was conducted in 2725 patients with non valvular atrial fibrillation who underwent a PCI with stenting (RE-DUAL PCI).
Croatian: Prospektivno, randomizirano, otvoreno ispitivanje (faze IIIb) s maskiranim ishodom (PROBE) za procjenu dvojne terapije dabigatraneteksilatom (110 mg ili 150 mg dvaput dnevno) plus klopidogrel ili tikagrelor (antagonisti receptora P2Y12) naspram trojne terapije varfarinom (prilagođenom INR-u 2,0 - 3,0) plus klopidogrel ili tikagrelor i aspirin bilo je provedeno u 2725 bolesnika s nevalvularnom fibrilacijom atrija koji su bilo podvrgnuti zahvatu PCI s ugradnjom stenta (RE-DUAL PCI).
English: There is limited amount of data from the use of Pradaxa in pregnant women.
Croatian: Podaci o primjeni Pradaxe u trudnica su ograničeni.
English: Discontinuation of Pradaxa
Croatian: Prekid primjene Pradaxe
English: Capsule shell Carrageenan Potassium chloride Titanium dioxide Indigo carmine (E132) Hypromellose
Croatian: Ovojnica kapsule karagenan kalijev klorid titanijev dioksid indigo karmin (E 132) hipromeloza
English: Iron oxide black (E172)
Croatian: Crna tinta za označavanje šelak željezov oksid, crni (E172) kalijev hidroksid
English: Based on dabigatran concentrations and clinical assessment, the dose was subsequently modified to a target dose of 2.14 (± 10 %) mg/kg of dabigatran etexilate (100 % of the adult dose adjusted for the patient's weight).
Croatian: Na osnovi koncentracija dabigatrana i kliničke ocjene, doza je naknadno modificirana do ciljne doze od 2,14 (± 10 %) mg/kg dabigatraneteksilata (100 % doze za odrasle prilagođene bolesnikovoj težini).
English: 2-3 days before
Croatian: 2-3 dana prije
English: The administration of a proton-pump inhibitor (PPI) can be considered to prevent GI bleeding.
Croatian: Da bi se spriječilo gastrointestinalno krvarenje, može se razmotriti primjena inhibitora protonske pumpe (PPI).
English: In total, 22 % of patients with atrial fibrillation treated for the prevention of stroke and systemic embolism (long-term treatment for up to 3 years), 14 % of patients treated for DVT/PE and 15 % of patients treated for DVT/PE prevention experienced adverse reactions.
Croatian: Ukupno, oko 22 % bolesnika s fibrilacijom atrija liječenih radi prevencije moždanog udara i sistemske embolije (dugotrajno liječenje do 3 godine), 14% bolesnika liječenih zbog DVT/PE-a i 15% bolesnika liječenih radi prevencije DVT/PE-a imalo je nuspojave.
English: Table 8: Other interactions
Croatian: Druge interakcije Tablica 8: Druge interakcije
English: When severe bleedings occur, treatment must be discontinued, the source of bleeding investigated and use of the specific reversal agent Praxbind (idarucizumab) may be considered (see section 4.9 Management of bleeding complications).
Croatian: Nastupi li teško krvarenje, liječenje treba prekinuti i istražiti izvor krvarenja te razmotriti primjenu specifičnog antagonista Praxbinda (idarucizumab) (vidjeti dio 4.9 Zbrinjavanje komplikacija krvarenja).
English: In animal studies an effect on female fertility was observed in the form of a decrease in implantations and an increase in pre-implantation loss at 70 mg/kg (representing a 5-fold higher plasma exposure level compared to patients).
Croatian: U ispitivanjima na životinjama primijećen je učinak na žensku plodnost u obliku smanjenja implantacija te povećanja predimplantacijskog gubitka pri 70 mg/kg (što predstavlja 5 puta veću izloženost u plazmi u odnosu na terapijske doze u bolesnika).
English: At doses that were toxic to the mothers (representing a 5- to 10-fold higher plasma exposure level to patients), a decrease in foetal body weight and embryofoetal viability along with an increase in foetal variations were observed in rats and rabbits.
Croatian: Pri dozama koje su bile toksične za majku (5 do 10 puta veća izloženost u plazmi u odnosu na bolesnike), primijećeni su smanjenje fetalne tjelesne težine i embriofetalne vitalnosti, zajedno s povećanjem opaženih fetalnih varijacija u štakora i kunića.
English: The study included 4,859 patients on dabigatran etexilate (55% treated with 150 mg bid, 43% treated with 110 mg bid, 2% treated with 75 mg bid).
Croatian: Ispitivanje je uključilo 4859 bolesnika na dabigatraneteksilatu (55% njih bilo je liječeno dozom od 150 mg dvaput dnevno, 43% njih bilo je liječeno dozom od 110 mg dvaput dnevno, 2% njih bilo je liječeno dozom od 75 mg dvaput dnevno).
English: No dose adjustment is necessary for concomitant use of amiodarone or quinidine (see sections 4.4, 4.5 and 5.2).
Croatian: Nije potrebna prilagodba doze u slučaju istodobne primjene Pradaxe i amiodarona ili kinidina (vidjeti dijelove 4.4, 4.5 i 5.2).
English: Dose reductions may be required in combination with some P-gp inhibitors (see sections 4.2, 4.3, 4.4 and 5.1).
Croatian: Kod kombinacije s nekim P-gp inhibitorima mogu biti potrebna sniženja doze (vidjeti dijelove 4.2, 4.3, 4.4 i 5.1).
English: Prevention of blood clot formation after knee or hip replacement surgery The recommended dose is 220 mg once a day (taken as 2 capsules of 110 mg).
Croatian: Sprječavanje stvaranja krvnih ugrušaka nakon kirurškog zahvata ugradnje endoproteze koljena ili kuka Preporučena doza je 220 mg jedanput dnevno (uzeta u obliku 2 kapsule od 110 mg).
English: The primary objective of these studies was to determine if dabigatran etexilate was non-inferior to warfarin in reducing the occurrence of the primary endpoint which was the composite of recurrent symptomatic DVT and/or PE and related deaths within the 6 month treatment period.
Croatian: Primarni cilj ovih ispitivanja bio je odrediti je li dabigatraneteksilat neinferioran varfarinu u smanjenju pojavnosti primarnog ishoda koji je bio kompozitni i sastojao se od rekurentnog simptomatskog DVT-a i/ili PE-a i povezanih smrti unutar razdoblja liječenja u trajanju od 6 mjeseci.
English: Dabigatran is a potent, competitive, reversible direct thrombin inhibitor and is the main active principle in plasma.
Croatian: Dabigatran, glavni aktivni sastojak u plazmi, je snažan, kompetitivan, reverzibilan direktni inhibitor trombina.
English: • Recommendation for kidney function measurement
Croatian: • Preporuke za mjerenje bubrežne funkcije
English: In 2 large randomized, parallel group, double-blind, dose-confirmatory trials, patients undergoing elective major orthopaedic surgery (one for knee replacement surgery and one for hip replacement surgery) received Pradaxa 75 mg or 110 mg within 1-4 hours of surgery followed by 150 mg or 220 mg once daily thereafter, haemostasis having been secured, or enoxaparin 40 mg on the day prior to surgery and daily thereafter.
Croatian: U 2 velika, randomizirana, dvostruko slijepa ispitivanja, za potvrđivanje doze, u bolesnika podvrgnutih velikom elektivnom ortopedskom zahvatu (jedno za ugradnju endoproteze koljena i jedno za ugradnju endoproteze kuka), bolesnici su primili Pradaxu u dozi od 75 mg ili 110 mg unutar 1-4 sata nakon zahvata, nakon čega je slijedila primjena u dozi od 150 mg ili 220 mg jedanput dnevno, uz osiguranu hemostazu, ili enoksaparin u dozi od 40 mg na dan prije kirurškog zahvata i nakon toga svakodnevno.
English: According to the relatively low exposure, coagulation at 72 hrs (presumed dabigatran trough level at steady state or close to steady state conditions) was only slightly prolonged with aPTT at maximum 1.60 fold, ECT 1.86 fold, and Hemoclot
Croatian: Prema relativno niskom izlaganju, koagulacija nakon 72 sata (s pretpostavkom najniže vrijednosti dabigatrana pri stanju dinamičke ravnoteže ili blizu stanja dinamičke ravnoteže) bila je samo blago produljena uz aPTT maksimalno 1,60 puta, ECT 1,86 puta, odnosno Hemoclot
English: The most commonly reported events are bleedings occurring in approximately 16.6 % in patients with atrial fibrillation treated long-term for the prevention of stroke and systemic embolism and in 14.4 % of patients treated for DVT/PE.
Croatian: Najčešće prijavljeni događaji su krvarenja koja su se pojavila u oko 16,6 % bolesnika s fibirilacijom atrija dugotrajno liječenih radi prevencije moždanog udara i sistemske embolije te u 14,4% bolesnika liječenih zbog DVT/PE-a.
English: 150 mg Pradaxa once daily taken as 2 capsules of 75 mg
Croatian: 150 mg Pradaxe jedanput dnevno u obliku 2 kapsule od 75 mg
English: Pradaxa treatment can be re-initiated 24 hours after administration of Praxbind (idarucizumab), if the patient is clinically stable and adequate haemostasis has been achieved.
Croatian: Liječenje Pradaxom može se ponovno započeti 24 sata nakon primjene Praxbinda (idarucizumaba) ako je bolesnik klinički stabilan te ako je postignuta odgovarajuća hemostaza.
English: For situations when rapid reversal of the anticoagulant effect of Pradaxa is required the specific reversal agent (Praxbind, idarucizumab) antagonizing the pharmacodynamic effect of Pradaxa is available (see section 4.4).
Croatian: U situacijama u kojima je potrebno brzo poništenje antikoagulacijskog učinka Pradaxe, dostupan je specifičan antagonist (Praxbind, idarucizumab) koji antagonizira farmakodinamički učinak Pradaxe (vidjeti dio 4.4).
English: How to take Pradaxa
Croatian: Kako uzimati Pradaxu
English: In patients with moderate renal impairment (CrCL 30-50 mL/min), a dose reduction is recommended (see table 1 above and sections 4.4 and 5.1).
Croatian: U skupini bolesnika s umjerenim oštećenjem bubrega (CrCL 30-50 mL/min) preporučuje se sniženje doze (vidjeti tablicu 1 iznad i dijelove 4.4 i 5.1).
English: In the phase III study RE-LY (SPAF, see section 5.1) the overall rate of MI was 0.82, 0.81, and 0.64 % / year for dabigatran etexilate 110 mg twice daily, dabigatran etexilate 150 mg twice daily and warfarin, respectively, an increase in relative risk for dabigatran of 29 % and 27 % compared to warfarin.
Croatian: U studiji faze III pod nazivom RE-LY (prevencija MU i SE kod AF, vidi dio 5.1), ukupna godišnja stopa IM-a bila je 0,82, 0,81 i 0,64 % / godina za dabigatraneteksilat 110 mg dvaput dnevno, dabigatraneteksilat 150 mg dvaput dnevno i varfarin, povećanje relativnog rizika uz dabigatran od 29 % i 27 % u usporedbi s varfarinom.
English: Caution should be exercised when treatment is temporarily discontinued for interventions and anticoagulant monitoring is warranted.
Croatian: Kada se liječenje, zbog intervencije, privremeno prekida, potreban je oprez i nadzor nad koagulacijom.
English: EXP Once opened, the product must be used within 4 months.
Croatian: EXP Nakon prvog otvaranja, lijek se mora upotrijebiti u roku 4 mjeseca.
English: Peak plasma concentrations are reached at 6 hours following administration in a postoperative period due to contributing factors such as anaesthesia, gastrointestinal paresis, and surgical effects independent of the oral medicinal product formulation.
Croatian: Vršne koncetracije u plazmi postižu se 6 sati nakon primjene u postoperativnom razdoblju, uslijed učinaka anestezije, gastrointestinalne pareze i samog zahvata, nezavisno od formulacije oralnog lijeka.
English: The study compared 150 mg twice daily uninterrupted dabigatran etexilate with uninterrupted INR-adjusted warfarin in catheter ablation of paroxysmal or persistent atrial fibrillation.
Croatian: Ispitivanje je usporedilo neprekinuto liječenje dabigatraneteksilatom 150 mg dvaput dnevno s neprekinutim liječenjem varfarinom prilagođenim INR-u kod kateterske ablacije paroksizmalne ili perzistentne fibrilacije atrija.
English: Pradaxa 75 mg are hard capsules with an opaque, white cap and an opaque, white body.
Croatian: Pradaxa 75 mg su tvrde kapsule s neprozirnom, bijelom kapicom i neprozirnim, bijelim tijelom.
English: These studies compared dabigatran etexilate (150 mg bid) with warfarin (target INR 2.0-3.0) in patients with acute DVT and/or PE.
Croatian: Ova ispitivanja uspoređivala su dabigatraneteksilat (150 mg dvaput dnevno) s varfarinom (ciljni INR 2,0 - 3,0) na bolesnicima s akutnim DVT-om i/ili PE-om.
English: • Concomitant treatment with the following strong P-gp inhibitors: systemic ketoconazole, cyclosporine, itraconazole, dronedarone and the fixed-dose combination glecaprevir/pibrentasvir (see section 4.5)
Croatian: • Istodobno liječenje sljedećim snažnim P-gp inhibitorima: sistemskim ketokonazolom, ciklosporinom, itrakonazolom, dronedaronom i fiksnom kombinacijom glekaprevir/pibrentasvir (vidjeti dio 4.5)
English: Clinical trials for the prevention of thromboembolism in patients with prosthetic heart valves
Croatian: Klinička ispitivanja prevencije tromboembolije kod bolesnika s umjetnim srčanim zaliscima
English: For subjects with gastritis, esophagitis, or gastroesophageal reflux, a dose reduction may be considered due to the elevated risk of major gastro-intestinal bleeding (see table 1 above and section 4.4).
Croatian: Za bolesnike s gastritisom, ezofagitisom, ili gastroezofagealnim refluksom, može se razmotriti sniženje doze zbog povećanog rizika od velikog gastrointestinalnog krvarenja (vidjeti tablicu 1 iznad i dio 4.4).
English: • Patients with severe renal impairment (CrCL < 30 mL/min)
Croatian: • Bolesnici s teškim oštećenjem bubrega (CrCl < 30 mL/min)
English: ECT [x-fold upper limit of normal] aPTT [x-fold upper limit of normal] INR
Croatian: ECT [x puta od gornje granice normale] aPTV [x puta od gornje granice normale] INR
English: Clinical trials in Venous Thromboembolism (VTE) prophylaxis following major joint replacement surgery
Croatian: Klinička ispitivanja profilakse venske tromboembolije (VTE) nakon velikog kirurškog zahvata ugradnje endoproteze zgloba
English: Data for the total VTE and all cause mortality endpoint are shown in table 11.
Croatian: Podaci za ukupne VTE i sve uzroke mortaliteta (primarni ishod) prikazani su u tablici 11.
English: For patients with NVAF treated for prevention of stroke and systemic embolism with 150 mg dabigatran etexilate twice daily,
Croatian: Za bolesnike s NVAF-om liječene radi prevencije moždanog udara i sistemske embolije s 150 mg dabigastraneteksilata dvaput dnevno,
English: Risk difference vs. warfarin (%)
Croatian: Razlika rizika naspram varfarina (%)
English: At doses that were toxic to the mothers (5- to 10-fold the plasma exposure level in patients), a decrease in foetal body weight and viability along with an increase in foetal variations were observed in rats and rabbits.
Croatian: Pri dozama koje su bile toksične za majke (5 do 10-struko viša razina izloženosti nego u bolesnika), primijećeni su smanjenje težine tijela fetusa i njegove vitalnosti, zajedno s porastom fetalnih promjena na štakorima i kunićima.
English: For subjects with gastritis, esophagitis, or gastroesophageal reflux, a dose reduction may be considered due to the elevated risk of major gastro-intestinal bleeding (see table 2 above and section 4.4).
Croatian: Za bolesnike s gastritisom, ezofagitisom ili gastroezofagealnim refluksom, može se razmotriti sniženje doze zbog povećanog rizika od velikog gastrointestinalnog krvarenja (vidjeti tablicu 2 iznad i dio 4.4).
English: Common (may affect up to 1 in 10 people): - A fall in the amount of haemoglobin in the blood (the substance in the red blood cells) - Unusual laboratory test results on liver function
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba): - Pad hemoglobina u krvi (tvar koja se nalazi u crvenim krvnim stanicama) - Promijenjeni nalazi laboratorijskih pretraga jetrene funkcije
English: In total, about 9 % of patients treated for elective hip or knee surgery (short-term treatment for up to 42 days), 22 % of patients with atrial fibrillation treated for the prevention of stroke and systemic embolism (long-term treatment for up to 3 years), 14 % of patients treated for DVT/PE and 15 % of patients treated for DVT/PE prevention experienced adverse reactions.
Croatian: Ukupno, oko 9 % bolesnika liječenih zbog elektivnog kirurškog zahvata ugradnje endoproteze kuka ili koljena (kratkotrajno liječenje do 42 dana), 22 % bolesnika s fibrilacijom atrija liječenih radi prevencije moždanog udara i sistemske embolije (dugotrajno liječenje do 3 godine), 14% bolesnika liječenih zbog DVT/PE-a i 15% bolesnika liječenih radi prevencije DVT/PE-a imalo je nuspojave.
English: In the pre- and post-natal study, an increase in foetal mortality was observed at doses that were toxic to the dams (a dose corresponding to a plasma exposure level 4-fold higher than observed in patients).
Croatian: U pre i postnatalnom ispitivanju, primijećeno je povećanje fetalne smrtnosti pri dozama koje su bile toksičneza ženke (doza koja odgovara 4 puta većoj izloženosti u plazmi u odnosu na opažene u bolesnika).
English: Bottle: Once opened, the medicine must be used within 4 months.
Croatian: Boca: Nakon prvog otvaranja, lijek se mora upotrijebiti u roku 4 mjeseca.
English: Although rare in frequency in clinical trials, major or severe bleeding may occur and, regardless of location, may lead to disabling, life-threatening or even fatal outcomes.
Croatian: Iako rijetko po učestalosti u kliničkim ispitivanjima, može doći do velikog ili teškog krvarenja, koje, bez obzira na mjesto, može biti onesposobljavajuće, opasno po život ili čak fatalno.
English: The recommended dose is 300 mg taken as one 150 mg capsule twice a day.
Croatian: Preporučena doza je 300 mg uzeta u obliku jedne kapsule od 150 mg dvaput dnevno.
English: Pradaxa 220 mg once daily
Croatian: Pradaxa 220 mg jedanput dnevno
English: It is recommended to wait 12 hours after the last dose before switching from Pradaxa to a parenteral anticoagulant (see section 4.5).
Croatian: Preporučuje se čekati 12 sati nakon posljednje doze prije prijelaza s liječenja Pradaxom na liječenje parenteralnim antikoagulansom (vidjeti dio 4.5).
English: - The black printing ink contains shellac, iron oxide black and potassium hydroxide.
Croatian: - Crna tinta za označavanje sadrži šelak, crni željezov oksid i kalijev hidroksid.
English: gMean (gCV %; range) half-life [h]
Croatian: Geometrijska srednja vrijednost (gCV%; raspon) poluvijek [h]
English: • an aPTT ratio greater than 2-fold upper limit of normal (aPTT prolongation of about 80 seconds), at trough (10-16 hours after the previous dose) reflects the 90
Croatian: • aPTV omjer veći od 2 puta od gornje granice normale (aPTV produljenje od oko 80 sekundi), pri kraju dozirnog intervala (10 - 16 sati nakon prethodne doze) odražava 90. percentilu opservacija.
English: Benefit-risk assessment The presence of lesions, conditions, procedures and/or pharmacological treatment (such as NSAIDs, antiplatelets, SSRIs and SNRIs, see section 4.5), which significantly increase the risk of major bleeding requires a careful benefit-risk assessment.
Croatian: Prisustvo lezija, stanja, postupaka, i/ili farmakološkog liječenja (kao što su NSAIL-i, antitrombocitni lijekovi, SSRI-i i SNRI-i, vidjeti dio 4.5), koji značajno povećavaju rizik od velikog krvarenja zahtijeva pažljivu ocjenu omjera koristi i rizika.
English: Contact your doctor if you experience indigestion after taking Pradaxa.
Croatian: Obratite se liječniku ako nakon uzimanja Pradaxe imate probavne tegobe.
English: Close clinical surveillance is recommended in patients with renal impairment.
Croatian: Preporučuje se poman klinički nadzor nad bolesnicima s oštećenjem bubrežne funkcije.
English: The recommended doses of Pradaxa and the duration of therapy for primary prevention of venous thromboembolism in orthopaedic surgery are shown in table 1.
Croatian: Preporučene doze Pradaxe i trajanje terapije kod primarne prevencije venske tromboembolije u ortopedskoj kirurgiji prikazani su u tablici 1.
English: DVT/PE treatment and DVT/PE prevention
Croatian: Liječenje DVT/PE-a i prevencija DVT/PE-a
English: Table 9: Other interactions
Croatian: Druge interakcije Tablica 9: Druge interakcije
English: ASA Co-administration of ASA and 150 mg dabigatran etexilate twice daily may increase the risk for any bleeding from 12 % to 18 % and 24 % with 81 mg and 325 mg ASA, respectively (see section 4.4).
Croatian: Istodobna primjena acetilsalicilatne kiseline i 150 mg dabigatraneteksilata dvaput dnevno može povećati rizik od krvarenja s 12 % na 18 %, uz 81 mg acetilsalicilatne kiseline, odnosno na 24 %, uz 325 mg acetilsalicilatne kiseline (vidjeti dio 4.4).
English: Use of proton-pump inhibitors
Croatian: Primjena inhibitora protonske pumpe
English: Subacute surgery/interventions
Croatian: Subakutni kirurški zahvati/ intervencije
English: Diseases / procedures with special haemorrhagic risks
Croatian: Bolesti / postupci s posebnim rizicima od krvarenja
English: ECT [x-fold upper limit of normal] No data aPTT [x-fold upper limit of normal] > 1.3 INR
Croatian: ECT [x puta od gornje granice normale] Nema podataka aPTV [x puta od gornje granice normale] > 1,3 INR
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Croatian: Neklinički podaci o sigurnosnoj farmakologiji, toksičnosti ponovljenih doza i genotoksičnosti nisu ukazali na potencijalan rizik za ljude.
English: - The other ingredients are tartaric acid, acacia, hypromellose, dimeticone 350, talc, and hydroxypropylcellulose.
Croatian: Drugi sastojci su: tartaratna kiselina, arapska guma, hipromeloza, dimetikon 350, talk i hidroksipropilceluloza.
English: INFORMATION IN BRAILLE Pradaxa 75 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Pradaxa 75 mg
English: Better results were seen with the 220 mg dose where the point estimate of Major VTE was slightly better than enoxaparin (table 10).
Croatian: Bolji rezultati su primijećeni uz dozu od 220 mg pri kojoj je točkovna procjena teškog VTE-a bila neznatno bolja nego uz enoksaparin (tablica 10).
English: This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
Croatian: To može uključivati trenutnu ili nedavnu gastrointestinalnu ulceraciju, prisustvo maligne neoplazme s visokim rizikom od krvarenja, nedavna ozljeda mozga ili spinalna ozljeda, nedavni moždani, spinalni, ili oftalmološki kirurški zahvat, nedavno intrakranijalno krvarenje, poznati ili suspektni ezofagealni varikoziteti, arteriovenske malformacije, vaskularna aneurizma, ili značajne intraspinalne ili intracerebralne vaskularne abnormalnosti
English: Furthermore a higher risk of MI was seen in patients concomitantly taking ASA plus clopidogrel or clopidogrel alone.
Croatian: Nadalje, viši rizik od IM-a primijećen je u bolesnika koji su istodobno uzimali acetilsalicilatnu kiselinu i klopidogrel, ili sam klopidogrel.
English: Peak plasma concentrations are reached at 6 hours following administration in a postoperative period due to contributing factors such as anaesthesia, GI paresis, and surgical effects independent of the oral medicinal product formulation.
Croatian: Vršne koncetracije u plazmi postižu se 6 sati nakon primjene u postoperativnom razdoblju, uslijed učinaka anestezije, GI pareze i samog zahvata, nezavisno od formulacije oralnog lijeka.
English: Better results were seen with the 220 mg dose where the point estimate of Major VTE was slightly better than enoxaparin (table 17).
Croatian: Bolji rezultati su primijećeni uz dozu od 220 mg pri kojoj je točkovna procjena teškog VTE-a bila neznatno bolja nego uz enoksaparin (tablica 17).
English: No dose adjustment is required (see section 4.2).
Croatian: Nije potrebna prilagodba doze (vidjeti dio 4.2).