natgillin/translations-raw huggingface dataset:
Anaphylactic reaction 
Alergijska reakcija
The primary outcome (adjudicated major bleeding according to ISTH criteria) occurred in 5 (1.6 %) patients in the dabigatran etexilate group and 22 (6.9 %) patients in the warfarin group (risk difference −5.3%; 95% CI −8.4, −2.2; P=0.0009). 
Primarni ishod (pojavnost velikih krvarenja sukladno kriterijima ISTH) pojavio se u 5 (1,6%) bolesnika u skupini koja je primala dabigatraneteksilat te u 22 (6,9%) bolesnika u skupini koja je primala varfarin (razlika rizika - 5,3%; 95% CI - 8,4, -2,2; P=0,0009).
Treatment of blood clots in the veins of your legs and lungs including prevention of blood clots from re-occurring in the veins of your legs and/or lungs 
Liječenje krvnih ugrušaka u venama nogu i pluća uključujući prevenciju ponovne pojave krvnih ugrušaka u venama nogu i/ili pluća
Patients with mild and moderate renal impairment had at steady state an average 1.8-fold and 3.6-fold higher pre-dose dabigatran plasma concentrations compared with patients with CrCL > 80 mL/min, respectively. 
Bolesnici s blagim i umjerenim oštećenjem bubrega imali su, pri stanju ravnoteže, prosječno 1,8 puta odnosno 3,6 puta više koncentracije dabigatrana u plazmi prije doziranja, u usporedbi s bolesnicima s CrCL > 80 mL/min.
Table 11: Adverse reactions 
Tablica 11: Nuspojave
With chronic use in the RE-LY study, NSAIDs increased the risk of bleeding by approximately 50 % on both dabigatran etexilate and warfarin. 
Kronična primjena NSAIL-a u ispitivanju RE-LY povećala je rizik od krvarenja za oko 50 % i za dabigatran i varfarin.
Furthermore, concomitant use of antiplatelets, ASA or clopidogrel approximately doubled major bleeding rates with both dabigatran etexilate and warfarin (see section 4.4). 
Nadalje, istodobna primjena antitrombocitnih, acetilasalicilatne kiseline ili klopidogrela približno je udvostručila stopu velikih krvarenja i uz dabigatraneteksilat i varfarin (vidjeti dio 4.4).
Table 1: Dose recommendations and duration of therapy for primary prevention of venous thromboembolism in orthopaedic surgery 
Tablica 1: Preporučene doze i trajanje terapije kod primarne prevencije venske tromboembolije u ortopedskoj kirurgiji
Pradaxa should be restarted after the invasive procedure or surgical intervention as soon as possible provided the clinical situation allows and adequate haemostasis has been established. 
Primjena Pradaxe treba se ponovno započeti nakon invazivnog postupka ili kirurške intervencije čim je prije moguće uz uvjet da to dopušta klinička situacija i da je uspostavljena odgovarajuća hemostaza.
For situations of life-threatening or uncontrolled bleeding, when rapid reversal of the anticoagulation effect of dabigatran is required, the specific reversal agent (Praxbind, idarucizumab) is available (see section 4.9). 
U situacijama po život opasnog ili nekontroliranog krvarenja, kada je potrebno brzo poništenje antikoagulacijskog učinka dabigatrana, dostupan je specifičan antagonist (Praxbind, idrucizumab) (vidjeti dio 4.9).
Additionally, dabigatran exposure (at trough and peak) was assessed in a prospective open label randomized pharmacokinetic study in NVAF patients with severe renal impairment (defined as creatinine clearance [CrCl] 15-30 mL/min) receiving dabigatran etexilate 75 mg twice daily. 
Osim toga, izloženost dabigatranu (pri najnižoj i vršnoj koncentraciji) bila je procijenjena u prospektivnom, otvorenom, randomiziranom farmakokinetičkom ispitivanju u bolesnika s nevalvularnom fibrilacijom atrija (NVAF) i teškim oštećenjem bubrega (definiranim kao klirens kreatinina [CrCl] 15-30 ml/min) koji su primali dabigatraneteksilat u dozi od 75 mg dvaput dnevno.
Immune system disorder Drug hypersensitivity 
Poremećaji imunološkog sustava Preosjetljivost na lijek manje često
Clearance of dabigatran in patients with renal insufficiency may take longer (see section 5.2). 
Klirens dabigatrana u bolesnika s bubrežnom insuficijencijom može biti usporen (vidjeti dio 5.2).
Incidences (%) Hazard ratio over warfarin (95 % CI) p value superiority p=0.2721 
Incidencije (%) HR naspram varfarina (95 % CI) p-vrijednost superiornosti p=0,2721
The trials, demonstrated that treatment with dabigatran etexilate 150 mg twice daily was non-inferior to the treatment with warfarin ( non-inferiority margin for RE-COVER and RE-COVER II: 3.6 for risk difference and 2.75 for hazard ratio). 
Ispitivanja su pokazala da liječenje dabigatraneteksilatom 150 mg dvaput dnevno nije bilo inferiorno liječenju varfarinom (granica neinferiornosti za RE-COVER i RE-COVER II: 3,6 za razliku rizika i 2,75 za omjer hazarda).
Concomitant use contraindicated (see section 4.3) 
Istodobna primjena kontraindicirana (vidjeti dio 4.3) Ketokonazol
220 mg Pradaxa once daily taken as 2 capsules of 110 mg 
220 mg Pradaxe jedanput dnevno u obliku 2 kapsule od 110 mg
Table 20: Analysis of first occurrence of stroke or systemic embolism (primary endpoint) during the study period in RE-LY. 
Tablica 20: Analiza vremena do prve pojave moždanog udara ili sistemske embolije (primarni ishod) u RE-LY studiji.
Dose reductions are recommended for patients who receive concomitantly verapamil (see table 2 above and sections 4.4 and 4.5). 
Preporučuju se sniženja doze za bolesnike koji istodobno primaju verapamil (vidjeti tablicu 2 iznad i dio 4.4 i 4.5).
RE-MEDY demonstrated that treatment with dabigatran etexilate 150 mg twice daily was non-inferior to warfarin (non-inferiority margin: 2.85 for hazard ratio and 2.8 for risk difference). 
RE-MEDY je pokazao da liječenje dabigatraneteksilatom 150 mg dvaput dnevno nije bilo inferiorno varfarinu (granica neinferiornosti: 2,85 za omjer hazarda i 2,8 za razliku hazarda).
With chronic use, NSAIDs increased the risk of bleeding by approximately 50 % on both dabigatran etexilate and warfarin. 
Kronična primjena NSAIL-a povećala je rizik od krvarenja za oko 50 % i za dabigatran i varfarin.
Pradaxa 75 mg hard capsules are also available in polypropylene (plastic) bottles with 60 hard capsules. 
Pradaxa 75 mg tvrde kapsule također su dostupne u polipropilenskoj (plastičnoj) boci sa 60 tvrdih kapsula.
INFORMATION IN BRAILLE Pradaxa 110 mg 
16. PODACI NA BRAILLEOVOM PISMU Pradaxa 110 mg
The most commonly reported events are bleedings occurring in approximately 14 % of patients treated short-term for elective hip or knee replacement surgery, 16.6 % in patients with atrial fibrillation treated long-term for the prevention of stroke and systemic embolism, and in 14.4 % of patients treated for DVT/PE. 
Najčešće prijavljeni događaji su krvarenja koja su se pojavila u oko 14 % bolesnika liječenih kratkotrajno zbog elektivnog kirurškog zahvata ugradnje endoproteze kuka ili koljena, 16,6 % u bolesnika s fibirilacijom atrija dugotrajno liječenih radi prevencije moždanog udara i sistemske embolije, kao i 14,4% bolesnika liječenih zbog DVT/PE-a.
If you have a potentially higher risk for bleeding, your doctor may decide to prescribe a dose of Pradaxa 220 mg taken as one 110 mg capsule twice a day. 
Ako imate potencijalno veći rizik od krvarenja, liječnik odlučuje hoće li Vam propisati doze Pradaxe od 220 mg uzete u obliku jedne kapsule od 110 mg dvaput dnevno.
Table 8 shows the adverse reactions ranked under headings of System Organ Classes (SOC) and frequency using the following convention: very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100), rare ( 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data). 
Tablica 8 prikazuje nuspojave poredane prema klasifikaciji organskih sustava i učestalosti, uz sljedeću konvenciju: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nije poznato (ne može se utvrditi iz dostupnih podataka).
Injury, poisoning and procedural complications Traumatic haemorrhage 
Ozljede, trovanja i proceduralne komplikacije Krvarenje iz trauma manje često
The ECT was not measured in patients treated for prevention of VTEs after hip or knee replacement surgery with 220 mg dabigatran etexilate once daily. 
ECT nije mjeren kod bolesnika liječenih radi prevencije VTE-a nakon kirurškog zahvata ugradnje endoproteze kuka ili koljena s 220 mg dabigatraneteksilata jedanput dnevno.
Subjects randomized 
Randomizirani ispitanici
The point estimate for incidence of Major VTE and VTE related mortality for the 150 mg dose was slightly worse than enoxaparin (table 17). 
Točkovna procjena incidencije teškog VTE-a i smrtnosti povezane s VTE-om uz dozu od 150 mg bila je neznatno lošija nego uz enoksaparin (tablica 17).
Table 18: Hazard Ratio and 95 % CI for stroke/systemic embolism by subgroups 
Tablica 18: Omjer hazarda i 95 % CI za moždani udar/sistemske embolije po podskupinama
Capsules with white, opaque cap and white, opaque body of size 2 filled with yellowish pellets. 
Kapsule s bijelom, neprozirnom kapicom i bijelim, neprozirnim tijelom veličine 2, napunjene žućkastim peletima.
The point estimate for incidence of major VTE and VTE related mortality for the 150 mg dose was slightly worse than enoxaparin (table 10). 
Točkovna procjena incidencije teškog VTE-a i smrtnosti povezane s VTE-om uz dozu od 150 mg bila je neznatno lošija nego uz enoksaparin (tablica 10).
At the end of the follow-up VTE events in patients treated with dabigatran etexilate was 6.9 % vs. 10.7 % among the placebo group (hazard ratio 0.61 (95% CI 0.42, 0.88), p=0.0082). 
Na kraju praćenja stopa VTE događaja kod bolesnika liječenih dabigatraneteksilatom bila je 6,9 % naspram 10,7 % u skupini na placebu (omjer hazarda 0,61 (95% CI 0,42; 0,88), p =
Rare (may affect up to 1 in 1,000 people): - Bleeding - Bleeding may happen in the brain, from a surgical incision, from the site of entry of an injection or from the site of entry of a catheter into a vein 
Rijetke nuspojave (mogu se javiti u do 1 na 1 000 osoba): - Krvarenje može biti iz kirurškog reza, ili iz mjesta injektiranja, ili iz mjesta ulaska katetera u venu, ili iz mozga
Data for the major VTE and VTE-related mortality endpoint were homogeneous with regards to the primary efficacy endpoint and are shown in table 10. 
Podaci za teške VTE i mortalitet povezan s VTE-om bili su sukladni podacima za primarni ishod djelotvornosti te su prikazani u tablici 10.
Based on dabigatran concentrations as determined by the diluted thrombin time test and clinical assessment, the dose was adjusted to the target dose of 2.14 (± 10%) mg/kg bodyweight of dabigatran etexilate. 
Na osnovi koncentracija dabigatrana, prema testu kalibriranog razrijeđenog trombinskog vremena i kliničkoj ocjeni, doza je bila prilagođena ciljnoj dozi dabigatraneteksilata od 2,14 (± 10%) mg/kg tjelesne težine.
Dose reduction recommended Patients aged ≥80 years daily dose of 220 mg Pradaxa taken as one 110 mg capsule twice daily 
Preporučeno sniženje doze Bolesnici u dobi≥ 80 godina dnevna doza Pradaxe od 220 mg uzeta u obliku jedne kapsule od 110 mg dvaput dnevno
Although low in frequency in clinical trials, major or severe bleeding may occur and, regardless of location, may lead to disabling, life-threatening or even fatal outcomes. 
Iako rijetko po učestalosti u kliničkim ispitivanjima, može doći do velikog ili teškog krvarenja, koje, bez obzira na mjesto, može biti onesposobljavajuće, opasno po život, ili čak fatalno.
This staggered intake is the recommended administration for start of ticagrelor with a loading dose. 
Ovakav raspored doziranja tikagrelora s udarnom dozom preporučuje se za početak primjene.
Table 7: Other interactions 
Druge interakcije Tablica 7: Druge interakcije
th percentile of dabigatran plasma concentrations was 67 ng/mL, measured at trough (20-28 hours after the previous dose) (see section 4.4 and 4.9), 
• 90. percentila koncentracija dabigatrana u plazmi bila je 67 ng/mL, mjereno pri kraju dozirnog intervala (20-28 sati nakon prethodne doze) (vidjeti dijelove 4.4 i 4.9),
2 days before 
2 dana prije
No dose adjustment is necessary in patients with mild renal impairment (CrCL 50- ≤ 80 mL/min). 
Nije potrebno prilagođavanje doze za bolesnike s blagim oštećenjem bubrega (CrCL 50 - ≤ 80 mL/min).
For elderly patients > 75 years, a dose reduction is recommended (see table 1 above and sections 4.4 and 5.1). 
> 75 godina preporučuje se sniženje doze (vidjeti tablicu 1 iznad i dijelove 4.4 i
• The blister foil should only be peeled off, when a hard capsule is required. 
• Blister folija se smije odvojiti tek kada je potrebno uzeti kapsulu.
The rate of the combination of MBEs/CRBEs and the rate of any bleeding was significantly lower at a nominal alpha level of 5 % in patients receiving placebo as compared with those receiving Pradaxa. 
Stopa kombinacije MBE/CRBE-a i stopa svakog krvarenja bila je značajno niža na nominalnoj alfa-razini 5% kod bolesnika na placebu u usporedbi sa bolesnicima na Pradaxi.
INFORMATION IN BRAILLE Pradaxa 75 mg (only applicable for folding box, not applicable for bottle label) 
16. PODACI NA BRAILLEOVOM PISMU Pradaxa 75 mg (primjenjivo samo za kutiju, nije primjenjivo za naljepnicu na boci)
If you are taking amiodarone, quinidine or verapamil containing medicines the recommended dose is 150 mg once a day (taken as 2 capsules of 75 mg). 
Ako uzimate lijekove koji sadrže amiodaron, kinidin ili verapamil, preporučena doza je 150 mg jedanput dnevno (uzeta u obliku 2 kapsule od 75 mg).
The primary objective in this study was to determine if dabigatran etexilate was non-inferior to warfarin in reducing the occurrence of the composite endpoint stroke and systemic embolism. 
Primarni cilj ove studije bio je odrediti je li dabigatraneteksilat neinferioran varfarinu u odnosu na kompozitni ishod - incidencija moždanog udara i/ili sistemske embolije.
Pradaxa 150 mg are hard capsules with an opaque, light blue-coloured cap and an opaque, white body. 
Pradaxa 150 mg su tvrde kapsule s neprozirnom, svijetloplavom kapicom i neprozirnim, bijelim tijelom.
Table 11 shows the adverse reactions identified from studies and post-marketing data in the indications primary VTE prevention after hip or knee replacement surgery, prevention of thromboembolic stroke and systemic embolism in patients with atrial fibrillation, DVT/PE treatment and DVT/PE prevention. 
Tablica 11 prikazuje nuspojave identificirane iz podataka iz ispitivanja i razdoblja nakon stavljanja lijeka u promet za indikacije primarne prevencije VTE-a nakon kirurškog zahvata ugradnje endoproteze kuka ili koljena, prevencije tromboembolijskog moždanog udara i sistemske embolije u bolesnika s fibrilacijom atrija te liječenja DVT/PE-a i prevencije DVT/PE-a.
If you are taking amiodarone, quinidine or verapamil containing medicines, your doctor will tell you to use a reduced dose of Pradaxa. 
Ako uzimate lijekove koji sadrže amiodaron, kinidin ili verapamil, liječnik će Vam savjetovati da primijenite sniženu dozu Pradaxe.
Data for adjudicated major bleeding endpoints are shown in table 19 below. 
Podaci o pojavnosti velikih krvarenja prikazani su u tablici 19 u nastavku.
Multipack containing 2 packs of 50 x 1 hard capsules (100 hard capsules) in perforated aluminium unit dose blisters. 
Višestruko pakiranje koje sadrži 2 pakiranja s 50 x 1 tvrdom kapsulom (100 tvrdih kapsula) u perforiranim aluminijskim blisterima s jediničnim dozama.
Dose reductions are recommended for patients who receive concomitantly verapamil (see table 1 above and sections 4.4 and 4.5). 
Preporučuju se sniženja doze za bolesnike koji istodobno primaju verapamil (vidjeti tablicu 1 iznad i dijelove 4.4 i 4.5).
Nervous system disorders Intracranial haemorrhage 
Poremećaji živčanog sustava Intrakranijalno krvarenje rijetko
If you are 80 years or older, the recommended dose of Pradaxa is 220 mg taken as one 110 mg capsule twice a day. 
Ako imate 80 ili više godina starosti, preporučena doza Pradaxe je 220 mg uzete u obliku jedne kapsule od 110 mg dvaput dnevno.
-if you fall or injure yourself during treatment, especially if you hit your head.Please seek urgent medical attention. 
ako padnete ili se ozlijedite tijekom liječenja, posebice ako se udarite u glavu.
Test (trough value) 
Test (najniža vrijednost)
Patients at risk for bleeding or patients at risk of overexposure, notably patients with moderate renal impairment (CrCL 30-50 mL/min), should be treated with caution (see sections 4.4 and 5.1). 
Bolesnike s povećanim rizikom od krvarenja ili bolesnike s rizikom od prevelike izloženosti dabigatranu, osobito bolesnike s umjerenim oštećenjem bubrega (CrCL 30 - 50 mL/min) potrebno je liječiti s oprezom (vidjeti dijelove 4.4 i 5.1).
Precautions and management of the haemorrhagic risk For the management of bleeding complications, see also section 4.9. 
Za zbrinjavanje komplikacija krvarenja, vidjeti također dio 4.9.
Pradaxa should only be given if the benefit outweighs bleeding risks. 
Pradaxa se daje samo ako koristi nadilaze rizike od krvarenja.
Data for adjudicated major bleeding endpoints are shown in table 12 below. 
Podaci o pojavnosti velikih krvarenja prikazani su u tablici 12 u nastavku.
Gastroesophageal reflux disease 
Gastroezofagealna refluksna bolest rijetko
Table 5: Transporter interactions 
Tablica 5: Interakcije na razini transportnih mehanizama
Pradaxa 150 mg once daily 
Pradaxa 150 mg jedanput dnevno
Dialysis was conducted with 700 mL/min dialysate flow rate, four hour duration and a blood flow rate of either 200 mL/min or 350-390 mL/min. 
Dijaliza je provedena s brzinom protoka dijalizata od 700 mL/min, u trajanju četiri sata te sa stopom protoka krvi od ili 200 mL/min ili 350-390 mL/min.
INFORMATION IN BRAILLE Pradaxa 110 mg (only applicable for folding box, not applicable for bottle label) 
16. PODACI NA BRAILLEOVOM PISMU Pradaxa 110 mg (primjenjivo samo za kutiju, nije primjenjivo za naljepnicu na boci)
Blood and lymphatic system disorders Haemoglobin decreased 
Poremećaji krvi i limfnog sustava Sniženi hemoglobin često
Pradaxa treatment should be resumed / started after the invasive procedure or surgical intervention as soon as possible provided the clinical situation allows and adequate haemostasis has been established. 
Liječenje Pradaxom treba se nastaviti/započeti nakon invazivnog postupka ili kirurške intervencije čim je prije moguće uz uvjet da to dopušta klinička situacija i da je uspostavljena odgovarajuća hemostaza.
• 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, rivaroxaban, apixaban etc) except under specific circumstances. 
• Istovremeno liječenje drugim antikoagulansom, npr. nefrakcioniranim heparinom (UFH), niskomolekularnim heparinom (enoksaparin, dalteparin, itd), derivatima heparina (fondaparinuks, itd.), oralnim antikoagulansima (varfarin, rivaroksaban, apiksaban, itd.) osim u specifičnim okolnostima.
• the 90th percentile of aPTT at trough (10-16 hours after the previous dose) was 62 seconds, which would be 1.8-fold compared to baseline. 
• 90. percentila aPTT pri kraju dozirnog intervala (10 - 16 sati nakon prethodne doze) bila je 62 sekunde, što bi bilo 1,8 puta više u usporedbi s početnom vrijednošću.
While certain patient subgroups are at an increased risk of major bleeding when treated with an anticoagulant, the excess bleeding risk for dabigatran is due to GI bleeding, typically seen within the first 3-6 months following initiation of Pradaxa therapy. 
Dodatni rizik koji je posljedica primjene dabigatrana odnosi se na povećan rizik od gastrointestinalnog krvarenja koje se obično vidi unutar 3 - 6 mjeseci liječenja Pradaxom.
Pradaxa 110 mg are hard capsules with an opaque, light blue-coloured cap and an opaque, light blue -coloured body. 
Pradaxa 110 mg su tvrde kapsule s neprozirnom, svijetloplavom kapicom i neprozirnim tijelom svijetloplave boje.
Assessment of renal function prior to and during Pradaxa treatment In all patients and especially in the elderly (>75 years), as renal impairment may be frequent in this age group: 
U svih bolesnika, a osobito starijih osoba (u dobi >75 godina), jer oštećenje bubrega može biti često u toj dobnoj skupini:
When excessive dabigatran exposure is identified in patients at high risk of bleeding, a reduced dose of 220 mg taken as one 110 mg capsule twice daily is recommended. 
Kada se prekomjerna izloženost dabigatranu prepozna u bolesnika s visokim rizikom od krvarenja, preporučuje se snižena doza od 220 mg u obliku jedne kapsule od 110 mg dvaput dnevno.
4.7 Effects on ability to drive and use machines Pradaxa has no or negligible influence on the ability to drive and use machines. 
Pradaxa ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Pradaxa 110 mg hard capsules are also available in polypropylene (plastic) bottles with 60 hard capsules. 
Pradaxa 110 mg tvrde kapsule također su dostupne u polipropilenskoj (plastičnoj) boci sa60 tvrdih kapsula.
- Belly ache or stomach ache - Indigestion - Difficulty in swallowing - Fluid exiting a wound - Fluid exiting a wound after an operation 
- Probavne tegobe - Otežano gutanje - Tekućina koja izlazi iz rane - Tekućina koja izlazi iz rane nakon operacije
Pradaxa is available in packs containing 10 x 1, 30 x 1 or 60 x 1 capsules in aluminium perforated unit dose blisters. 
Pradaxa je dostupna u pakiranjima s 10 x 1, 30 x 1 ili 60 x 1 kapsula u aluminijskim perforiranim blisterima s jediničnim dozama.
Half-life is prolonged if renal function is impaired as shown in table 23. 
Poluvijek se produljuje ako je bubrežna funkcija oštećena sukladno prikazanom u tablici 23.
• Mild to moderate P-gp inhibitor co-medication (e.g. amiodarone, verapamil, quinidine and ticagrelor; see section 4.5) 
• istodobna primjena blagih do umjerenih P-gp inhibitora (npr. amiodarona, verapamila, kinidina i tikagrelora; vidjeti dio 4.5)
For patients randomized to warfarin, the mean percentage of time in therapeutic range (TTR) (INR 2-3) was 64.4 % (median TTR 67 %). 
Za bolesnike randomizirane na varfarin, aritmetička sredina postotka vremena u terapijskom rasponu (TTR) (INR 2-3) iznosila je 64,4 % (medijan TTR je iznosio 67 %).
RE-NOVATE (hip) Treated patients N Number of MBE N(%) RE-MODEL (knee) Treated patients N Number of MBE N(%) 
RE-NOVATE (kuk) Broj liječenih bolesnika Broj događaja velikih krvarenja N(%) RE-MODEL (koljeno) Broj liječenih bolesnika Broj događaja velikih krvarenja N(%)
Some bleeding events (MBEs/CRBEs; any bleeding) were significantly lower at a nominal alpha level of 5% in patients receiving Pradaxa as compared with those receiving warfarin. 
Pojedini događaji krvarenja (MBE-i/CRBE-i (engl. major bleeding events/clinically relevant bleeding events); svako krvarenje) bili su značajno manji na nominalnoj alfa-razini 5% kod bolesnika na Pradaxi u usporedbi sa bolesnicima koji su primali varfarin.
Pradaxa 110 mg twice daily 
Pradaxa 110 mg dvaput dnevno
• Patient Alert Cards 
• Kartice s upozorenjima za bolesnike
Prevention of brain or body vessel obstruction by blood clot formation developing after abnormal heart beats 
Prevencija začepljenja krvnih žila mozga ili tijela stvaranjem krvnih ugrušaka koji se stvaraju nakon nepravilnih otkucaja srca
Patients following elective hip replacement surgery 
Bolesnici nakon elektivnog kirurškog zahvata ugradnje endoproteze kuka
PHARMACEUTICAL FORM AND CONTENTS 10 x 1 hard capsule 
OBLIK I SADRŽAJ 10 x 1 tvrda kapsula
• Do not stop intake of Pradaxa 
• Ne prekidajte primjenu Pradaxe
INFORMATION IN BRAILLE Pradaxa 150 mg (only applicable for folding box, not applicable for bottle label) 
16. PODACI NA BRAILLEOVOM PISMU Pradaxa 150 mg (primjenjivo samo za kutiju, nije primjenjivo za naljepnicu na boci)
Carton containing 6 blister strips (60 x 1) in perforated aluminium unit dose white blisters. 
Kutija koja sadrži 6 blister stripova (60 x 1) u bijelim perforiranim aluminijskim blisterima s jediničnim dozama.
Prevention of blood clot formation after knee or hip replacement surgery 
Prevencija stvaranja krvnog ugruška nakon kirurškog zahvata ugradnje koljena ili kuka