FrancophonIA/ELRC3.0 huggingface dataset:
English: clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid) - Medicines to treat fungal infections (e.g. ketoconazole, itraconazole), unless they are only applied to the skin - Medicines to treat abnormal heart beats (e.g. amiodarone, dronedarone, quinidine, verapamil).
Croatian: lijekovi koji sprječavaju stvaranje krvnih ugrušaka (npr. varfarin, fenprokumon, acenokumarol, heparin, klopidogrel, prasugrel, tikagrelor, rivaroksaban, acetilsalicilatna kiselina) lijekovi za liječenje gljivičnih infekcija (npr. ketokonazol, itrakonazol), osim ako se samo nanose na kožu lijekovi za liječenje abnormalnih otkucaja srca (npr. amiodaron, dronedaron, kinidin, verapamil).
English: Rare Injury, poisoning and procedural complications Traumatic haemorrhage
Croatian: Krvavi iscjedak rijetko Ozljede, trovanja i proceduralne komplikacije Krvarenje iz traume manje često rijetko manje često
English: The incidence of the primary endpoint was 15.4 % (151 patients) in the dabigatran etexilate 110 mg dual-therapy group as compared with 26.9 % (264 patients) in the warfarin triple-therapy group (HR 0.52; 95% CI 0.42, 0.63; P<0.0001 for non-inferiority and P<0.0001 for superiority) and 20.2 % (154 patients) in the dabigatran etexilate 150 mg dual-therapy group as compared with 25.7 % (196 patients) in the corresponding warfarin triple-therapy group (HR 0.72; 95% CI 0.58, 0.88; P<0.0001 for non-inferiority and P=0.002 for superiority).
Croatian: Incidencija primarne mjere ishoda je bila 15,4% (151 bolesnik) u skupini koja je primala dvojnu terapiju dabigatraneteksilatom 110 mg u usporedbi s 26,9% (264 bolesnika) u skupini koja je primala trojnu terapiju varfarinom (HR 0,52; 95% CI 0,42; 0,63; P<0,0001 za neinferiornost i P<0,0001 za superiornost) te 20,2% (154 bolesnika) u skupini koja je primala dvojnu terapiju dabigatraneteksilatom 150 mg u usporedbi s 25,7% (196 bolesnika) u odgovarajućoj skupini koja je primala trojnu terapiju varfarinom (HR 0,72; 95% CI 0,58; 0,88; P<0,0001 za neinferiornost i P=0,002 za superiornost).
English: The use of fibrinolytic medicinal products for the treatment of acute ischemic stroke may be considered if the patient presents with a dTT, ECT or aPTT not exceeding the upper limit of normal (ULN) according to the local reference range.
Croatian: Primjena fibrinolitika u liječenju akutnog ishemijskog moždanog udara može se razmatrati ako dTV, ECT, ili aPTV bolesnika ne prelaze gornju granicu normale (GGN), prema referentnom lokalnom rasponu.
English: - Medicines to prevent organ rejection after transplantation (e.g. tacrolimus, cyclosporine) - A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C) - Anti-inflammatory and pain reliever medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac) - St. John´s wort, a herbal medicine for depression - Antidepressant medicines called selective serotonin re-uptake inhibitors or serotonin norepinephrine re-uptake inhibitors - Rifampicin or clarithromycin (two antibiotics) - Anti-viral medicines for AIDS (e.g. ritonavir) - Certain medicines for treatment of epilepsy (e.g. carbamazepine, phenytoin)
Croatian: Pogledajte dio 3. lijekovi za sprječavanje odbacivanja organa nakon transplantacije (npr. takrolimus, ciklosporin) kombinirani lijek koji sadrži glekaprevir i pibrentasvir (antivirusni lijek koji se primjenjuje za liječenje hepatitisa C) protuupalni lijekovi i lijekovi protiv bolova (npr. acetilsalicilatna kiselina, ibuprofen, diklofenak) gospina trava, biljni lijek protiv depresije antidepresivikoji se nazivaju selektivni inhibitori ponovne pohrane serotonina ili inhibitori ponovne pohrane serotonina-noradrenalina rifampicin ili klaritromicin (dva antibiotika) antivirusni lijekovi za liječenje AIDS-a (npr. ritonavir) određeni lijekovi za liječenje epilepsije (npr. karbamazepin, fenitoin)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOLDING BOX FOR BLISTER for 75 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA BLISTER za 75 mg
English: Patients with moderate renal impairment (CrCL between 30-50 mL/min) had on average 2.29-fold and 1.81-fold higher pre- and post-dose dabigatran plasma concentrations, respectively, when compared with patients without renal impairment (CrCL ≥ 80 mL/min).
Croatian: Bolesnici s umjerenim oštećenjem bubrega (CrCL između 30-50 mL/min) imali su prosječno 2,29 puta i 1,81 puta više koncentacije dabigatrana u plazmi prije i poslije doziranja u usporedbi s bolesnicima bez oštećenja bubrega (CrCL ≥ 80 mL/min).
English: For treatment of DVT and PE, with dabigatran etexilate 150 mg twice daily,
Croatian: Za liječenje DVT-a i PE-a dabigatraneteksilatom 150 mg dvaput dnevno,
English: Table 6: Transporter interactions
Croatian: Tablica 6: Interakcije na razini transportnih mehanizama
English: RE-NOVATE (hip) Treated patients N Number of MBE N(%)
Croatian: RE-NOVATE (kuk) Broj liječenih bolesnika Broj velikih krvarenja N(%)
English: Quinidine was given as 200 mg dose every 2nd hour up to a total dose of 1,000 mg. Dabigatran etexilate was given twice daily over 3 consecutive days, on the 3
Croatian: Kinidin je davan u obliku 200 mg doze svaki drugi sat do ukupne doze od 1000 mg.
English: Incidences (%) Risk ratio over enoxaparin 95 % CI
Croatian: Incidencija (%) Omjer hazarda u odnosu na enoksaparin 95% CI
English: Table 7: Transporter interactions
Croatian: Tablica 7: Interakcije na razini transportnih mehanizama
English: The incidence of the composite efficacy endpoint of death, thromboembolic events (myocardial infarction, stroke, or systemic embolism) or unplanned revascularization in the two dabigatran etexilate dual-therapy groups combined was non-inferior to the warfarin triple-therapy group (13.7% vs. 13.4% respectively; HR 1.04; 95% CI: 0.84, 1.29; P=0.0047 for non-inferiority).There were no statistical differences in the individual components of the efficacy endpoints between either dabigatran etexilate dual-therapy groups and warfarin triple-therapy.
Croatian: Incidencija smrti, tromboembolijskih događaja (infarkt miokarda, moždani udar ili sistemska embolija) ili neplanirane revaskularizacije kao mjere kompozitnog ishoda djelotvornosti u združene dvije skupine koje su primale dvojnu terapiju dabigatraneteksilatom bila je neinferiorna onoj u skupini koja je primala trojnu terapiju varfarinom (13,7% naspram 13,4%; HR 1,04; 95% CI: 0,84; 1,29; P=0,0047 za neinferiornost).
English: Subjects randomized to 110 mg Pradaxa twice daily had a significantly lower risk for major bleeds compared with warfarin (hazard ratio 0.81 [p=0.0027]).
Croatian: Bolesnici randomizirani na liječenje Pradaxom 110 mg dvaput dnevno imali su značajno niži rizik od velikih krvarenja u usporedbi s varfarinom (relativni rizik 0,81 [p = 0,0027]).
English: Concomitant administration of P-gp inhibitors (see table 7) is expected to result in increased dabigatran plasma concentrations.
Croatian: Smatra se da istodobna primjena P-gp inhibitora (vidjeti tablicu 7) rezultira povećanim koncentracijama dabigatrana u plazmi.
English: Close clinical surveillance Close observation for signs of bleeding or anaemia is recommended throughout the treatment period, especially if risk factors are combined (see table 3 above).
Croatian: Preporučuje se pomno promatranje zbog znakova krvarenja ili anemije tijekom liječenja, osobito u slučaju kombinacije rizičnih faktora (vidjeti tablicu 3 gore).
English: Close observation for signs of bleeding or anaemia is recommended throughout the treatment period, especially if risk factors are combined (see table 2 above).
Croatian: Preporučuje se pomno promatranje zbog znakova krvarenja ili anemije tijekom liječenja, osobito u slučaju kombinacije rizičnih faktora (vidjeti tablicu 2 gore).
English: When rapid reversal of the anticoagulation effect is required the specific reversal agent (Praxbind, idarucizumab) to Pradaxa is available.
Croatian: U slučajevima kada je potrebno brzo poništenje antikoagulacijskog učinka, dostupan je specifičan antagonist za Pradaxu (Praxbind, idarucizumab).
English: Dabigatran etexilate has not been clinically studied together with tacrolimus.
Croatian: Dabigatraneteksilat nije klinički ispitivan u kombinaciji s takrolimusom.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 75 mg of dabigatran etexilate (as mesilate).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tvrda kapsula sadrži 75 mg dabigatraneteksilata (u obliku dabigatraneteksilatmesilata).
English: Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors (SPAF)
Croatian: Prevencija moždanog udara i sistemske embolije kod odraslih bolesnika s nevalvularnom fibrilacijom atrija s jednim ili više rizičnih faktora (prevecija MU i SE kod AF)
English: Swallow whole, do not chew or break the capsule.
Croatian: Kapsulu progutati cijelu, ne žvakati niti lomiti.
English: Age ≥ 75 years
Croatian: Bolesnici u dobi od 75 godina ili stariji
English: Close clinical surveillance Close observation for signs of bleeding or anaemia is recommended throughout the treatment period, especially if risk factors are combined (see table 4 above).
Croatian: Preporučuje se pomno promatranje zbog znakova krvarenja ili anemije tijekom liječenja, osobito u slučaju kombinacije rizičnih faktora (vidjeti tablicu 4 gore).
English: 22.9 % and 22.5 % of the patients had a CrCL > 50-< 80 mL/min, and 4.1 % and 4.8 % had a CrCL between 30 and 50 mL/min in the RE-MEDY and RE-SONATE studies.
Croatian: Medijani CrCL u ispitivanjima RE-MEDY i RE-SONATE bili su 99,0 mL/min odnosno 99,7 mL/min, 22,9 % i 22,5 % bolesnika imalo je CrCL > 50-< 80 mL/min, a 4,1 % i 4,8 % imalo je CrCL između 30 i 50 mL/min u ispitivanjima RE-MEDY i RE-SONATE.
English: Table 13: Bleeding events in a study testing the prevention of thromboembolic stroke and systemic embolism in patients with atrial fibrillation
Croatian: Tablica 13: Događaji krvarenja u studiji prevencije tromboembolijskog moždanog udara i sistemske embolije u bolesnika s fibrilacijom atrija
English: Because Pradaxa can impact the International Normalized Ratio (INR), the INR will better reflect VKA's effect only after Pradaxa has been stopped for at least 2 days.
Croatian: • CrCL ≥ 30 -< 50 mL/min, s primjenom VKA treba započeti 2 dana prije prekida Pradaxe Budući da Pradaxa može utjecati na vrijednosti internacionalnog normaliziranog omjera (INR), INR će bolje odražavati učinak VKA tek nakon što je prošlo najmanje 2 dana nakon prekida primjene Pradaxe.
English: Cardioversion (SPAF)
Croatian: Kardioverzija (prevencija MU i SE kod AF)
English: The table 11 shows bleeding events broken down to major and any bleeding in the pivotal study testing the prevention of thromboembolic stroke and systemic embolism in patients with atrial fibrillation.
Croatian: Tablica 11 pokazuje incidenciju krvarenja kategoriziranih na velika ili bilo kakva krvarenja u ključnoj studiji prevencije tromboembolijskog moždanog udara i sistemske embolije u bolesnika s fibrilacijom atrija.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOLDING BOX FOR BLISTER for 110 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA BLISTER za 110 mg
English: Life-threatening bleed
Croatian: Po život opasno krvarenje
English: The objective of the RE-MEDY study was to compare the safety and efficacy of oral dabigatran etexilate (150 mg bid) to warfarin (target INR 2.0-3.0) for the long-term treatment and prevention of recurrent, symptomatic DVT and/or PE. A total of 2,866 patients were randomized and 2,856 patients were treated.
Croatian: Cilj isptivanja RE-MEDY bio je usporediti sigurnost i učinkovitost oralnog dabigatraneteksilata (150 mg dvaput dnevno) s varfarinom (ciljni INR 2,0 - 3,0) u dugotrajnom liječenju i prevenciji rekurentnog, simptomatskog DVT-a i/ili PE-a.
English: Table 8: Interactions with anticoagulants and antiplatelet aggregation medicinal products NSAIDs
Croatian: Tablica 8: Interakcije s antikoagulansima i inhibitorima agregacije trombocita
English: Table 28: Half-life of total dabigatran in healthy subjects and subjects with impaired renal function.
Croatian: Tablica 28: Poluvijek dabigatrana kod zdravih dobrovoljaca i bolesnika s oštećenom funkcijom bubrega.
English: • Prescriber Guide
Croatian: • Upute za propisivača lijeka
English: Table 11: Bleeding events in a study testing the prevention of thromboembolic stroke and systemic embolism in patients with atrial fibrillation
Croatian: Tablica 11: Incidencija krvarenja u studiji prevencije tromboembolijskog moždanog udara i sistemske embolije u bolesnika s fibrilacijom atrija
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR 75 mg
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER ZA 75 mg
English: if you are suffering from an inflammation of the gullet or stomach.
Croatian: Bolovi u trbuhu ili želucu
English: How to store Pradaxa
Croatian: Kako čuvati Pradaxu
English: • Moderate renal impairment (30-50 mL/min
Croatian: • umjereno oštećenje bubrega (CrCL 30-50 mL/min)
English: Table 16: Analysis of first occurrence of ischemic or haemorrhagic strokes during the study period in RE-LY.
Croatian: Tablica 16: Analiza prve pojave ishemijskih ili hemoragijskih moždanih udara u RE-LY
English: Concomitant administration of P-gp inhibitors (see table 6) is expected to result in increased dabigatran plasma concentrations.
Croatian: Smatra se da istodobna primjena P-gp inhibitora (vidjeti tablicu 6) rezultira povećanim koncentracijama dabigatrana u plazmi.
English: Dose reduction recommended Patients with moderate renal impairment (creatinine clearance (CrCL) 30-50 mL/min)
Croatian: Preporučeno sniženje doze Bolesnici s umjerenim oštećenjem bubrega (klirens kreatinina, CrCL 30-50 mL/min)
English: Table 19: Major bleeding events by treatment in the individual RE-MODEL and the RE-NOVATE studies.
Croatian: Tablica 19: Pojave velikih krvarenja u RE-MODEL i RE-NOVATE ispitivanjima prema načinu liječenja.
English: Subjects randomized to 150 mg Pradaxa twice daily had a significantly higher risk for major GI bleeds compared with warfarin (hazard ratio 1.48 [p=0.0005].
Croatian: Bolesnici randomizirani na liječenje Pradaxom 150 mg dvaput dnevno imali su značajno veći rizik od velikih gastrointestinalnih krvarenja u usporedbi s varfarinom (relativni rizik 1,48 [p = 0,0005]).
English: Table 21: Analysis of first occurrence of ischemic or haemorrhagic strokes during the study period in RE-LY.
Croatian: Tablica 21: Analiza prve pojave ishemijskih ili hemoragijskih moždanih udara u RE-LY
English: Recurrent symptomatic VTE and all-cause deaths
Croatian: Sekundarni ishodi djelotvornosti Rekurentni simptomatski VTE i smrti svih uzroka Interval pouzdanosti
English: NAME OF THE MEDICINAL PRODUCT Pradaxa 110 mg hard capsules
Croatian: NAZIV LIJEKA Pradaxa 110 mg tvrde kapsule
English: PHARMACEUTICAL FORM AND CONTENTS 50x1 hard capsules.
Croatian: OBLIK I SADRŽAJ 50 x 1 tvrda kapsula.
English: • the 90th percentile of dabigatran plasma concentrations measured at trough (10-16 hours after the previous dose) was about 146 ng/ml,
Croatian: • 90. percentila koncentracije dabigatrana u plazmi mjerene pri kraju dozirnog intervala (1016 sati nakon prethodne doze) bila je oko 146 ng/ml,
English: Table 12: Major bleeding events by treatment in the individual RE-MODEL and the RE-NOVATE studies
Croatian: Tabela 12: Pojave velikih krvarenja u RE-MODEL i RE-NOVATE ispitivanjima prema načinu liječenja.
English: Patients with moderate renal impairment (CrCL 30-50 mL/min)
Croatian: Bolesnici s umjerenim oštećenjem bubrega (CrCL 30-50 mL/min)
English: Any GI bleeds *HR not estimable as there is no event in either one treatment
Croatian: * Omjer hazarda se ne može ocijeniti zbog odsustva događaja u svim liječenjima
English: Concomitant administration of P-gp inhibitors (see table 5) is expected to result in increased dabigatran plasma concentrations.
Croatian: Smatra se da istodobna primjena P-gp inhibitora (vidjeti tablicu 5) rezultira povećanim koncentracijama dabigatrana u plazmi.
English: In phase I studies the exposure (AUC) of dabigatran after the oral administration of Pradaxa is approximately 2.7-fold higher in volunteers with moderate renal insufficiency (CrCL between 30 and 50 mL/min) than in those without renal insufficiency.
Croatian: U ispitivanjima faze I izloženost (AUC) dabigatranu nakon peroralne primjene Pradaxe je oko 2,7 puta veća u dobrovoljaca s umjerenom renalnom insuficijencijom (CrCL između 30 i 50 mL/min) nego u osoba s očuvanom bubrežnom funkcijom.
English: In phase I studies the exposure (AUC) of dabigatran after the oral administration of Pradaxa is approximately 2.7-fold higher in volunteers with moderate renal insufficiency (CrCL between 30-50 mL/min) than in those without renal insufficiency.
Croatian: U ispitivanjima faze I izloženost (AUC) dabigatranu nakon peroralne primjene Pradaxe je oko 2,7 puta veća u dobrovoljaca s umjerenom renalnom insuficijencijom (CrCL između 30 - 50 mL/min) nego u osoba s očuvanom bubrežnom funkcijom.
English: • an ECT at trough (10-16 hours after the previous dose), elevated approximately 3-fold upper limit of normal refers to the observed 90
Croatian: • ECT pri kraju dozirnog intervala (10 - 16 sati nakon prethodne doze), povišen za oko 3 puta od gornje granice normale odnosi se na primijećenu 90. percentilu ECT produljenja od 103 sekunde,
English: Symptomatic DVT 95 % confidence interval
Croatian: Simptomatski DVT Interval pouzdanosti
English: Renal and urinary disorders Genitourological haemorrhage, including haematuria
Croatian: Poremećaji bubrega i mokraćnog sustava Genitourološko krvarenje, uključujući hematuriju često često
English: For patients randomized to warfarin, the median time in therapeutic range (INR 2.0 to 3.0) was 60.6 %.
Croatian: Za bolesnike randomizirane na varfarin, medijan vremena u terapijskom rasponu (INR 2,0 - 3,0) bio je 64,9 %.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOLDING BOX FOR BLISTER for 150 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA BLISTER za 150 mg
English: Cartons containing 10 x 1, 30 x 1 or 60 x 1 hard capsules in perforated aluminium unit dose blisters.
Croatian: Kutije s 10 x 1, 30 x 1 ili 60 x 1 tvrdom kapsulom u perforiranim aluminijskim blisterima s jediničnim dozama.
English: Table 23: Half-life of total dabigatran in healthy subjects and subjects with impaired renal function.
Croatian: Tablica 23: Poluvijek dabigatrana kod zdravih dobrovoljaca i bolesnika s oštećenom funkcijom bubrega.
English: Table 1: Dose recommendations for SPAF, DVT and PE Dose recommendation
Croatian: Tablica 1: Preporučene doze za prevenciju MU i SE kod AF i preporučene doze za DVT i PE Preporučena doza
English: Major:
Croatian: Značajni:
English: Patient Information
Croatian: Podaci o bolesniku
English: Both dabigatran etexilate dual-therapy groups had lower rates of intracranial hemorrhage than the corresponding warfarin triple-therapy group: 3 events (0.3%) in the 110 mg dabigatran etexilate dual-therapy group as compared with 10 events (1.0%) in the warfarin triple-therapy group (HR 0.30; 95% CI 0.08, 1.07; P=0.06) and 1 event (0.1%) in the 150 mg dabigatran etexilate dual-therapy group as compared with 8 events (1.0%) in the corresponding warfarin triple-therapy group (HR 0.12; 95% CI 0.02, 0.98; P=0.047).
Croatian: Obje skupine koje su primale dvojnu terapiju dabigatraneteksilatom imale su niže stope intrakranijalnog krvarenja od odgovarajuće skupine koja je primala trojnu terapiju varfarinom: 3 događaja (0,3%) u skupini koja je primala dvojnu terapiju dabigatraneteksilatom 110 mg u usporedbi s 10 događaja (1,0%) u skupini koja je primala trojnu terapiju varfarinom (HR 0,30; 95% CI 0,08; 1,07; P=0,06) i 1 događaj (0,1%) u skupini koja je primala dvojnu terapiju dabigatraneteksilatom 150 mg u usporedbi s 8 događaja (1,0%) u odgovarajućoj skupini koja je primala trojnu terapiju varfarinom (HR 0,12; 95% CI 0,02; 0,98; P=0,047).
English: The Boehringer Ingelheim logo is printed on the cap and “R75” on the body of the capsule.
Croatian: Logo tvrtke Boehringer Ingelheim je otisnut na kapici, a oznaka “R75” na tijelu kapsule.
English: The cap is imprinted with the Boehringer Ingelheim company symbol, the body with “R75”.
Croatian: Kapica ima otisnut simbol tvrtke Boehringer Ingelheim, a tijelo oznaku “R75”.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 110 mg of dabigatran etexilate (as mesilate).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tvrda kapsula sadrži 110 mg dabigatraneteksilata (u obliku dabigatraneteksilatmesilata).
English: Steady state geometric mean dabigatran peak plasma concentration, measured around 2 hours after 150 mg dabigatran etexilate administration twice daily, was 175 ng/mL, with a range of 117-275 ng/mL (25
Croatian: Geometrijska srednja vrijednost vršne koncentracije dabigatrana u plazmi u stanju dinamične ravnoteže, mjerena oko 2 sata nakon primjene 150 mg dabigatraneteksilata dvaput dnevno, bila je 175 ng/mL, s interkvartilnim rasponom 117 - 275 ng/mL (percentilni raspon 25.-75.).
English: Table 2: Dose recommendations for SPAF, DVT and PE Dose recommendation
Croatian: Tablica 2: Preporučene doze za prevenciju MU i SE kod AF i preporučene doze za DVT i PE
English: Table 5 shows coagulation test thresholds at trough that may be associated with an increased risk of bleeding (see section 5.1)
Croatian: Tablica 5 pokazuje pragove testa koagulacije pri najnižim vrijednostima koje mogu biti povezane s povećanim rizikom od krvarenja (vidjeti dio 5.1)
English: Uncommon (may affect up to 1 in 100 people): - Bleeding - Bleeding may happen into a joint or from an injury - Bleeding may happen from piles - A fall in the number of red cells in the blood - Haematoma formation - Coughing of blood or blood stained sputum - Allergic reaction - Sudden change of the skin which affects its colour and appearance - Itching - Ulcer in the stomach or bowel - Inflammation of the gullet and stomach - Reflux of gastric juice into the gullet - Feeling sick - Vomiting - Belly ache or stomach ache - Frequent loose or liquid bowel movements - Unusual laboratory test results on liver function - Liver enzymes increased
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba): - Krvarenje -Krvarenje može biti u zglob ili iz ozljede -Krvarenje može biti iz hemoroida -Pad broja crvenih krvnih stanicau krvi -Stvaranje krvnih podljeva (hematoma) -Kašljanje krvi ili krvavog sputuma -Alergijska reakcija -Naglepromjeneboje i izgleda kože -Svrbež -Ulkus želuca ili crijeva -Upala jednjaka i želuca -Refluks želučanog soka u jednjak -Osjećaj mučnine -Povraćanje -Bol u trbuhu ili želucu -Česta mekana ili tekuća stolica -Neuredni nalazi laboratorijskih testovajetrene funkcije -Povišene vrijednosti jetrenih enzima
English: Table 13: Half-life of total dabigatran in healthy subjects and subjects with impaired renal function.
Croatian: Tablica 13: Poluvijek dabigatrana kod zdravih dobrovoljaca i bolesnika s oštećenom funkcijom bubrega.
English: Table 3 shows coagulation test thresholds at trough that may be associated with an increased risk of bleeding (see section 5.1)
Croatian: Tablica 3 pokazuje pragove testa koagulacije pri najnižim vrijednostima koje mogu biti povezane s povećanim rizikom od krvarenja (vidjeti dio 5.1)
English: NAME OF THE MEDICINAL PRODUCT Pradaxa 150 mg hard capsules
Croatian: NAZIV LIJEKA Pradaxa 150 mg tvrde kapsule
English: Table 18: Analysis of total VTE and all cause mortality during the treatment period in the RE-NOVATE and the RE-MODEL orthopaedic surgery studies.
Croatian: Tablica 18: Analiza ukupnih VTE-a i i svih uzroka mortaliteta tijekom razdoblja liječenja u ispitivanjima RE-NOVATE i RE-MODEL kod ortopedskih kirurških zahvata.
English: The Boehringer Ingelheim logo is printed on the cap and “R110” on the body of the capsule.
Croatian: Logo tvrtke Boehringer Ingelheim je otisnut na kapici, a oznaka “R110” na tijelu kapsule.