FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor if you have or have had any medical conditions or illnesses, in particular any of those included in the following list:
Croatian: Obavijestite liječnika ako imate ili ste imali medicinska stanja ili bolesti, posebice one sa slijedećeg popisa:
English: No difference was found for major bleeding (hazard ratio 0.97, CI 0.88 - 1.07).
Croatian: Za veliko krvarenje nije bila pronađena razlika (omjer hazarda 0,97, CI 0,88 - 1,07).
English: dTT [ng/mL]
Croatian: dTV [ng/mL]
English: There is a clear correlation between plasma dabigatran concentration and degree of anticoagulant effect based on phase II studies.
Croatian: Postoji jasna povezanost između koncentracije dabigatrana u plazmi i stupnja antikoagulacijskog učinka koja se temelji na studijama faze II.
English: In actively controlled VTE prevention trials 6,684 patients were treated with 150 mg or 220 mg Pradaxa daily.
Croatian: U aktivno kontroliranim ispitivanjima prevencije VTE-a, 6684 bolesnika bila su liječena sa 150 mg ili 220 mg Pradaxe dnevno.
English: ® is an oral anticoagulant (direct thrombin inhibitor).
Croatian: ® je oralni antikoagulans (direktni inhibitor trombina).
English: Itraconazole, cyclosporine
Croatian: Itrakonazol, ciklosporin
English: Pradaxa treatment to Vitamin K antagonists (VKA):
Croatian: Prijelaz s liječenja Pradaxom na antagoniste vitamina K (VKA):
English: Both dose strengths of Pradaxa had also a statistically significant lower total bleed rate.
Croatian: Obje doze Pradaxe imale su statistički značajno nižu ukupno stopu krvarenja.
English: Assessment of renal function prior to and during Pradaxa treatment
Croatian: Procjena bubrežne funkcije prije i tijekom liječenja Pradaxom
English: The anticoagulant activity of dabigatran decreased with decreasing plasma concentrations and the PK/PD relationship was not affected by the procedure.
Croatian: Antikoagulacijska aktivnost dabigatrana se smanjila sa sniženjem koncentracija u plazmi, a postupak nije utjecao na odnos PK/PD.
English: There are no clinical data of the effect of dabigatran on infants during breast-feeding.
Croatian: Ne postoje klinički podaci o učinku dabigatrana na dijete tijekom dojenja.
English: If possible, Pradaxa should be discontinued at least 24 hours before invasive or surgical procedures.
Croatian: Ukoliko postoji mogućnost, primjenu Pradaxe je potrebno prekinuti najmanje 24 sata prije invazivnih ili kirurških postupaka.
English: None of these diseases showed an impact on the effects of dabigatran on VTE-prevention or bleeding rates.
Croatian: Niti jedna od ovih bolesti nije pokazala utjecaj na učinke dabigatrana u prevenciji VTE-a ili stope krvarenja.
English: No clinically relevant ethnic differences among Caucasians, African-American, Hispanic, Japanese or Chinese patients were observed.
Croatian: Nisu primijećene klinički relevantne etničke razlike u populaciji bolesnika bijelaca, AfroAmerikanaca, Hispanaca, Japanaca, ili Kineza.
English: Pradaxa affects blood clotting, so most side effects are related to signs such as bruising or bleeding.
Croatian: Pradaxa utječe na zgrušavanje krvi, tako da je većina nuspojava povezana sa znakovima kao što su pojava modrica ili krvarenje.
English: A surgery / intervention should be delayed if possible until at least 12 hours after the last dose.
Croatian: Kirurški zahvat/intervenciju je potrebno, ukoliko postoji mogućnost, odgoditi za najmanje 12 sati nakon posljednje doze.
English: Additional requirements in patients with mild to moderate renal impairment and in patients aged over 75 years:
Croatian: Dodatni zahtjevi u skupini bolesnika s blagim do umjerenim oštećenjem bubrega i bolesnika iznad 75 godina:
English: Enoxaparin 40 mg
Croatian: Enoksaparin 40 mg
English: Do not stop taking Pradaxa without talking to your doctor first, because the risk of developing a blood clot could be higher if you stop treatment too early.
Croatian: Ne prekidajte primjenu Pradaxe prije nego što ste o tome razgovarali s liječnikom jer rizik od razvoja krvnog ugruška može biti viši ako prerano prestanete s liječenjem.
English: Four positional isomers, 1-O, 2-O, 3-O, 4-O-acylglucuronide exist, each accounts for less than 10 % of total dabigatran in plasma.
Croatian: Postoje četiri pozicijska izomera,1-O, 2-O, 3-O, 4-O-acilglukuronid, svaki odgovara za manje od 10 % ukupnog dabigatrana u plazmi.
English: Instructions for the bottle
Croatian: Upute za otvaranje boce
English: In clinical trials, Pradaxa was associated with higher rates of major gastrointestinal (GI) bleeding.
Croatian: U kliničkim ispitivanjima, Pradaxa je bila povezana s višom stopom velikog gastrointestinalnog (GI) krvarenja.
English: • Active clinically significant bleeding
Croatian: • Aktivno klinički značajno krvarenje
English: Although Pradaxa does not in general require routine anticoagulant monitoring, the measurement of dabigatran related anticoagulation may be helpful to detect excessive high exposure to dabigatran in the presence of additional risk factors.
Croatian: Iako Pradaxa općenito ne zahtijeva antikoagulacijsko praćenje, mjerenje antikoagulacijskog učinka dabigatrana može biti korisno u otkrivanju previsoke izloženosti dabigatranu u prisustvu dodatnih čimbenika rizika.
English: No double dose should be taken to make up for missed individual doses.
Croatian: Ne smije se uzimati dvostruka doza kako bi se nadoknadila propuštena pojedinačna doza.
English: - if you have had a heart attack or if you have been diagnosed with conditions that increase the risk to develop a heart attack.
Croatian: ako ste imali srčani udar ili Vam je dijagnosticirano stanje koje povećava rizik nastanka srčanog udara.
English: Due to the pharmacological mode of action, the use of Pradaxa may be associated with an increased risk of occult or overt bleeding from any tissue or organ.
Croatian: Zbog farmakološkog načina djelovanja, primjena Pradaxe može biti povezana s povećanim rizikom od okultnog ili vidljivog krvarenja iz bilo kojeg tkiva ili organa.
English: When taking a hard capsule out of the bottle, the following instructions should be observed:
Croatian: Prilikom uzimanja tvrde kapsule iz boce, potrebno je slijediti sljedeće upute:
English: • Recent biopsy, major trauma
Croatian: • nedavna biopsija ili velika trauma
English: Specific pharmacokinetic phase I studies with elderly subjects showed an increase of 40 to 60 % in the AUC and of more than 25 % in Cmax compared to young subjects.
Croatian: Posebna farmakokinetička ispitivanja faze I na starijim ispitanicima pokazala su porast u AUC od 40 do 60 % i porast Cmax veći od 25 % u usporedbi s mladim ispitanicima.
English: The capsules can be taken with or without food.
Croatian: Kapsule se mogu uzeti sa ili bez hrane.
English: Patients at high surgical mortality risk and with intrinsic risk factors for thromboembolic events
Croatian: Bolesnici s visokim rizikom intraoperativne smrtnosti i s intrinzičnim čimbenicima rizika za tromboembolijske događaje
English: Bleeding can occur at any site during therapy with Pradaxa.
Croatian: Krvarenje se može pojaviti na bilo kojem mjestu tijekom terapije Pradaxom.
English: Number of patients treated with Pradaxa
Croatian: Broj bolesnika liječenih Pradaxom
English: After removal of a catheter, an interval of at least 2 hours should elapse before the administration of the first dose of Pradaxa.
Croatian: Nakon uklanjanja katetera, potreban je interval od najmanje 2 sata prije primjene prve doze Pradaxe.
English: The oral bioavailability may be increased by 75 % after a single dose and 37 % at steady state compared to the reference capsule formulation when the pellets are taken without the Hydroxypropylmethylcellulose (HPMC) capsule shell.
Croatian: Oralna bioraspoloživost može se povećati za 75 % nakon jednokratne doze i 37 % pri stanju dinamičke ravnoteže u usporedbi s referentnom formulacijom u kapsuli kada se pelete uzimaju bez hidroksipropilmetilceluloznog (HPMC) tijela kapsule.
English: The most commonly reported events are bleedings occurring in approximately 14 % of patients; the frequency of major bleeds (including wound site bleedings) is less than 2 %.
Croatian: Najčešće prijavljeni događaji su krvarenja koja su se pojavila u oko 14 % bolesnika; učestalost velikih krvarenja (uključujući krvarenja iz rane) je manja od 2%.
English: Diluted thrombin time (dTT), ecarin clotting time (ECT) and activated partial thromboplastin time (aPTT) may provide useful information, but results should be interpreted with caution due to inter-test variability (see section 5.1).
Croatian: Razrijeđeno trombinsko vrijeme (dTV), ekarinsko vrijeme zgrušavanja (ECT) i aktivirano parcijalno tromboplastinsko vrijeme (aPTV) mogu dati korisne podatke, ali rezultati se moraju interpretirati s oprezom zbog varijabilnosti između testova (vidjeti dio 5.1).
English: This is explained by completed dabigatran absorption after 2 hours.
Croatian: Ovo se objašnjava potpunom apsorpcijom dabigatrana nakon 2 sata.
English: In the studied patient population of RE-MODEL and RE-NOVATE (5,539 patients treated), 51 % suffered from concomitant hypertension, 9 % from concomitant diabetes, 9 % from concomitant coronary artery disease and 20 % had a history of venous insufficiency.
Croatian: U ispitivanoj populaciji bolesnika RE-MODEL i RE-NOVATE ispitivanja (5 539 liječenih bolesnika), 51 % je imalo popratnu hipertenziju, 9 % popratni dijabetes, 9 % popratnu koronarnu arterijsku bolest i 20 % je imalo u povijesti bolesti vensku insuficijenciju.
English: This resulted in a removal of 50 % to 60 % of dabigatran concentrations, respectively.
Croatian: Ovo je rezultiralo uklanjanjem 50 % do 60 % koncentracija dabigatrana, po istom redoslijedu.
English: When clinically relevant bleeding occurs, treatment should be interrupted.
Croatian: Kada se pojavi klinički relevantno krvarenje, potrebno je prekinuti liječenje.
English: Any bleeding
Croatian: Svako krvarenje
English: Patients who underwent Percutaneous coronary intervention (PCI) with stenting
Croatian: Bolesnici koji su bili podvrgnuti perkutanoj koronarnoj intervenciji (PCI) s ugradnjom stenta
English: Myocardial Infarction (MI)
Croatian: Infarkt miokarda (IM)
English: In all patients and especially in the elderly (>75 years), as renal impairment may be frequent in this age group:
Croatian: U svih bolesnika, a osobito starijih osoba (>75 godina), jer oštećenje bubrega može biti često u toj dobnoj skupini:
English: DVT/PE prevention (RE-MEDY, RESONATE)
Croatian: Prevencija DVT/PE-a (RE-MEDY, RESONATE)
English: The clinical studies have been conducted in a patient population with a mean age > 65 years.
Croatian: Klinička ispitivanja provedena su na populaciji bolesnika prosječne dobi > 65 godina.
English: • Whenever the risk management system is modified, especially as th result of new information being received that may lead to significant change to the benefit/risk profile or as the result.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: It works by blocking a substance in the body which is involved in blood clot formation.
Croatian: Djeluje blokiranjem tvari u tijelu koja sudjeluje u stvaranju krvnih ugrušaka.
English: 10 days (knee replacement surgery) or 28-35 days (hip replacement surgery)
Croatian: 10 dana (kirurški zahvat ugradnje endoproteze koljena) ili 28-35 dana (kirurški zahvat ugradnje endoproteze kuka)
English: • Other medicinal products which may impair haemostasis
Croatian: • drugi lijekovi koji mogu narušiti hemostazu
English: • Follow your doctor's instructions when taking Pradaxa ®.
Croatian: • Slijedite upute svog liječnika tijekom primjene Pradaxe ®.
English: The ECT can provide a direct measure of the activity of direct thrombin inhibitors.
Croatian: ECT može osigurati direktno mjerenje aktivnosti direktnih inhibitora trombina.
English: The capsule should be swallowed whole with a glass of water, to ensure delivery to the stomach.
Croatian: Kapsula se treba progutati cijela, s čašom vode kako bi se osiguralo njezino dospijevanje do želuca.
English: Therefore INR tests should not be performed.
Croatian: Stoga se INR pretraga ne treba provoditi.
English: In such cases a coagulation test (see sections 4.4 and 5.1) may help to determine whether haemostasis is still impaired.
Croatian: U takvim slučajevima test koagulacije (vidjeti dijelove 4.4 i 5.1) može pomoći u određivanju je li hemostaza još uvijek poremećena.
English: Do not use this medicine after the expiry date which is stated on the carton, blister or bottle after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, blisteru ili boci iza oznake „EXP“.
English: • After taking the capsule out, the cap should be returned on the bottle right away and the bottle should be tightly closed.
Croatian: • Nakon vađenja kapsule, zatvarač je potrebno smjesta vratiti na bocu i bocu čvrsto zatvoriti.
English: Patients on Pradaxa who undergo surgery or invasive procedures are at increased risk for bleeding.
Croatian: Bolesnici na Pradaxi koji su podvrgnuti kirurškom zahvatu ili invazivnim postupcima imaju povećan rizik od krvarenja.
English: RE-MODEL (knee)
Croatian: RE-MODEL (koljeno) Br.
English: Amiodarone When Pradaxa was co-administered with a single oral dose of 600 mg amiodarone, the extent and rate of absorption of amiodarone and its active metabolite DEA were essentially unchanged.
Croatian: Kada je Pradaxa primjenjivana istodobno s jednokratnom oralnom dozom od 600 mg amiodarona, opseg i brzina apsorpcije amiodarona i njegovog aktivnog metabolita DEA u osnovi su bili nepromijenjeni.
English: This educational pack is aimed at increasing awareness about the potential risk of bleeding during treatment with Pradaxa and providing guidance on how to manage that risk.
Croatian: Ovaj edukativni paket je namijenjen podizanju svijesti o potencijalnom riziku od krvarenja tijekom liječenja Pradaxom te kako zbrinuti spomenute rizike.
English: Until then, INR values should be interpreted with caution.
Croatian: Do tada, potreban je oprez u interpretaciji INR vrijednosti.
English: Change of anticoagulant treatment
Croatian: Promjena liječenja antikoagulansima
English: Possible side effects are listed below, grouped by how likely they are to happen.
Croatian: Moguće nuspojave su niže navedene, klasificirane prema vjerojatnosti njihovog pojavljivanja.
English: • Push and turn for opening.
Croatian: • Pritisnite i okrenite kako biste otvorili
English: In this small number of adolescents, dabigatran etexilate capsules were apparently tolerated with only three mild and transient gastrointestinal adverse events reported by two patients.
Croatian: Kod ovako malog broja adolescenata, kapsule dabigatraneteksilata su se očigledno dobro podnosile sa samo tri blage i prolazne gastrointestinalne nuspojave koje su prijavila dva bolesnika.
English: The safety of Pradaxa has been evaluated in ten phase III studies including 23,393 patients exposed to Pradaxa (see Table 10).
Croatian: Sigurnost Pradaxe procijenjena je u deset ispitivanja faze III u koja je bilo uključeno 23 393 bolesnika izloženih Pradaxi (vidjeti tablicu 10).
English: However, the aPTT test has limited sensitivity and is not suitable for precise quantification of anticoagulant effect, especially at high plasma concentrations of dabigatran.
Croatian: Međutim, aPTV test ima ograničenu osjetljivost te nije prikladan za precizno određivanje antikoagulacijskog učinka, posebice pri visokim koncentracijama dabigatrana u plazmi.
English: Life-threatening bleeding was reported in 0.46 per 100 patient-years, intracranial haemorrhage in 0.17 per 100 patient-years and gastrointestinal bleeding in 0.60 per 100 patient-years.
Croatian: Životno opasno krvarenje bilo je zabilježeno u 0,46 na 100 bolesnik-godina, intrakranijalno krvarenje u 0,17 na 100 bolesnik-godina i gastrointestinalno krvarenje u 0,60 na 100 bolesnik-godina.
English: Of the 704 enrolled patients, 317 underwent atrial fibrillation ablation on uninterrupted dabigatran and 318 underwent atrial fibrillation ablation on uninterrupted warfarin.
Croatian: Od 704 uključenih bolesnika, njih 317 bilo je podvrgnuto ablaciji fibrilacije atrija na neprekinutom dabigatranu, a njih 318 bilo je podvrgnuto ablaciji fibrilacije atrija na neprekinutom varfarinu.
English: RELY-ABLE (Long term multi-center extension of dabigatran treatment in patients with atrial fibrillation who completed the RE-LY trial)
Croatian: RELY-ABLE (Dugoročni, multicentrični produžetak liječenja dabigatranom u bolesnika s atrijskom fibrilacijom koji su završili ispitivanje RE-LY)
English: Hence, the integrity of the HPMC capsules should always be preserved in clinical use to avoid unintentionally increased bioavailability of dabigatran etexilate (see section 4.2).
Croatian: Stoga, integritet HPMC kapsula uvijek mora biti sačuvan u kliničkoj primjeni kako bi se izbjeglo neželjeno povećanje bioraspoloživosti dabigatraneteksilata (vidjeti dio 4.2).
English: In this situation Pradaxa and these medicinal products should be taken at the same time.
Croatian: U ovoj situaciji, Pradaxa i spomenuti lijekovi trebaju se uzimati u isto vrijeme.
English: Other dabigatran related anti-coagulation tests were not changed significantly by the pre-treatment of enoxaparin.
Croatian: Ostali antikoagulacijski testovi povezani s dabigatranom nisu bili značajno promijenjeni prethodnim liječenjem enoksaparinom.
English: P-gp substrate Digoxin
Croatian: P-gp supstrat Digoksin
English: DVT/PE treatment (RECOVER, RE-COVER II)
Croatian: Liječenje DVT/PE-a (RE-COVER, RECOVER II)
English: There is some experimental evidence to support the role of these medicinal products in reversing the anticoagulant effect of dabigatran, but data on their usefulness in clinical settings and also on the possible risk of rebound thromboembolism is very limited.
Croatian: Postoje određeni eksperimentalni dokazi koji idu u prilog ulozi ovih lijekova u vraćanju antikoagulacijskog učinka dabigatrana, ali podaci o njihovim pozitivnim učincima u kliničkom okruženju te također o mogućem riziku povratka (rebound) tromboembolije su vrlo ograničeni.
English: Do not break, chew, or empty the pellets from the capsule since this may increase the risk of bleeding.
Croatian: Ne lomite, žvačite i ne praznite pelete iz kapsule jer može doći do povećanog rizika od krvarenja.
English: A prospective, randomized, open-label, multicenter, exploratory study with blinded, centrally adjudicated endpoint evaluation (RE-CIRCUIT) was conducted in 704 patients who were under stable anticoagulant treatment.
Croatian: Prospektivno, randomizirano, otvoreno, multicentrično, eksplorativno ispitivanje s centralno vođenom ocjenom ishoda na maskiran način (RE-CIRCUIT) provedeno je u 704 bolesnika koji su bili na stabilnom liječenju antikoagulansom.
English: The patient population was 64 % male, 70 % Caucasian and 16 % Asian.
Croatian: Uzorak je sačinjavalo 64 % muškaraca, 70 % bijelaca i 16 % Azijaca.
English: Haemorrhagic complications may present as weakness, paleness, dizziness, headache or unexplained swelling, dyspnoea, and unexplained shock.
Croatian: Hemoragijske komplikacije mogu se manifestirati kao slabost, bljedilo, omaglica, glavobolja ili neobjašnjeno oticanje, dispneja i neobjašnjeni šok.
English: Tables 20-22 display details of key results in the overall population:
Croatian: Tablice 20-22 sažimaju ključne rezultate studije za ukupnu populaciju:
English: DVT/PE The duration of therapy should be individualised after careful assessment of the treatment benefit against the risk for bleeding (see section 4.4).
Croatian: DVT/PE Trajanje liječenja mora se prilagoditi individualnim potrebama nakon pažljive procjene koristi liječenja u odnosu na rizike od krvarenja (vidjeti dio 4.4).
English: It is recommended to continue with the remaining daily doses of Pradaxa at the same time of the next day.
Croatian: Preporučuje se nastaviti s preostalim dnevnim dozama Pradaxe u isto vrijeme sljedećeg dana.
English: For dose modifications in this population see table 1 above.
Croatian: Za prilagodbe doze u ovoj populaciji vidjeti tablicu 1 iznad.
English: Selective serotonin re-uptake inhibitors (SSRIs) or selective serotonin norepinephrine re-uptake inhibitors (SNRIs)
Croatian: Selektivni inhibitori ponovne pohrane serotonina (SSRI-i) ili selektivni inhibitori ponovne pohrane serotonina i noradrenalina (SNRI-i)
English: Pradaxa contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants.
Croatian: Pradaxa sadrži djelatnu tvar dabigatraneteksilat i pripada skupini lijekova koji se nazivaju antikoagulansi.
English: The relative risk of bleeding with dabigatran compared to warfarin increased with age.
Croatian: Relativni rizik od krvarenja uz dabigatran u usporedbi s varfarinom se povećao s dobi.
English: Pre-dosing of the probe inducer rifampicin at a dose of 600 mg once daily for 7 days decreased total dabigatran peak and total exposure by 65.5 % and 67 %, respectively.
Croatian: Prethodno doziranje induktora rifampicina u dozi od 600 mg jedanput dnevno u trajanju 7 dana, smanjilo je ukupnu vršnu i ukupnu izloženost dabigatranu za 65,5 % i 67 %.
English: Pantoprazole and other proton-pump inhibitors (PPI) were co-administered with Pradaxa in clinical trials, and concomitant PPI treatment did not appear to reduce the efficacy of Pradaxa.
Croatian: Pantoprazol i drugi inhibitori protonske pumpe (PPI) bili su istodobno primjenjivani s Pradaxom u kliničkim ispitivanjima, a istodobno liječenje PPI-om nije smanjilo djelotvornost Pradaxe.
English: From 6 hours prior to the next scheduled dose on, the missed dose should be omitted.
Croatian: Nakon 6 sati prije planirane sljedeće doze, propuštena doza se preskače.
English: Close clinical surveillance
Croatian: Poman klinički nadzor
English: Treatment initiation on the day of surgery 1-4 hours after completed surgery
Croatian: Početak liječenja na dan kirurškog zahvata 1-4 sata nakon završetka kirurškog zahvata
English: No dose adjustment is necessary (see section 5.2), but close clinical surveillance is recommended in patients with a body weight < 50 kg (see section 4.4).
Croatian: Nije potrebna prilagodba doze (vidjeti dio 5.2), ali preporučuje se poman klinički nadzor nad bolesnicima s tjelesnom težinom < 50 kg (vidjeti dio 4.4).
English: The risk of spinal or epidural haematoma may be increased in cases of traumatic or repeated puncture and by the prolonged use of epidural catheters.
Croatian: Rizik spinalnog ili epiduralnog hematoma može biti povećan u slučajevima traumatske ili ponovljene punkcije te produljenom primjenom epiduralnih katetera.
English: Continue with your remaining daily doses of Pradaxa at the same time of the next day.
Croatian: Nastavite s preostalim dnevnim dozama Pradaxe u isto vrijeme sljedećeg dana.
English: Not known
Croatian: Rijetko nije poznato
English: Active substance exposure in the primary VTE prevention studies was about 40 % to 50 % higher in female patients and no dose adjustment is recommended.
Croatian: Izloženost djelatnoj tvari u ispitivanjima primarne prevencije VTE-a u ženskih bolesnica je oko 40 % do 50 % veće te se ne preporučuje prilagodba doze.
English: Pradaxa should be temporarily discontinued.
Croatian: Primjenu Pradaxe potrebno je privremeno prekinuti.
English: In atrial fibrillation patients females had on average 30 % higher trough and post-dose concentrations.
Croatian: Žene s fibrilacijom atrija imale su u prosjeku 30% više minimalne koncentracije kao i koncentracije nakon doziranja.
English: Concomitant use not recommended e.g. ritonavir and its combinations with other protease inhibitors
Croatian: Istodobna primjena se ne preporučuje npr. ritonavir i njegove kombinacije s drugim inhibitorima proteaze
English: • Details of populations potentially at higher risk of bleeding
Croatian: • Detalje o skupinama koje su pod potencijalno većim rizikom od krvarenja
English: • CrCL ≥ 50 mL/min, VKA should be started 3 days before discontinuing Pradaxa
Croatian: • CrCL ≥ 50 mL/min, s primjenom VKA treba započeti 3 dana prije prekida Pradaxe