FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients at risk of bleeding
Croatian: Bolesnici s rizikom od krvarenja
English: The RE-LY extension study (RELY-ABLE) provided additional safety information for a cohort of patients which continued the same dose of dabigatran etexilate as assigned in the RE-LY trial.
Croatian: Produžetak ispitivanja RE-LY (RELY-ABLE) pružio je dodatne sigurnosne informacije za kohortu bolesnika koja je nastavila primati jednaku dozu dabigatraneteksilata kao onu koja im je bila određena u ispitivanju RE-LY.
English: Any GI bleeds *HR not estimable as there is no event in either one cohort/treatment
Croatian: * Omjer hazarda (HR, engl. hazard ratio) se ne može ocijeniti jer nema događaja niti u jednoj kohorti/jednom liječenju
English: SSRIs, SNRIs SSRIs and SNRIs increased the risk of bleeding in all treatment groups of a phase III clinical trial comparing dabigatran to warfarin for stroke prevention in atrial fibrillation patients (RE-LY).
Croatian: SSRI-i i SNRI-i su povećali rizik od krvarenja u svim liječenim skupinama kliničkog ispitivanja faze III u kojem su se uspoređivali dabigatran i varfarin za prevenciju moždanog udara u bolesnika s fibrilacijom atrija (RE-LY).
English: • Renal function should be assessed by calculating the creatinine clearance (CrCL) prior to initiation of treatment with Pradaxa to exclude patients with severe renal impairment (i.e. CrCL < 30 mL/min) (see sections 4.3, 4.4 and 5.2).
Croatian: • Bubrežna funkcija se ocjenjuje tako da se izračuna klirens kreatinina (CrCL) prije početka liječenja Pradaxom kako bi se isključili bolesnici s teškim oštećenjem bubrega (tj. CrCL < 30 mL/min) (vidjeti dijelove 4.3, 4.4 i 5.2).
English: Limited clinical data in patients < 50 kg are available.
Croatian: Kliničko iskustvo s bolesnicima < 50 kg je ograničeno.
English: For both surgeries, if haemostasis is not secured, initiation of treatment should be delayed.
Croatian: Ukoliko hemostaza nije osigurana, kod oba zahvata potrebno je odgoditi početak liječenja.
English: The dabigatran trough concentrations were about 20 % lower in patients with a body weight > 100 kg compared with 50-100 kg.
Croatian: Minimalne koncentracije dabigatrana bile su oko 20 % niže u bolesnika s tjelesnom težinom > 100 kg u usporedbi s 50-100 kg.
English: Clarithromycin When clarithromycin (500 mg twice daily) was administered together with dabigatran etexilate in healthy volunteers, increase of AUC by about 1.19-fold and Cmax by about 1.15-fold was observed.
Croatian: Kada se klaritromicin (500 mg dvaput dnevno) primjenjivao zajedno s dabigatraneteksilatom u zdravih dobrovoljaca, AUC je povećan za oko 1,19 puta, a Cmax za oko 1,15 puta.
English: Take Pradaxa as your physician has told you.
Croatian: Uzimajte Pradaxu kako Vam je rekao liječnik.
English: In vivo and ex vivo animal studies have demonstrated antithrombotic efficacy and anticoagulant activity of dabigatran after intravenous administration and of dabigatran etexilate after oral administration in various animal models of thrombosis.
Croatian: In vivo i ex vivo ispitivanja na životinjama pokazala su antitrombotsku djelotvornost i antikoagulacijsku aktivnost dabigatrana nakon intravenske primjene te dabigatraneteksilata nakon peroralne primjene u raznim modelima tromboze.
English: The median CrCL in RE-LY was 68.4 mL/min.
Croatian: Medijan CrCL u ispitanika u studiji RE-LY bio je 68,4 mL/min.
English: A forgotten Pradaxa dose may still be taken up to 6 hours prior to the next scheduled dose.
Croatian: Zaboravljena doza Pradaxe može se još uvijek uzeti do 6 sati prije sljedeće planirane doze prema rasporedu doziranja.
English: The risk of bleedings may be increased in certain patient groups e.g. those patients with moderate renal impairment and/or on concomitant treatment affecting haemostasis or strong P-gp inhibitors (see section 4.4 Haemorrhagic risk).
Croatian: Rizik od krvarenja može biti povećan u određenih skupina bolesnika, npr. bolesnika s umjerenim oštećenjem bubrega i/ili na istodobnom liječenju koje utječe na hemostazu ili na liječenju snažnim P-gp inhibitorima (vidjeti dio 4.4 Rizik od krvarenja).
English: Importance of treatment compliance Necessity to carry the Patient alert card with them at all times The need to inform Health Care Professionals about all medicines they are currently taking The need to inform Health Care Professionals that they are taking Pradaxa if they need to have any surgery or invasive procedure.
Croatian: Važnosti suradljivosti u liječenju Nužnosti da Kartice s upozorenjima za bolesnike stalno nose sa sobom Potrebi za informiranjem medicinskih djelatnika o svim lijekovima koje trenutno uzimaju
English: Table 10: Number of patients studied, maximum daily dose in phase III studies Indication
Croatian: Tablica 10: Broj bolesnika u ispitivanjima, maksimalna dnevna doza u ispitivanjima faze III Indikacija
English: Women of childbearing potential should avoid pregnancy during treatment with Pradaxa.
Croatian: Žene reproduktivne dobi moraju izbjegavati trudnoću tijekom liječenja Pradaxom.
English: Faecal excretion accounted for 6 % of the administered dose.
Croatian: Stolicom je izlučeno 6 % primijenjene doze.
English: Treatment with Pradaxa in patients with severe renal impairment (CrCL < 30 mL/min) is contraindicated (see section 4.3).
Croatian: Liječenje Pradaxom bolesnika s teškim oštećenjem bubrega (CrCL < 30 mL/min) je kontraindicirano (vidjeti dio 4.3).
English: Furthermore, bleeding occurred in 19.4 % of patients in the DVT/PE prevention trial RE-MEDY and in 10.5 % of patients in the DVT/PE prevention trial RE-SONATE.
Croatian: Nadalje, krvarenje se pojavilo kod 19,4% bolesnika u RE-MEDY ispitivanju prevencije DVT/PE-a, i kod 10,5% bolesnika u RE-SONATE ispitivanju prevencije DVT/PE-a.
English: The greatest elevation of dabigatran exposure was observed with the first dose of an immediate release formulation of verapamil administered one hour prior to the dabigatran etexilate intake (increase of Cmax by about 2.8-fold and AUC by about 2.5-fold).
Croatian: Najizraženije povećanje izloženosti dabigatranu primijećeno je uz prvu dozu formulacije verapamila s trenutnim oslobađanjem primijenjenom jedan sat prije unosa dabigatraneteksilata (povećanje Cmax za oko 2,8 puta i AUC za oko 2,5 puta).
English: With improving monitoring of INR the observed benefits of dabigatran etexilate compared to warfarin diminish.
Croatian: S poboljšanjem praćenja INR-a, korist dabigatraneteksilata u usporedbi s varfarinom se smanjuje.
English: Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease.
Croatian: Poništenje terapije dabigatranom izlaže bolesnike riziku od tromboze zbog njihove osnovne bolesti.
English: Never skip a dose or stop the intake of Pradaxa
Croatian: Ne propuštajte uzeti dozu i ne prekidajte primjenu Pradaxe
English: The efficacy and safety was investigated in two multi-center, randomised, double blind, parallelgroup, replicate studies RE-COVER and RE-COVER II.
Croatian: Djelotvornost i sigurnost su ispitivane u RE-COVER i RE-COVER II, dvama multicentričnim, randomiziranim, dvostruko slijepim, repliciranim ispitivanjima paralelnih skupina.
English: Dabigatran inhibits free thrombin, fibrin-bound thrombin and thrombin-induced platelet aggregation.
Croatian: Dabigatran inhibira slobodni trombin, trombin vezan na fibrin i agregaciju trombocita induciranu trombinom.
English: The safety of Pradaxa has been evaluated in a pivotal study investigating the prevention of stroke and systemic embolism in patients with atrial fibrillation, in two active controlled DVT/PE treatment trials and in one active controlled DVT/PE prevention trial.
Croatian: Sigurnost Pradaxe procijenjena je u ključnom ispitivanju prevencije moždanog udara i sistemske embolije u bolesnika s atrijskom fibrilacijom, u dva aktivno kontrolirana ispitivanja liječenja DVT/PEa i jednom aktivno kontroliranom ispitivanju prevencije DVT/PE-a.
English: Speak to your doctor immediately if you experience any of the following possible signs and symptoms of bleeding: swelling, discomfort, unusual pain or headache, dizziness, paleness, weakness, unusual bruising, nosebleeds, bleeding of gums, unusual long bleeding cuts, abnormal menstrual flow or vaginal bleeding, blood in your urine which may be pink or brown, red/black stools, coughing up blood, vomiting blood or coffee ground like material.
Croatian: Odmah se obratite liječniku ako razvijete bilo koji od sljedećih mogućih znakova i simptoma krvarenja: oticanje, nelagodu, neobičan bol ili glavobolju, omaglicu, bljedilo, slabost, neobične modrice, krvarenje iz nosa, krvarenje desni, neobično dugotrajno krvarenje iz posjekotina, abnormalno menstruacijsko ili vaginalno krvarenje, krv u mokraći koja može biti ružičasta ili smeđa, crvene/crne stolice, iskašljavanje krvi, povraćanje krvi ili sadržaja nalik talogu kave.
English: When dabigatran etexilate (150 mg) was co-administered with oral verapamil, the Cmax and AUC of dabigatran were increased but the magnitude of this change differs depending on timing of administration and formulation of verapamil (see sections 4.2 and 4.4).
Croatian: Kada je dabigatraneteksilat (150 mg) primjenjen istodobno s oralnim verapamilom, Cmax i AUC dabigatrana su se povećali, ali opseg promjena varirao je ovisno o vremenu primjene i formulaciji verapamila (vidjeti dijelove 4.2. i 4.4.).
English: RE-SONATE demonstrated dabigatran etexilate was superior to placebo for the prevention of recurrent symptomatic DVT/PE events including unexplained deaths, with a risk reduction from 5.6 % to 0.4 % (relative risk reduction 92 % based on hazard ratio ) during the treatment period (p<0.0001).
Croatian: RE-SONATE je pokazao da je dabigatranetekislat bio superioran placebu u prevenciji rekurentnih simptomatskih događaja DVT/PE-a uključujući neobjašnjene smrti, sa smanjenjem rizika s 5,6% na 0,4% (smanjenje relativnog rizika 92% temeljeno na omjera hazarda) tijekom razdoblja liječenja (p < 0,0001).
English: 30 x 1 hard capsule
Croatian: 30 x 1 tvrda kapsula
English: Close observation for signs of bleeding is recommended in patients concomitantly treated with NSAIDs (see section 4.5).
Croatian: Preporučuje se pomno promatranje zbog znakova krvarenja u bolesnika koji se istodobno liječe NSAIL-ovima (vidjeti dio 4.5).
English: Tear off one individual blister from the blister card along the perforated line
Croatian: Pojedini blister otrgnite od pločice blistera po perforaciji
English: There is very limited clinical experience in patients with a body weight < 50 kg or > 110 kg at the recommended posology.
Croatian: Kliničko iskustvo u bolesnika s tjelesnom težinom < 50 kg ili > 110 kg pri preporučenom načinu doziranja je vrlo ograničeno.
English: Spinal anaesthesia/epidural anaesthesia/lumbar puncture
Croatian: Spinalna anestezija/epiduralna anestezija/lumbalna punkcija
English: These are switching anticoagulant therapy (see section 4.2), when UFH is given at doses necessary to maintain an open central venous or arterial catheter or when UFH is given during catheter ablation for atrial fibrillation (see section 4.5)
Croatian: To su prijelaz u antikoagulacijskoj terapiji (vidjeti dio 4.2), kada se UFH daje pri dozama potrebnima za održavanje prohodnosti središnjeg venskog ili arterijskog katetera ili kada se UFH daje tijekom kateterske ablacije radi fibrilacije atrija (vidjeti dio 4.5)
English: Patients with gastritis, esophagitis or gastroesophageal reflux
Croatian: Bolesnici s gastritisom, ezofagitisom ili gastroezofagealnim refluksom
English: After oral administration of Pradaxa in healthy volunteers, the pharmacokinetic profile of dabigatran in plasma is characterized by a rapid increase in plasma concentrations with Cmax attained within 0.5 and 2.0 hours post administration.
Croatian: Nakon peroralne primjene Pradaxe u zdravih dobrovoljaca, farmakokinetički profil dabigatrana u plazmi karakteriziran je naglim povećanjem koncentracija u plazmi s Cmax postignutim u roku 0,5 i 2,0 sata nakon primjene.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Pradaxa in all subsets of the paediatric population for the granted indications (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Pradaxa u svim podskupinama pedijatrijske populacije za odobrenu indikaciju (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: A dose reduction should be either considered or is recommended as indicated in section 4.2.
Croatian: Potrebno je razmotriti sniženje doze ili se preporučuje sniženje doze kako je indicirano u dijelu 4.2.
English: There was no stroke/systemic embolism/TIA (composite) event in the dabigatran etexilate arm, and one event (TIA) in the warfarin arm from the time of ablation and until 8 weeks post-ablation.
Croatian: U skupini koja je primala dabigatraneteksilat nije bilo događaja moždanog udara/sistemske embolije/TIA (kompozitni), a u skupini koja je primala varfarin bio je jedan događaj (TIA) od trenutka ablacije do 8 tjedana nakon ablacije.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Pradaxa in all subsets of the paediatric population in prevention of thromboembolic events for the granted indication (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Pradaxa u svim podskupinama pedijatrijske populacije u prevenciji tromboembolijskih događaja za odobrenu indikaciju (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: The volume of distribution of dabigatran of 60-70 L exceeded the volume of total body water indicating moderate tissue distribution of dabigatran.
Croatian: Volumen distribucije dabigatrana od 60-70 L prelazi volumen ukupne tjelesne tekućine i ukazuje na umjerenu raspodjelu dabigatrana u tkiva.
English: 95 % confidence interval
Croatian: Interval pouzdanosti 95 %
English: All bleeding events which occurred during warfarin therapy are included except for those during the overlap period between warfarin and parenteral therapy.
Croatian: Uključeni su svi događaji krvarenja koji su se javili tijekom liječenja varfarinom osim onih koji su se javili tijekom razdoblja preklapanja između varfarina i parenteralnog liječenja.
English: 95% confidence interval non-inferiority margin Secondary efficacy endpoints Recurrent symptomatic VTE and allcause deaths
Croatian: Interval pouzdanosti 95% Granica neinferiornosti Sekundarni ishodi djelotvornosti Rekurentni simptomatski VTE i smrti svih uzroka
English: The dabigatran AUC and Cmax were increased by about 1.6-fold and 1.5-fold, respectively.
Croatian: AUC i Cmax dabigatrana povećali su se za oko 1,6 puta odnosno 1,5 puta.
English: if you have had a serious injury (e.g. a bone fracture, head injury or any injury requiring surgical treatment).
Croatian: ako ste tijekom proteklog mjeseca bili na kirurškom zahvatu uzimanja tkiva (biopsija). ako ste imali tešku ozljedu (npr. prijelom kosti, ozljeda glave ili ozljeda koja zahtijeva kirurško liječenje).
English: Treated patients
Croatian: Liječeni bolesnici
English: The intended therapy was 6 months dabigatran etexilate 150 mg twice daily without need for monitoring.
Croatian: Ciljano liječenje bilo je 6 mjeseci dabigatraneteksilata 150 mg dvaput dnevno bez potrebe za praćenjem.
English: Patients following elective knee replacement surgery single capsule of 110 mg Pradaxa
Croatian: Bolesnici nakon elektivnog kirurškog zahvata ugradnje endoproteze koljena jedna kapsula Pradaxe od 110 mg
English: Consideration should also be given to administration of platelet concentrates in cases where thrombocytopenia is present or long acting antiplatelet medicinal products have been used.
Croatian: Potrebno je uzeti u obzir primjenu koncentrata trombocita u slučajevima prisutne trombocitopenije ili primjene antitrombocitnih lijekova dugog djelovanja.
English: Pradaxa should be used with caution in conditions with an increased risk of bleeding or with concomitant use of medicinal products affecting haemostasis by inhibition of platelet aggregation.
Croatian: Pradaxa se primjenjuje s oprezom u stanjima s povećanim rizikom od krvarenja ili uz istodobnu primjenu lijekova koji utječu na hemostazu putem inhibiranja agregacije trombocita.
English: NSAIDs given for short-term analgesia have been shown not to be associated with increased bleeding risk when given in conjunction with dabigatran etexilate.
Croatian: Pokazalo se da NSAIL-i koji se daju radi kratkotrajne analgezije nisu povezani s povećanim rizikom od krvarenja kada se daju istodobno uz dabigatraneteksilat.
English: You should not breast-feed while you are taking Pradaxa.
Croatian: Ne biste smjeli dojiti dok uzimate Pradaxu.
English: Pradaxa dabigatran etexilate
Croatian: Pradaxa dabigatraneteksilat
English: Patients with elevated liver enzymes > 2 ULN were excluded in controlled clinical trials investigating the VTE prevention following elective hip or knee replacement surgery.
Croatian: Bolesnici s povišenim vrijednostima jetrenih enzima > 2 vrijednosti gornje granice normale bili su isključeni iz kontroliranih kliničkih ispitivanja prevencije VTE-a nakon elektivnog kirurškog zahvata ugradnje endoproteze kuka ili koljena.
English: On subsequent days absorption of dabigatran is rapid with peak plasma concentrations attained 2 hours after medicinal product administration.
Croatian: Sljedećih dana apsorpcija dabigatrana je brza, s najvišim koncentracijama u plazmi postignutim 2 sata nakon primjene lijeka.
English: This regimen resulted in a geometric mean trough concentration of 155 ng/ml (gCV of 76.9 %), measured immediately before administration of the next dose and in a geometric mean peak concentration of 202 ng/ml (gCV of 70.6 %) measured two hours after the administration of the last dose.
Croatian: Ovaj režim doveo je do geometrijske srednje vrijednosti najniže koncentracije od 155 ng/ml (gCV od 76,9 %), izmjerene neposredno prije primjene sljedeće doze i geometrijske srednje vrijednosti vršne koncentracije od 202 ng/ml (gCV od 70,6 %) izmjerene dva sata nakon primjene zadnje doze.
English: No clinically relevant inter-ethnic differences among Caucasian, African-American, Hispanic, Japanese or Chinese patients were observed regarding dabigatran pharmacokinetics and pharmacodynamics.
Croatian: Nisu primijećene klinički relevantne međuetničke razlike u skupinama bolesnika bijelaca, AfroAmerikanaca, osoba hispanskog porijekla, Japanaca, ili Kineza, s obzirom na farmakokinetiku i farmakodinamiku dabigatrana.
English: In case of intolerability to Pradaxa, patients should be instructed to immediately consult their treating physician in order to be switched to alternate acceptable treatment options for prevention of stroke and systemic embolism associated with atrial fibrillation or for DVT/PE.
Croatian: U slučaju nepodnošljivosti Pradaxe, bolesnike je potrebno uputiti da se trenutno jave svom liječniku radi prijelaza na drugu prihvatljivu terapiju za prevenciju moždanog udara i sistemske embolije povezanih s fibrilacijom atrija ili za DVT/PE.
English: However, limited clinical data with another P-gp substrate (everolimus) suggest that the inhibition of P-gp with tacrolimus is weaker than that observed with strong P-gp inhibitors.
Croatian: P-gp supstratu (everolimus) ukazuju da je inhibicija P-gp-a uz takrolimus slabija nego što je primijećena uz snažne P-gp inhibitore.
English: It is recommended to wait 24 hours after the last dose before switching from Pradaxa to a parenteral anticoagulant (see section 4.5).
Croatian: Preporučuje se čekati 24 sata nakon posljednje doze, prije prelaska s Pradaxe na parenteralni antikoagulans (vidjeti dio 4.5).
English: Ranitidine administration together with Pradaxa had no clinically relevant effect on the extent of absorption of dabigatran.
Croatian: Primjena ranitidina zajedno s Pradaxom nije imala klinički relevantan učinak na opseg apsorpcije dabigatrana.
English: In the clinical study 1160.88 in total, 9 adolescent patients (age 12 to < 18 years) with diagnosis of primary VTE received an initial oral dose of dabigatran etexilate of 1.71 (± 10 %) mg/kg bodyweight.
Croatian: U kliničkom ispitivanju 1160.88 ukupno, 9 je adolescentskih bolesnika (u dobi od 12 do < 18 godina) s dijagnozom primarnog VTE-a primalo početnu peroralnu dozu dabigatraneteksilata od 1,71 (± 10 %) mg/kg tjelesne težine.
English: Recurrent symptomatic VTE and VTE-related death
Croatian: Rekurentni simptomatski VTE i smrt povezana s VTEom
English: However, for patients with high risk of bleeding, a dose reduction of Pradaxa to 220 mg taken as one 110 mg capsule twice daily should be considered (see sections 4.4 and 5.2).
Croatian: Međutim, za bolesnike s visokim rizikom od krvarenja, potrebno je razmotriti sniženje doze Pradaxe na 220 mg u obliku jedne kapsule od 110 mg dvaput dnevno (vidjeti dijelove 4.4 i 5.2).
English: Pradaxa ® Information for Patients About your treatment
Croatian: Pradaxa® Informacije za bolesnike
English: Active Cancer Patients (DVT/PE)
Croatian: Bolesnici s rakom u aktivnoj fazi bolesti (DVT/PE)
English: which would be 1.3-fold upper limit of normal.
Croatian: 51 sekunda, što je 1,3 puta od gornje granice normale.
English: • Thrombocytopenia or functional platelet defects
Croatian: • trombocitopenija ili funkcionalni defekti trombocita
English: 60 x 1 hard capsule
Croatian: 60 x 1 tvrda kapsula
English: Major bleeding occurred in 0.97 per 100 patient-years.
Croatian: Veliko krvarenje javilo se u 0,97 na 100 bolesnikgodina.
English: Cautions to be exercised in case concomitant use (see sections 4.2 and 4.4)
Croatian: Potreban oprez u slučaju istodobne primjene (vidjeti dijelove 4.2 i 4.4)
English: All patients underwent a Trans-oesophageal Echocardiography (TEE) prior to catheter ablation.
Croatian: Svi su bolesnici prije kateterske ablacije bili podvrgnuti transezofagealnoj ehokardiografiji (TEE).
English: 21.7 % of patients had mild renal impairment (CrCL > 50 - < 80 mL/min) and 4.5% of patients had a moderate renal impairment (CrCL between 30 and 50 mL/min).
Croatian: 21,7 % bolesnika imalo je blago oštećenje bubrega (CrCL > 50 - < 80 mL/min) i 4,5% bolesnika imalo je umjereno oštećenje bubrega (CrCL između 30 i 50 mL/min).
English: • A specific reversal agent (Praxbind ®) is available (please refer to the Summary of Product
Croatian: • Dostupan je specifičan antagonist (Praxbind ®) (pogledajte Sažetak opisa svojstava lijeka za
English: There was no meaningful interaction observed when verapamil was given 2 hours after dabigatran etexilate (increase of Cmax by about 1.1-fold and AUC by about 1.2-fold).
Croatian: Nije bilo značajnih interakacija kada se verapamil uzimao 2 sata nakon dabigatraneteksilata (povećanje Cmax za oko 1,1 puta i AUC za oko 1,2 puta).
English: On treatment 2 (22.1 %) patients experienced mild related adverse events (gastrooesophageal reflux / abdominal pain; abdominal discomfort) and 1 (11.1 %) patient experienced a not related serious adverse event (recurrent VTE of the leg) in the post treatment period > 3 days after stop of dabigatran etexilate.
Croatian: Bolesnici na liječenju 2 (22,1 %) imali su blage povezane nuspojave (gastroezofagealni refluks / abdominalna bol; nelagoda u abdomenu), a 1 (11,1 %) bolesnik je imao nepovezanu tešku nuspojavu (rekurentni VTE noge) u razdoblju nakon liječenja > 3 dana nakon prekida primjene dabigatraneteksilata.
English: Almost half (45.8 %) of the RE-LY patients had a CrCL > 50-< 80 mL/min.
Croatian: Gotovo polovina (45,8 %) ispitanika imala je CrCL > 50- < 80 mL/min.
English: In the early post-operative patients, major bleeding manifested predominantly as haemorrhagic pericardial effusions, specifically in patients who started dabigatran etexilate early (i.e. on Day 3) after heart valve replacement surgery (see section 4.3).
Croatian: Kod bolesnika u ranom postoperativnom razdoblju veliko krvarenje manifestiralo se uglavnom u obliku hemoragijskih perikardijalnih efuzija, osobito kod bolesnika koji su počeli s primjenom dabigatraneteksilata u ranoj fazi (tj. 3. dan) nakon kirurškog zahvata ugradnje umjetnog srčanog zaliska (vidjeti dio 4.3).