FrancophonIA/ELRC3.0 huggingface dataset:
English: • Renal function should be assessed in all patients by calculating the creatinine clearance (CrCL) prior to initiation of treatment with Roteas to exclude patients with end stage renal disease (i.e. CrCL < 15 mL/min), to use the correct Roteas dose in patients with CrCL 15 - 50 mL/min (30 mg once daily), in patients with CrCL > 50 mL/min (60 mg once daily) and when deciding on the use of Roteas in patients with increased creatinine clearance (see section 4.4).
Croatian: • Funkciju bubrega treba procijeniti u svih bolesnika izračunavanjem klirensa kreatinina (CrCL) prije početka liječenja Roteasom kako bi se isključili bolesnici u završnom stadiju bubrežne bolesti (tj. CrCL < 15 ml/min) i primijenila ispravna doza Roteasa u bolesnika s CrCL 15 - 50 ml/min (30 mg jedanput na dan), u bolesnika s CrCL > 50 ml/min (60 mg jedanput na dan) te kad se odlučuje o primjeni Roteasa u bolesnika s povećanim klirensom kreatinina (vidjeti dio 4.4).
English: Interaction with other medicinal products affecting haemostasis Concomitant use of medicines affecting haemostasis may increase the risk of bleeding.
Croatian: Interakcija s drugim lijekovima koji utječu na hemostazu Istovremena primjena lijekova koji utječu na hemostazu može povećati rizik od krvarenja.
English: (e.g. stomach ulcer, injury or bleeding in the brain, or recent surgery of the brain or eyes) - if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, rivaroxaban,
Croatian: (npr. vrijed želuca, ozljedu mozga ili krvarenje u mozak ili nedavni kirurški zahvat na mozgu ili očima) - ako uzimate druge lijekove za sprječavanje zgrušavanja krvi (npr. varfarin, dabigatran,
English: Edoxaban decreased the Cmax and AUC of concomitantly administered verapamil by 14% and 16%, respectively.
Croatian: Edoksaban je smanjio Cmax i AUC istovremeno primijenjenog verapamila za 14% odnosno 16%.
English: Thus, medicines or disease conditions that increase gastric emptying and gut motility have the possibility of reducing edoxaban dissolution and absorption.
Croatian: Stoga lijekovi ili bolesti koje pojačavaju pražnjenje želuca i motilitet crijeva mogu smanjiti otapanje i apsorpciju edoksabana.
English: • Bleeding from the nose
Croatian: • krvarenje iz nosa
English: • Bleeding from a surgical wound following an operation
Croatian: • krvarenje iz kirurške rane nakon operacije
English: Your doctor will determine when to restart Roteas.
Croatian: Liječnik će odrediti kada ćete ponovno početi uzimati Roteas.
English: - If your body weight is 60 kg or lower, the recommended dose is one 30 mg tablet once daily.
Croatian: - Ako imate tjelesnu težinu od 60 kg ili nižu, preporučena doza je jedna tableta od 30 mg jedanput na dan.
English: • Unexplained tiredness
Croatian: • neobjašnjivi umor
English: The European Medicines Agency has deferred the obligation to submit the results of studies with edoxaban in one or more subsets of the paediatric population in prevention of arterial thrombosis, treatment of thromboembolism and prevention of thromboembolism (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka edoksaban u svim podskupinama pedijatrijske populacije u sprječavanju arterijske tromboze, liječenju tromboembolije i prevenciji tromboembolije (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: • Prescriber Guide for healthcare professionals
Croatian: • Vodič za zdravstvene djelatnike koji propisuju lijek
English: Subjects were maintained on treatment for 28 days post cardioversion.
Croatian: Poslije kardioverzije ispitanici su zadržani na liječenju 28 dana.
English: Table 3 provides the list of adverse reactions from the two pivotal Phase 3 studies in patients with VTE (DVT and PE) (Hokusai-VTE study) and AF (ENGAGE AF-TIMI 48 study) combined for both indications.
Croatian: Tablica 3 daje sažeti popis nuspojava iz dva glavna ispitivanja faze 3 u bolesnika s VTE-om (DVT i PE) (ispitivanje Hokusai-VTE) i AF-om (ispitivanje ENGAGE AF-TIMI 48), kombinirano za obje indikacije.
English: • Bleeding from the vagina
Croatian: • krvarenje iz vagine
English: Woman of childbearing potential Women of childbearing potential should avoid becoming pregnant during treatment with edoxaban.
Croatian: Žene reproduktivne dobi trebaju izbjegavati trudnoću tijekom liječenja edoksabanom.
English: Therefore Roteas is contraindicated during breast-feeding (see section 4.3).
Croatian: Stoga je Roteas kontraindiciran tijekom dojenja (vidjeti dio 4.3).
English: Haemodynamically unstable PE patients or patients who require thrombolysis or pulmonary embolectomy
Croatian: Hemodinamski nestabilni bolesnici s PE-om ili bolesnici kojima je potrebna tromboliza ili plućna trombektomija
English: ICH non-fatal CRNM Bleeding n
Croatian: ICH bez smrtnog ishoda CRNM krvarenje n
English: Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTE) The recommended dose is 60 mg edoxaban once daily following initial use of parenteral anticoagulant for at least 5 days (see section 5.1).
Croatian: Liječenje DVT-a, liječenje PE-a i prevencija ponavljajućih DVT-a i PE-a (VTE) Preporučena doza je 60 mg edoksabana jedanput na dan nakon početne primjene parenteralnog antikoagulansa tijekom najmanje 5 dana (vidjeti dio 5.1).
English: • problems with the blood vessels in your brain or spinal column
Croatian: • tegobe s krvnim žilama u mozgu ili kralježnici
English: Direct acting Oral Anticoagulants (DOACs) including edoxaban are not recommended for patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome.
Croatian: Direktno djelujući oralni antikoagulansi (engl. direct acting oral anticoagulants, DOAC), uključujući edoksaban, ne preporučuju se bolesnicima koji u anamnezi imaju trombozu a dijagnosticiran im je antifosfolipidni sindrom.
English: Table 1: Summary of posology in NVAF and VTE (DVT and PE) Summary Guide for Dosing
Croatian: Tablica 1: Sažeti prikaz doziranja kod NVAF-a i VTE-a (DVT i PE) Kratke smjernice za doziranje
English: The edoxaban clinical programme for atrial fibrillation was designed to demonstrate the efficacy and safety of two dose groups of edoxaban compared to warfarin for the prevention of stroke and systemic embolism in subjects with nonvalvular atrial fibrillation and at moderate to high risk of stroke and systemic embolic events (SEE).
Croatian: Klinički program ispitivanja edoksabana kod atrijske fibrilacije bio je ustrojen tako da pokaže djelotvornost i sigurnost dvije dozne skupine edoksabana u usporedbi s varfarinom u prevenciji moždanog udara i sistemske embolije u ispitanika s nevalvularnom fibrilacijom atrija i umjerenim do visokim rizikom od moždanog udara i sistemskih embolijskih događaja (SED).
English: The recommended dose is one 60 mg tablet once daily.
Croatian: Preporučena doza je jedna tableta od 60 mg jedanput na dan.
English: Roteas should be restarted after the surgical or other procedures as soon as adequate haemostasis has been established, noting that the time to onset of the edoxaban anticoagulant therapeutic effect is 1 - 2 hours.
Croatian: Nakon kirurških ili drugih postupaka, s primjenom Roteasa treba ponovno započeti čim se uspostavi odgovarajuća hemostaza, uzimajući u obzir da antikoagulacijski terapijski učinak edoksabana nastupa nakon 1 - 2 sata.
English: Safety and efficacy of edoxaban have not been established in pregnant women.
Croatian: Sigurnost i djelotvornost edoksabana u trudnica nisu ustanovljene.
English: In a population pharmacokinetic analysis of the ENGAGE AF-TIMI 48 study in NVAF, Cmax and AUC in patients with median low body weight (55 kg) were increased by 40% and 13%, respectively, as compared with patients with median high body weight (84 kg).
Croatian: U analizi populacijske farmakokinetike u ispitivanju ENGAGE AF-TIMI 48 kod NVAF-a, u bolesnika s medijanom niske tjelesne težine (55 kg) Cmax i AUC bili su povećani za 40% odnosno 13% u usporedbi s bolesnicima s medijanom visoke tjelesne težine (84 kg).
English: Within renal function subgroups, results for the secondary efficacy endpoints were consistent with those for the primary endpoint.
Croatian: Unutar podskupina prema funkciji bubrega, rezultati za sekundarne ishode djelotvornosti bili su sukladni onima za primarni ishod.
English: Inhibition of factor Xa in the coagulation cascade reduces thrombin generation, prolongs clotting time and reduces the risk of thrombus formation.
Croatian: Inhibicijom faktora Xa u koagulacijskoj kaskadi smanjuje se stvaranje trombina, produljuje vrijeme zgrušavanja i smanjuje rizik od stvaranja tromba.
English: Your doctor will need to do blood measurements and will instruct you when to stop taking Roteas.
Croatian: Liječnik će morati napraviti krvne pretrage i onda će Vam dati uputu kada da prestanete uzimati Roteas.
English: Roteas contains the active substance edoxaban and belongs to a group of medicines called anticoagulants.
Croatian: Što je Roteas i za što se koristi Roteas sadrži djelatnu tvar edoksaban i pripada skupini lijekova koji se zovu antikoagulansi.
English: In clinical studies, co-administration of NSAIDs resulted in increased clinically relevant bleeding.
Croatian: kliničkim je ispitivanjima istovremena primjena NSAR-ova rezultirala povećanim klinički značajnim krvarenjem.
English: Co-administration of protonpump inhibitors had no relevant impact on edoxaban exposure.
Croatian: Istovremena primjena s inhibitorima protonske pume nije imala značajan utjecaj na izloženost edoksabanu.
English: • That all patients should be provided with a Patient alert card and be counselled about: The signs or symptoms of bleeding and when to seek attention from a healthcare provider Importance of treatment compliance Necessity to carry the Patient alert card with them at all times The need to inform Health Care Professionals that they are taking Roteas if they need to have any surgery or invasive procedure
Croatian: znakovima ili simptomima krvarenja i kada da potraže pomoć zdravstvenog djelatnika važnosti pridržavanja liječenja potrebi da uvijek sa sobom nose Karticu s upozorenjima za bolesnika potrebi da obavijeste zdravstvene djelatnike o tome da uzimaju lijek Roteas ako se moraju podvrgnuti nekom kirurškom zahvatu ili invazivnom postupku.
English: In the comparator arm, subjects received initial heparin therapy concurrently with warfarin, titrated to a target INR of 2.0 to 3.0, followed by warfarin alone.
Croatian: U skupini koja je primala komparator, ispitanici su primali početnu terapiju heparinom istovremeno s varfarinom, titriranim do ciljnog INR-a od 2,0 do 3,0, a nakon toga samo varfarin.
English: Roteas is contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk (see section 4.3).
Croatian: Roteas je kontraindiciran u bolesnika s bolešću jetre povezanom s koagulopatijom i klinički značajnim rizikom od krvarenja (vidjeti dio 4.3).
English: In a study on male and female fertility in rats no effects were seen (see section 5.3).
Croatian: U ispitivanju na štakorima nisu opaženi nikakvi učinci na plodnost mužjaka i ženki (vidjeti dio 5.3).
English: Changes observed in these clotting tests are expected at the therapeutic dose, however, these changes are small, subject to a high degree of variability, and not useful in monitoring the anticoagulation effect of edoxaban.
Croatian: Promjene opažene u ovim pretragama zgrušavanja očekivane su pri terapijskoj dozi; međutim, te su promjene male, podložne velikom stupnju varijabilnosti i nisu korisne u praćenju antikoagulacijskog učinka edoksabana.
English: Population PK modeling indicates that exposure approximately doubles in patients with severe renal impairment (CrCL 15 - 29 mL/min) relative to patients with normal renal function.
Croatian: Populacijsko farmakokinetičko modeliranje pokazuje da se izloženost skoro pa udvostručuje u bolesnika s teškim oštećenjem funkcije bubrega (CrCL 15 - 29 ml/min) u odnosu na onu kod bolesnika s normalnom funkcijom bubrega.
English: The main analysis of efficacy was aimed to show the non-inferiority of edoxaban versus warfarin on first stroke or SEE that occurred during treatment or within 3 days from the last dose taken in the modified intention-to-treat (mITT) population.
Croatian: Cilj glavne analize bio je pokazati neinferiornost edoksabana naspram varfarina kod prvog moždanog udara ili SED-a koji je nastao tijekom liječenja ili unutar 3 dana od zadnje uzete doze u populaciji liječenoj modificiranim planiranim liječenjem (mITT, engl. modified intention-to-treat).
English: Appropriate symptomatic treatment could be used as needed, such as mechanical compression (e.g. for severe epistaxis), surgical haemostasis with bleeding control procedures, fluid replacement and haemodynamic support, blood products (packed red cells or fresh frozen plasma, depending on associated anaemia or coagulopathy) or platelets.
Croatian: Po potrebi se može primijeniti odgovarajuće simptomatsko liječenje, kao što su mehanička kompresija (npr. kod teške epistakse), kirurška hemostaza uz postupke kontrole krvarenja, nadoknada tekućine i hemodinamska potpora, krvni pripravci (koncentrat eritrocita ili svježe zamrznuta plazma, ovisno o popratnoj anemiji ili koagulopatiji) ili trombociti.
English: • Details of the population potentially at higher risk of bleeding
Croatian: • podatke o populaciji koja može imati veći rizik od krvarenja
English: In animal reproduction studies, rabbits showed increased incidence of gallbladder variations at a dosage of 200 mg/kg which is approximately 65 times the maximum recommended human dose (MRHD) of 60 mg/day based on total body surface area in mg/m2.
Croatian: U reproduktivnim ispitivanjima na životinjama, u kunića se pokazala povećana incidencija varijacija žučnog mjehura pri dozama od 200 mg/kg, što je približno 65 puta veća doza od maksimalne preporučene doze za ljude (MRHD) od 60 mg/dan koja se temelji na ukupnoj površini tijela u mg/m2.
English: How to take the tablet Swallow the tablet, preferably with water.
Croatian: Progutajte tabletu po mogućnosti s vodom.
English: Edoxaban had no effect on the Cmax and AUC of quinidine.
Croatian: Edoksaban nije utjecao na Cmax i AUC kinidina.
English: Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).
Croatian: Liječenje duboke venske tromboze (DVT) i plućne embolije (PE) te prevencija ponavljajućih DVT-a i PE-a u odraslih (vidjeti dio 4.4 za hemodinamski nestabilne bolesnike s PE-om).
English: A trend towards decreasing efficacy with increasing creatinine clearance was observed for edoxaban compared to well-managed warfarin (see section 5.1).
Croatian: Opažen je trend prema smanjenju djelotvornosti edoksabana s povećanjem klirensa kreatinina u usporedbi s dobro titriranim varfarinom (vidjeti dio 5.1).
English: These patients are to be carefully monitored for signs and symptoms of bleeding complications and anaemia after initiation of treatment (see section 4.8).
Croatian: U tih bolesnika nakon početka liječenja mora se pozorno pratiti pojava znakova i simptoma komplikacija zbog krvarenja i anemije (vidjeti dio 4.8).
English: Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTE) 30 mg QD ≥ 30 to ≤ 50
Croatian: Liječenje DVT-a, liječenje PE-a i prevencija ponavljajućih DVT-a i PE-a (VTE) 30 mg QD ≥ 30 do ≤ 50
English: Edoxaban was excreted in the breast milk of lactating rats.
Croatian: Edoksaban se izlučuje u mlijeku ženki štakora tijekom laktacije.
English: • Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran etexilate, rivaroxaban, apixaban etc.) except under specific circumstances of switching oral anticoagulant therapy (see section 4.2) or when UFH is given at doses necessary to maintain an open central venous or arterial catheter (see section 4.5).
Croatian: • Istodobno liječenje bilo kojim drugim antikoagulansom, npr. nefrakcioniranim heparinom, niskomolekularnim heparinima (enoksaparin, dalteparin i drugi), derivatima heparina (fondaparinuks i drugi), oralnim antikoagulansima (varfarin, dabigatran eteksilat, rivaroksaban, apiksaban i drugi) osim u specifičnim situacijama kad se mijenja oralna antikoagulacijska terapija (vidjeti dio 4.2) ili kad se nefrakcionirani heparin daje u dozama potrebnim za održavanje prohodnosti centralnog venskog ili arterijskog katetera (vidjeti dio 4.5).
English: Your doctor will need to do blood measurements and will instruct you when to start taking Roteas.
Croatian: Liječnik će Vam morati napraviti krvne pretrage i onda će Vam dati uputu kada da počnete uzimati Roteas.
English: The majority of edoxaban treated patients were Caucasians (69.6%) and Asians (21.0%), 3.8% were Black, 5.3% were categorised as Other race.
Croatian: Bolesnici liječeni edoksabanom većinom su bili bijelci (69,6%) i azijati (21,0%), 3,8% bili su crnci,
English: Concomitant use of edoxaban with quinidine, verapamil, or amiodarone does not require dose reduction based on clinical data (see section 4.2).
Croatian: Kod istovremene primjene edoksabana s kinidinom, verapamilom ili amiodaronom, na temelju kliničkih podataka, nije potrebno sniziti dozu (vidjeti dio 4.2).
English: Table 11: Bleeding Events in Hokusai-VTE Study - Safety Analysis On-Treatment Perioda
Croatian: Tablica 11: Događaji krvarenja u ispitivanju Hokusai-VTE - analiza sigurnosti primjene u razdoblju liječenjaa
English: Discontinuation for surgery and other interventions If anticoagulation must be discontinued to reduce the risk of bleeding with surgical or other procedures, Roteas should be stopped as soon as possible and preferably at least 24 hours before the procedure.
Croatian: Ako se antikoagulacija mora prekinuti da bi se smanjio rizik od krvarenja kod kirurških ili drugih postupaka, potrebno je čim prije prekinuti primjenu Roteasa, po mogućnosti najmanje 24 sata prije postupka.
English: Edoxaban should be used with caution when co-administered with P-gp inducers.
Croatian: Edoksaban se mora primjenjivati s oprezom kad se istodobno primjenjuju induktori P-gp-a.
English: PATIENT INFORMATION Patient name:
Croatian: Ime bolesnika:
English: • Bleeding in the eyes
Croatian: • krvarenje u oči
English: Chronic use of NSAIDs with edoxaban is not recommended.
Croatian: Kronična primjena NSAR-ova s edoksabanom se ne preporučuje.
English: Secondary efficacy outcomes included the composite clinical outcome of recurrent VTE and all-cause mortality.
Croatian: Sekundarni ishodi djelotvornosti uključili su kompozitni klinički ishod sastavljen od recidivirajućeg VTE-a i mortaliteta bilo kojeg uzroka.
English: Your doctor will decide, if you should be treated with Roteas and if you should be kept under observation.
Croatian: Vaš će liječnik odlučiti smijete li se liječiti Roteasom i morate li biti pod nadzorom.
English: Changing from Roteas to vitamin K antagonists (e.g. warfarin) If you currently take 60 mg Roteas:
Croatian: Zamjena lijeka Roteas antagonistima vitamina K (npr. varfarinom) Ako trenutno uzimate Roteas u dozi od 60 mg:
English: - prevent blood clots in the brain (stroke) and other blood vessels in the body if you have a form of irregular heart rhythm called nonvalvular atrial fibrillation and at least one additional risk factor.
Croatian: Roteas se primjenjuje u odraslih za: - sprječavanje nastanka krvnih ugrušaka u mozgu (moždani udar) i drugim krvnim žilama u tijelu ako imaju vrstu nepravilnog srčanog ritma koji se zove nevalvularna fibrilacija atrija i još barem jedan dodatni čimbenik rizika
English: 30 mg and 60 mg film-coated tablets:
Croatian: 30 mg i 60 mg filmom obložene tablete:
English: • antidepressant medicines called selective serotonin reuptake inhibitors or serotonin norepinephrine reuptake inhibitors
Croatian: • lijekove za liječenje depresije koji se nazivaju selektivni inhibitori ponovne pohrane serotonina ili inhibitori ponovne pohrane serotonina i noradrenalina.
English: A specific antidote antagonising the pharmacodynamic effect of edoxaban is not available.
Croatian: Specifični antidot za poništavanje farmakodinamičkih učinaka edoksabana nije dostupan.
English: Patients undergoing cardioversion:
Croatian: Bolesnici koji će biti podvrgnuti kardioverziji:
English: ≥ 30 to ≤ 50 1,302 96
Croatian: ≥ 30 do ≤ 50 1302 96
English: Roteas 15 mg is only to be used when changing from Roteas 30 mg to a vitamin K antagonist (e.g. warfarin) (see section 3.
Croatian: Roteas 15 mg smije se primjenjivati samo kad se Roteas 30 mg zamjenjuje antagonistom vitamina K (npr. varfarinom) (vidjeti dio 3.
English: Allergic oedema
Croatian: Alergijski edem
English: The primary efficacy endpoint was the recurrence of symptomatic VTE, defined as the composite of recurrent symptomatic DVT, non-fatal symptomatic PE and fatal PE in subjects during the 12-month study period.
Croatian: Primarni ishod djelotvornosti bio je recidiv simptomatskog VTE-a, definiran kao kompozitna mjera sastavljena od recidivirajućeg simptomatskog DVT-a, simptomatskog PE-a bez smrtnog ishoda i PE-a sa smrtnim ishodom u ispitanika tijekom 12-mjesečnog razdoblja ispitivanja.
English: • some medicines for treatment of epilepsy (e.g. phenytoin, carbamazepine, phenobarbital)
Croatian: • neke lijekove za liječenje epilepsije (npr. fenitoin, karbamazepin, fenobarbital)
English: Due to the high plasma protein binding edoxaban is not expected to be dialysable.
Croatian: Budući da se edoksaban u visokom postotku veže za proteine plazme, ne očekuje se da bi se mogao ukloniti dijalizom.
English: The t½ for oral administration is 10 - 14 hours.
Croatian: Kod oralne primjene, t½ iznosi od 10 do 14 sati.
English: Taking an anticoagulant medicine such as Roteas can increase your risk of bleeding.
Croatian: RIZIK OD KRVARENJA Uzimanje antikoagulantnog lijeka kao što je Roteas može Vam povećati rizik od krvarenja.
English: • Hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
Croatian: • Bolesnici s bolešću jetre udruženom s koagulopatijom i klinički značajnim rizikom od krvarenja.
English: The safety of edoxaban has been evaluated in two Phase 3 studies including 21,105 patients with NVAF (ENGAGE AF-TIMI 48 study), and 8,292 patients with VTE (DVT and PE) (Hokusai-VTE study).
Croatian: Sigurnost edoksabana procijenjena je u dva ispitivanja faze 3 koja su uključila 21 105 bolesnika s NVAF-om (ispitivanje ENGAGE AF-TIMI 48) te 8292 bolesnika s VTE-om (DVT i PE) (ispitivanje Hokusai-VTE).
English: HR (95% CI) All Bleeding n
Croatian: HR (95% CI) CRNM krvarenje n
English: The effect on prothrombin time (PT) and other coagulation biomarkers (e.g. anti-FXa, aPTT) was measured.
Croatian: Mjerio se učinak na protrombinsko vrijeme (PV) i druge biološke biljege koagulacije (npr. anti-FXa, aPTV).
English: These include acetylsalicylic acid (ASA), P2Y12 platelet inhibitors, other antithrombotic agents, fibrinolytic therapy, selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), and chronic nonsteroidal anti-inflammatory drugs (NSAIDs) (see section 4.5).
Croatian: Među njima su acetilsalicilatna kiselina (ASK), inhibitori trombocitnog receptora P2Y12, drugi antitrombotički lijekovi, fibrinolitička terapija, selektivni inhibitori ponovne pohrane serotonina (SSRI) i/ili inhibitori ponovne pohrane serotonina i noradrenalina (SNRI) i kronična primjena nesteroidnih protuupalnih lijekova (NSAR) (vidjeti dio 4.5).
English: • some medicines for fungal infections (e.g. ketoconazole)
Croatian: • neke lijekove protiv gljivičnih infekcija (npr. ketokonazol)