FrancophonIA/ELRC3.0 huggingface dataset:
English: As protein binding is low, dabigatran can be dialysed; there is limited clinical experience to demonstrate the utility of this approach in clinical studies (see section 5.2).
Croatian: S obzirom da je vezanje na proteine nisko, dabigatran se može dijalizirati; kliničko iskustvo o učincima dijalize u slučaju predoziranja je ograničeno (vidjeti dio 5.2).
English: From the data collected in the phase III study RE-LY (see section 5.1) it was observed that the concomitant use of other oral or parenteral anticoagulants increases major bleeding rates with both dabigatran etexilate and warfarin by approximately 2.5-fold, mainly related to situations when switching from one anticoagulant to another (see section 4.3).
Croatian: Iz podataka prikupljenih u ispitivanju RE-LY faze III (vidjeti dio 5.1), primijećeno je da istodobna primjena drugih oralnih ili parenteralnih antikoagulansa povećava stopu velikih krvarenja i uz dabigatraneteksilat i uz varfarin za oko 2,5 puta, uglavnom u vezi sa situacijama kada se prelazi s liječenja jednim antikoagulansom na drugi (vidjeti dio 4.3).
English: Low (34-35 %) concentration independent binding of dabigatran to human plasma proteins was observed.
Croatian: Opažen je nizak (34 - 35 %), o koncentraciji neovisan, stupanj vezivanja dabigatrana za proteine ljudske plazme.
English: The calibrated quantitative diluted TT (dTT) test provides an estimation of dabigatran plasma concentration that can be compared to the expected dabigatran plasma concentrations.
Croatian: Kalibrirani kvantitativni razrijeđeni TV (dTV) test daje procjenu koncentracije dabigatrana u plazmi, koja se može usporediti s očekivanim koncentracijama dabigatrana u plazmi.
English: Pradaxa should be swallowed as a whole with a glass of water, to facilitate delivery to the stomach.
Croatian: Pradaxa se treba progutati kao cjelovita kapsula s čašom vode kako bi se olakšalo njezino dospijevanje do želuca.
English: If you are taking verapamil containing medicines and your kidney function is decreased by more than half, you should be treated with a reduced dose of 75 mg Pradaxa because your bleeding risk may be increased.
Croatian: Ako uzimate lijekove koji sadrže verapamil, a imate smanjenu bubrežnu funkciju za više od pola, morate se liječiti sniženom dozom od 75 mg Pradaxe jer postoji mogućnost povećanog rizika od krvarenja.
English: After discontinuation of study medication the effect was maintained until the end of the follow-up, indicating that the initial treatment effect of dabigatran etexilate was sustained.
Croatian: Nakon prekida primjene lijeka iz ispitivanja, učinak se održao do kraja razdoblja praćenja, što ukazuje da je učinak dabigatraneteksilata iz početnog liječenja bio zadržan.
English: If you stop taking Pradaxa
Croatian: Ako prestanete uzimati Pradaxu
English: In addition, dabigatran AUCτ,ss and Cmax,ss and the coagulation measures for dabigatran effect or the inhibition of platelet aggregation as measure of clopidogrel effect remained essentially unchanged comparing combined treatment and the respective mono-treatments.
Croatian: Nadalje, AUCτ,ss i Cmax,ss dabigatrana te koagulacijski testovi kao mjera učinka dabigatrana ili testovi inhibicije agregacije trombocita kao mjere učinka klopidogrela ostali su u osnovi nepromijenjeni uz kombinirano liječenje u odnosu na relevantnu monoterapiju.
English: Limited data is available in patients < 50 kg (see section 5.2).
Croatian: Podaci za bolesnike težine < 50 kg su ograničeni (vidjeti dio 5.2).
English: ® may need to be stopped in advance of surgical or other invasive procedures.
Croatian: ® možda se mora prekinuti prije kirurškog ili drugog invazivnog postupka.
English: The inducing effect was diminished resulting in dabigatran exposure close to the reference by day 7 after cessation of rifampicin treatment.
Croatian: Inducirajući učinak se smanjio, s posljedičnom izloženosti dabigatranu blizu referentne vrijednosti, do 7. dana nakon prestanka primjene rifampicina.
English: • Make sure to use the latest version
Croatian: • Ovu karticu imajte sa sobom u svakom trenutku • Budite sigurni da koristite najnoviju verziju
English: The parenteral anticoagulant should be discontinued and Pradaxa should be started 0-2 hours prior to the time that the next dose of the alternate therapy would be due, or at the time of discontinuation in case of continuous treatment (e.g. intravenous Unfractionated Heparin (UFH)) (see section 4.5).
Croatian: Potrebno je prekinuti primjenu parenteralnog antikoagulansa i započeti s Pradaxom 0-2 sata prije vremena predviđenog za sljedeću dozu dosadašnje terapije ili u trenutku prekida u slučaju kontinuiranog liječenja (npr. intravenski nefrakcionirani heparin (UFH)) (vidjeti dio 4.5).
English: Caution should be exercised when Pradaxa is co-administered with posaconazole.
Croatian: Potreban je oprez kada se Pradaxa primjenjuje istodobno s posakonazolom.
English: When taking Pradaxa capsules out of the blister pack, the following instructions should be followed:
Croatian: Prilikom uzimanja Pradaxa kapsule iz blister pakiranja, potrebno je držati se sljedećih uputa:
English: For the primary endpoint, stroke and systemic embolism, no subgroups (i.e., age, weight, gender, renal function, ethnicity, etc.) were identified with a different risk ratio compared to warfarin.
Croatian: Za primarni ishod djelotvornosti kod moždanog udara ili sistemske embolije nisu identificirane podskupine (tj. dob, težina, spol, bubrežna funkcija, etnička pripadnost, itd.) s različitim omjerom rizika u usporedbi s varfarinom.
English: Food does not affect the bioavailability of dabigatran etexilate but delays the time to peak plasma concentrations by 2 hours.
Croatian: Hrana ne utječe na bioraspoloživost dabigatraneteksilata, ali odgađa vrijeme do postizanja vršnih koncentracija u plazmi za 2 sata.
English: • Hepatic impairment or liver disease expected to have any impact on survival
Croatian: • Oštećenje ili bolest jetre koje bi moglo imati utjecaj na preživljenje
English: The primary endpoint was a combined endpoint of major bleeds based on ISTH definition or clinically relevant non-major bleeding event.
Croatian: Primarni ishod je bio kombiniran i uključivao je velika krvarenja na temelju definicije ISTH-a ili klinički značajan događaj ne-velikog krvarenja.
English: The effect was progressively decreased with administration of an extended release formulation (increase of Cmax by about 1.9-fold and AUC by about 1.7-fold) or administration of multiple doses of verapamil (increase of Cmax by about 1.6-fold and AUC by about 1.5-fold).
Croatian: Učinak se progresivno smanjio s primjenom formulacije s produljenim oslobađanjem (povećani Cmax za oko 1,9 puta i AUC za oko 1,7 puta) ili primjenom višestrukih doza verapamila (povećani Cmax za oko 1,6 puta i AUC za oko 1,5 puta).
English: If treatment is not started on the day of surgery then treatment should be initiated with 2 capsules once daily.
Croatian: Ukoliko se liječenje ne počinje provoditi na dan zahvata, tada ga je potrebno započeti s 2 kapsule jedanput dnevno.
English: Depending on the clinical situation appropriate supportive treatment, such as surgical haemostasis and blood volume replacement, should be undertaken at the prescriber's discretion.
Croatian: Ovisno o kliničkoj situaciji, potrebno je provesti suportivno liječenje, kao što su kirurška hemostaza ili nadoknada volumena krvi, prema odluci nadležnog liječnika.
English: The amount of substance cleared by dialysis is proportional to the blood flow rate up to a blood flow rate of 300 mL/min.
Croatian: Količina tvari koja se očisti dijalizom proporcionalna je brzini protoka krvi do brzine protoka od 300 mL/min.
English: In the RE-SONATE study, which compared dabigatran etexilate to placebo, the rate of MI was 0.1% for patients who received dabigatran etexilate and 0.2% for patients who received placebo
Croatian: U ispitivanju RE-SONATE, koje je uspoređivalo dabigatraneteksilat s placebom, stopa IM-a je iznosila 0,1% za bolesnike koji su primali dabigatraneteksilat i 0,2% za bolesnike koji su primali placebo.
English: Renal function (CrCL in mL/min)
Croatian: Bubrežna funkcija (CrCL u mL/min)
English: After switching from 3-day treatment of once daily 40 mg enoxaparin s.c., 24 hours after the last dose of enoxaparin the exposure to dabigatran was slightly lower than that after administration of dabigatran etexilate (single dose of 220 mg) alone.
Croatian: Nakon prijelaza s 3-dnevnog liječenja enoksaparinom 40 mg/dan s.c., 24 sata nakon posljednje doze enoksaparina, izloženost dabigatranu bila je malo niža nego nakon primjene samog dabigatraneteksilata (jednokratna doza od 220 mg).
English: ® can be taken with or without food.
Croatian: ® se može uzimati sa ili bez hrane.
English: Two randomized, parallel group, double-blind studies were performed in patients previously treated with anticoagulation therapy.
Croatian: Dva randomizirana, dvostruko slijepa ispitivanja paralelnih skupina provedena su na bolesnicima koji su prethodno bili liječeni antikoagulacijskom terapijom.
English: If you are a woman of child-bearing age, you should avoid becoming pregnant while you are taking Pradaxa.
Croatian: Ako ste žena reproduktivne dobi, trebate izbjegavati trudnoću dok uzimate Pradaxu.
English: • Prosthetic heart valves requiring anticoagulant treatment (see section 5.1).
Croatian: • Umjetni srčani zalisci koji zahtijevaju liječenje antikoagulansom (vidjeti dio 5.1).
English: After oral administration, dabigatran etexilate is rapidly absorbed and converted to dabigatran by esterase-catalysed hydrolysis in plasma and in the liver.
Croatian: Nakon peroralne primjene, dabigatraneteksilat se brzo apsorbira i pretvara u dabigatran putem hidrolize katalizirane esterazom u plazmi i u jetri.
English: Not known (frequency cannot be estimated from the available data): - Difficulty in breathing or wheezing - Hair loss
Croatian: Nije poznato (učestalost se ne može procijeniti iz dostupnih podataka): - Problemi s disanjem ili piskanje - Gubitak kose
English: Pharmacodynamic interactions (see section 4.5) • ASA and other platelet aggregation inhibitors such as clopidogrel
Croatian: Farmakodinamičke interakcije (vidjeti dio 4.5) • acetilsalicilatna kiselina i drugi inhibitori agregacije trombocita poput klopidogrela
English: Concomitant administration of P-gp inducers is expected to result in decreased dabigatran plasma concentrations, and should be avoided (see sections 4.5 and 5.2).
Croatian: Smatra se da istodobna primjena induktora P-gp rezultira sniženim koncentracijama dabigatrana u plazmi te ju je potrebno izbjegavati (vidjeti dijelove 4.5 i 5.2).
English: SPECIAL STORAGE CONDITIONS Keep the bottle tightly closed.
Croatian: POSEBNE MJERE ČUVANJA Čuvati bocu čvrsto zatvorenu.
English: Dose reduction
Croatian: Sniženje doze
English: In the RE-MODEL trial (knee replacement) treatment was for 6-10 days and in the RE-NOVATE trial (hip replacement) for 28-35 days.
Croatian: U ispitivanju pod nazivom RE-MODEL (ugradnja endoproteze koljena) liječenje je trajalo 6 - 10 dana, a u ispitivanju pod nazivom RE-NOVATE (ugradnja endoproteze kuka) 28 - 35 dana.
English: When the calibrated dTT assay delivers a dabigatran plasma concentration result at or below the limit of quantification, an additional coagulation assay such as TT, ECT or aPTT should be considered.
Croatian: Kada je rezultat koncentracija dabigatrana u plazmi kalibriranog dTV testa jednak ili ispod granice kvantifikacije, potrebno je razmotriti provedbu dodatnog testa koagulacije kao što je TV, ECT ili aPTV.
English: A phase II study examined dabigatran etexilate and warfarin in a total of 252 patients with recent mechanical valve replacement surgery (i.e. within the current hospital stay) and in patients who received a mechanical heart valve replacement more than three months ago.
Croatian: U ispitivanju faze II, dabigatraneteksilat i varfarin ispitani su na ukupno 252 bolesnika koji su bili nedavno podvrgnuti kirurškom zahvatu ugradnje mehaničkog zaliska (tj. u sklopu aktualne hospitalizacije) kao i u bolesnika koji su prošli postupak ugradnje mehaničkog srčanog zaliska prije više od tri mjeseca.
English: Major bleeding rates with this dose were comparable to warfarin.
Croatian: Stopa velikog krvarenja uz ovu dozu bila je usporediva s varfarinom.
English: There is no relevant use of Pradaxa in the paediatric population for the indication of prevention of stroke and systemic embolism in patients with NVAF.
Croatian: Nije opravdana primjena Pradaxe u pedijatrijskoj populaciji za indikaciju prevencije moždanog udara i sistemske embolije u bolesnika s NVAF-om.
English: Table 9: Number of patients studied, maximum daily dose in phase III studies Indication
Croatian: Tablica 9: Broj ispitanih bolesnika, maksimalna dnevna doza u ispitivanjima faze III Indikacija
English: More thromboembolic events (mainly strokes and symptomatic/asymptomatic prosthetic valve thrombosis) and more bleeding events were observed with dabigatran etexilate than with warfarin.
Croatian: Primijećeno je više slučajeva tromboembolijskih događaja (uglavnom moždani udari i simptomatska/asimptomatska tromboza umjetnog zaliska) te više događaja krvarenja uz dabigatraneteksilat nego uz varfarin.
English: Direct acting Oral Anticoagulants (DOACs) including dabigatran etexilate 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 dabigatraneteksilat, ne preporučuju se bolesnicima koji u anamnezi imaju trombozu a dijagnosticiran im je antifosfolipidni sindrom.
English: Pradaxa is dialyzable.
Croatian: Pradaxa® se može dijalizirati.
English: Dosing should be reduced as indicated in table 1 (see also sections 4.4 and 4.5).
Croatian: Dozu je potrebno sniziti kako je prikazano u tablici 1 (vidjeti također dijelove 4.4 i 4.5).
English: Other patients at increased risk of bleeding
Croatian: Drugi bolesnici pod povećanim rizikom od krvarenja
English: Percutaneous coronary intervention (PCI) with stenting (SPAF) Patients with non valvular atrial fibrillation who undergo a PCI with stenting can be treated with Pradaxa in combination with antiplatelets after haemostasis is achieved (see section 5.1).
Croatian: Perkutana koronarna intervencija (PCI) s ugradnjom stenta (prevencija MU i SE kod AF) Bolesnici s nevalvularnom fibrilacijom atrija koji su podvrgnuti zahvatu PCI s ugradnjom stenta mogu se liječiti Pradaxom u kombinaciji s antitrombocitnim lijekovima nakon što se postigne hemostaza (vidjeti dio 5.1).
English: 95 % confidence interval Symptomatic DVT 95 % confidence interval Symptomatic PE
Croatian: Interval pouzdanosti 95 % Simptomatski DVT Interval pouzdanosti 95 % Simptomatski PE
English: You can continue to take Pradaxa if your heart beat needs to be restored to normal by a procedure called cardioversion or by a procedure called catheter ablation for atrial fibrillation.
Croatian: Možete nastaviti s uzimanjem Pradaxe ako je potrebno uspostaviti pravilne otkucaje srca postupkom koji se zove kardioverzija ili postupkom koji se zove kateterska ablacija radi fibrilacije atrija.
English: Prevention of blood clot formation after knee or hip replacement surgery Continue with your remaining daily doses of Pradaxa at the same time of the next day.
Croatian: Sprječavanje stvaranja krvnih ugrušaka nakon kirurškog zahvata ugradnje endoproteze koljena ili kuka Nastavite s preostalim dnevnim dozama Pradaxe u isto vrijeme sljedećeg dana.
English: glomerular filtration rate (CrCL,) [mL/min]
Croatian: Brzina glomerularne filtracije (CrCL,) [mL/min]
English: 300 mg Pradaxa taken as one 150 mg capsule twice daily following treatment with a parenteral anticoagulant for at least 5 days
Croatian: 300 mg Pradaxe uzeta u obliku jedne kapsule od 150 mg dvaput dnevno nakon liječenja parenteralnim antikoagulansom u trajanju od najmanje 5 dana
English: Alanine aminotransferase increased
Croatian: Povišena alanin-aminotransferaza manje često
English: In a small number of volunteers with severe renal insufficiency (CrCL 10-30 mL/min), the exposure (AUC) to dabigatran was approximately 6 times higher and the half-life approximately 2 times longer than that observed in a population without renal insufficiency (see sections 4.2, 4.3 and 4.4).
Croatian: U malog broja dobrovoljaca s teškom renalnim insuficijencijom (CrCL 10 - 30 mL/min), izloženost (AUC) dabigatranu bila je oko 6 puta veća, a poluvijek je bio oko 2 puta dulji nego u populaciji bez insuficijencije bubrega (vidjeti dijelove 4.2, 4.3 i 4.4).
English: The International Normalised Ratio (INR) test is unreliable in patients on Pradaxa and false positive INR elevations have been reported.
Croatian: Test za internacionalni normalizirani omjer (INR) je nepouzdan za bolesnike na Pradaxi i prijavljivani su lažno pozitivni porasti INR-a.
English: You can continue to take Pradaxa if your heart beat needs to be restored to normal by a procedure called cardioversion.
Croatian: Možete nastaviti s uzimanjem Pradaxe ako je potrebno uspostaviti pravilne otkucaje srca postupkom koji se zove kardioverzija.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Swallow whole, do not chew or break the capsule.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Kapsulu progutati cijelu, ne žvakati niti lomiti.
English: UFH can be administered at doses necessary to maintain a patent central venous or arterial catheter or during catheter ablation for atrial fibrillation (see section 4.3).
Croatian: UFH se može primjenjivati u dozama potrebnim za održavanje prohodnosti središnjeg venskog ili arterijskog katetera ili tijekom kateterske ablacije radi fibrilacije atrija (vidjeti dio 4.3).
English: Pradaxa doses beyond those recommended expose the patient to increased risk of bleeding.
Croatian: Doze Pradaxe iznad preporučenih izlažu bolesnika povećanom riziku od krvarenja.
English: Therefore, surgical interventions may require the temporary discontinuation of Pradaxa.
Croatian: Stoga, kirurške intervencije mogu zahtijevati privremeni prekid primjene Pradaxe.
English: Clopidogrel In young healthy male volunteers, the concomitant administration of dabigatran etexilate and clopidogrel resulted in no further prolongation of capillary bleeding times compared to clopidogrel monotherapy.
Croatian: U mladih zdravih muških dobrovoljaca, istodobna primjena dabigatraneteksilata i klopidogrela nije rezultirala dodatnim produljenjem vremena kapilarnog krvarenja u usporedbi s monoterapijom klopidogrelom.
English: No imbalance in the rate of heart attacks was observed in patients treated with dabigatran versus patients treated with placebo.
Croatian: Nema odstupanja u stopi srčanih udara zabilježenih u bolesnika liječenih dabigatranom u odnosu na bolesnike koji su primali placebo.
English: e.g. rifampicin, St. John´s wort (Hypericum perforatum), carbamazepine, or phenytoin
Croatian: npr. rifampicin, gospina trava (Hypericum perforatum), karbamazepin ili fenitoin
English: A missed dose should be omitted if the remaining time is below 6 hours prior to the next due dose.
Croatian: Propuštenu dozu treba preskočiti ako je preostalo vrijeme do sljedeće doze kraće od 6 sati.
English: This study demonstrated that dual-therapy with dabigatran etexilate and a P2Y12 antagonist significantly reduced the risk of bleeding vs. warfarin triple-therapy with non-inferiority for composite of thromboembolic events in patients with atrial fibrillation who underwent a PCI with stenting.
Croatian: Ovo je ispitivanje pokazalo da je dvojna terapija dabigatraneteksilatom i antagonistom receptora P2Y12 značajno snizila rizik od krvarenja naspram trojne terapije varfarinom uz neinferiornost za kompozitni ishod u tromboembolijskim događajima kod bolesnika s fibrilacijom atrija koji su bili podvrgnuti zahvatu PCI s ugradnjom stenta.
English: If a medical device (stent) has been deployed in a blood vessel to keep it open in a procedure called percutaneous coronary intervention with stenting, you can be treated with Pradaxa after your physician has decided that normal control of blood coagulation is achieved.
Croatian: Ako je postupkom perkutane koronarne intervencije (s ugradnjom stenta) zbog održavanja prohodnosti krvne žile u nju ugrađen medicinski proizvod (stent), možete biti liječeni lijekom Pradaxa nakon što Vaš liječnik zaključi da je postignuta normalna kontrola zgrušavanja krvi.
English: - if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed.
Croatian: - ako znate da imate bolest koja se naziva antifosfolipidni sindrom (poremećaj imunološkog sustava koji uzrokuje povećani rizik od nastanka krvnih ugrušaka), obavijestite o tome svog liječnika koji će odlučiti postoji li potreba za izmjenom terapije.
English: • Esophagitis, gastritis or gastroesophageal reflux
Croatian: • ezofagitis, gastritis ili gastroezofagealni refluks
English: • The backing foil should be peeled off and the capsule can be removed.
Croatian: • Stražnju foliju je potrebno odvojiti te se kapsula može izvaditi.
English: In the three active controlled DVT/PE phase III studies, a higher rate of MI was reported in patients who received dabigatran etexilate than in those who received warfarin: 0.4% vs. 0.2% in the shortterm RE-COVER and RE-COVER II studies; and 0.8% vs. 0.1% in the long-term RE-MEDY trial.
Croatian: U trima aktivno kontroliranim ispitivanjima DVT/PE faze III prijavljena je viša stopa IM-a za bolesnike koji su primali dabigatraneteksilat nego za osobe koje su primale varfarin: 0,4% naspram 0,2% u kratkotrajnim ispitivanjima RE-COVER i RE-COVER II; te 0,8% naspram 0,1% u dugotrajnom ispitivanju RE-MEDY.
English: In this case Pradaxa will need to be stopped temporarily due to an increased bleeding risk during and shortly after an operation.It is very important to take Pradaxa before and after the operation exactly at the times you have been told by your doctor.
Croatian: U tom slučaju, primjenu Pradaxe potrebno je privremeno prekinuti zbog povećanog rizika od krvarenja tijekom ili kratko nakon operacije.Veoma je važno uzeti Pradaxu prije i nakon operacije točno u vrijeme kada Vam je liječnik rekao da je uzmete.
English: Dabigatran is subject to conjugation forming pharmacologically active acylglucuronides.
Croatian: Dabigatran je podložan konjugaciji kojom nastaju farmakološki aktivni acilglukuronidi.
English: Aspartate aminotransferase increased
Croatian: Povišena aspartat-aminotransferaza manje često
English: Concomitant administration is expected to result in decreased dabigatran concentrations.
Croatian: Smatra se da istodobna primjena rezultira smanjenjem koncentracije dabigatrana.
English: There are no data available for 110 mg twice daily Pradaxa treatment in patients undergoing catheter ablation for atrial fibrillation (see section 4.2).
Croatian: Nema dostupnih podataka za liječenje Pradaxom 110 mg dvaput dnevno u bolesnika podvrgnutih kateterskoj ablaciji radi fibrilacije atrija (vidjeti dio 4.2).
English: All patients received an initial oral dose of 1.71 (± 10%) mg/kg of dabigatran etexilate (80 % of the adult dose of 150 mg/70 kg adjusted for the patient's weight).
Croatian: Svi bolesnici primili su početnu peroralnu dozu od 1,71 (± 10%) mg/kg dabigatraneteksilata (80 % doze za odrasle od 150 mg/70 kg prilagođeno bolesnikovoj težini).
English: Surgery and interventions
Croatian: Kirurški zahvati i intervencije
English: Patients who receive concomitant verapamil Dose reduction for consideration Patients between 75-80 years daily dose of Pradaxa of 300 mg or 220 mg should be selected based on an individual assessment of the thromboembolic risk and the risk of bleeding
Croatian: Razmotriti sniženje doze Bolesnici između 75-80 godina dnevna doza Pradaxe od 300 mg ili 220 mg odabire se na osnovi individualne ocjene rizika od tromboembolije i krvarenja
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 March 2008
Croatian: Datum prvog odobrenja: 18. ožujka 2008.
English: P-gp inducers
Croatian: P-gp induktori
English: If you forget to take Pradaxa
Croatian: Ako ste zaboravili uzeti Pradaxu