FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 16: Bleeding events in study RE-SONATE testing prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) Pradaxa 150 mg twice daily
Croatian: Tablica 13: Događaji krvarenja u ispitivanju RE-MEDY koje ispituje prevenciju duboke venske tromboze (DVT) i plućne embolije (PE) Pradaxa 150 mg dvaput dnevno
English: -if an operation involves a catheter or injection into your spinal column (e.g. for epidural or spinal anaesthesia or pain reduction): it is very important to take Pradaxa before and after the operation exactly at the times you have been told by your doctor.
Croatian: ako operacija uključuje uvođenje katetera ili injekciju u kralježnicu (npr. zbog epiduralne ili spinalne anestezije ili smanjenja bolova): veoma je važno uzeti Pradaxu prije i nakon operacije točno u vrijeme kada Vam je liječnik rekao da je uzmete. odmah obavijestite svog liječnika ako osjetite utrnulost ili slabost u nogama ili tegobe s crijevima ili mokraćnim mjehurom nakon prestanka anestezije, jer to zahtijeva hitno liječenje.
English: Table 6: Interactions with anticoagulants and antiplatelet aggregation medicinal products NSAIDs
Croatian: Tablica 6: Interakcije s antikoagulansima i inhibitorima agregacije trombocita
English: Package leaflet: Information for the patient Pradaxa 75 mg hard capsules dabigatran etexilate
Croatian: Uputa o lijeku: Informacije za bolesnika Pradaxa 75 mg tvrde kapsule dabigatraneteksilat
English: th th percentile range).The dabigatran geometric mean trough concentration, measured at the end of the dosing interval (i.e. 24 hours after a 220 mg dabigatran dose), was on average 22.0 ng/mL, with a range of 13.0-35.7 ng/mL (25
Croatian: Geometrijska srednja najniža vrijednost koncentracije dabigatrana, mjerena na kraju dozirnog intervala (tj. 24 sata nakon doze dabigatrana od 220 mg), bila je u prosjeku 22,0 ng/mL, s rasponom od 13,0-35,7 ng/mL (percentilni raspon 25.-75.).
English: Table 5: Coagulation test thresholds at trough that may be associated with an increased risk of bleeding.
Croatian: Tablica 5: Pragovi testa koagulacije pri najnižim vrijednostima koje mogu biti povezane s povećanim rizikom od krvarenja.
English: Table 4 shows coagulation test thresholds at trough that may be associated with an increased risk of bleeding (see section 5.1).
Croatian: Tablica 4 pokazuje pragove testa koagulacije pri najnižim vrijednostima koje mogu biti povezane s povećanim rizikom od krvarenja (vidjeti dio 5.1)
English: Pradaxa 150 mg twice daily vs. warfarin
Croatian: 150 mg dvaput dnevno naspram varfarina
English: Pradaxa 110 mg twice daily vs. Warfarin
Croatian: 110 mg dvaput dnevno naspram varfarina
English: The cap is imprinted with the Boehringer Ingelheim company symbol, the body with “R110”.
Croatian: Kapica ima otisnut simbol tvrtke Boehringer Ingelheim, a tijelo oznaku “R110”.
English: The concomitant use of antiplatelets ASA or clopidogrel approximately doubles MBE rates with both dabigatran etexilate and warfarin.
Croatian: Istovremena primjena antitrombotika, ASA, ili klopidogrela približno udvostručuje stopu događaja velikih krvarenja i uz dabigatraneteksilat i varfarin.
English: Elective surgery
Croatian: Elektivni kirurški zahvati
English: th percentile of dabigatran plasma concentrations measured at trough (10-16 hours after the previous dose) was about 200 ng/mL,
Croatian: • 90. percentila koncentracija dabigatrana u plazmi, mjereno pri kraju dozirnog intervala (10-16 sati nakon prethodne doze), bila je oko 200 ng/mL,
English: the increase of dabigatran exposure is 1.56-fold and 1.46fold for Cmax and AUC, respectively.
Croatian: Nakon višekratnih doza tikagrelora od 90 mg dvaput dnevno izloženost dabigatranu se povećala 1,56 puta za Cmax i 1,46 puta za AUC.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 150 mg of dabigatran etexilate (as mesilate).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tvrda kapsula sadrži 150 mg dabigatraneteksilata (u obliku dabigatraneteksilatmesilata).
English: As part of the descriptive analysis, TIMI (Thrombolysis In Myocardial Infarction) major bleeding events was lower in both dabigatran etexilate dual-therapy groups than in the warfarin triple-therapy group: 14 events (1.4%) in the dabigatran etexilate 110 mg dual-therapy group as compared with 37 events (3.8%) in the warfarin triple-therapy group (HR 0.37; 95% CI 0.20, 0.68; P=0.002) and 16 events (2.1%) in the dabigatran etexilate 150 mg dual-therapy group as compared with 30 events (3.9%) in the corresponding warfarin triple-therapy group (HR 0.51; 95% CI 0.28, 0.93; P=0.03).
Croatian: U deskriptivnoj analizi, događaji velikog krvarenja prema TIMI-ju (tromboliza u infarktu miokarda) bili su rjeđi u obje skupine koje su primale dvojnu terapiju dabigatraneteksilatom u odnosu na skupinu koja je primala trojnu terapiju varfarinom: 14 događaja (1,4%) u skupini koja je primala dvojnu terapiju dabigatraneteksilatom 110 mg u usporedbi s 37 događaja (3,8%) u skupini koja je primala trojnu terapiju varfarinom (HR 0,37; 95% CI 0,20, 0,68; P=0,002) i 16 događaja (2,1%) u skupini koja je primala dvojnu terapiju dabigatraneteksilatom 150 mg u usporedbi s 30 događaja (3,9%) u odgovarajućoj skupini koja je primala trojnu terapiju varfarinom HR 0,51; 95% CI 0,28; 0,93; P=0,03).
English: The Boehringer Ingelheim logo is printed on the cap and “R150” on the body of the capsule.
Croatian: Logo tvrtke Boehringer Ingelheim je otisnut na kapici, a oznaka “R150” na tijelu kapsule.
English: Table 4: Coagulation test thresholds at trough that may be associated with an increased risk of bleeding.
Croatian: Tablica 4: Pragovi testa koagulacije pri najnižim vrijednostima koje mogu biti povezane s povećanim rizikom od krvarenja.
English: Table 2: Factors which may increase the haemorrhagic risk.
Croatian: Tablica 2: Čimbenici koji mogu povećati rizik od krvarenja.
English: Table 3: Coagulation test thresholds at trough that may be associated with an increased risk of bleeding.
Croatian: Tablica 3: Pragovi testa koagulacije pri najnižim vrijednostima koje mogu biti povezane s povećanim rizikom od krvarenja.
English: The cap is imprinted with the Boehringer Ingelheim company symbol, the body with “R150”.
Croatian: Kapica ima otisnut simbol tvrtke Boehringer Ingelheim, a tijelo oznaku “R150”.
English: Each hard capsule contains 75 mg dabigatran etexilate (as mesilate).
Croatian: Jedna tvrda kapsula sadrži 75 mg dabigatraneteksilata (u obliku dabigatraneteksilatmesilata).
English: Angioedema
Croatian: Takrolimus
English: Haemoglobin decreased
Croatian: Sniženi haemoglobin manje često nije poznato
English: Prevention of stroke and systemic embolism in adult patients with NVAF with one or more risk factors (SPAF)
Croatian: Prevencija moždanog udara i sistemske embolije kod odraslih bolesnika s NVAF-om s jednim ili više rizičnih faktora (prevencija MU i SE kod AF)
English: During the additional 2.5 years of treatment in RELY-ABLE, with a maximum exposure of over 6 years (total exposure in RELY + RELY-ABLE), the long-term safety profile of dabigatran etexilate was confirmed for both test doses 110 mg b.i.d.
Croatian: Tijekom dodatne 2,5 godine liječenja u ispitivanju RELY-ABLE, uz maksimalnu izloženost dulju od 6 godina (ukupna izloženost u RELY
English: Table 11: Analysis of total VTE and all cause mortality during the treatment period in the RE-NOVATE and the RE-MODEL orthopaedic surgery studies
Croatian: Tabela 11: Analiza ukupnih VTE-a i i svih uzroka mortaliteta tijekom razdoblja liječenja u ispitivanjima RE-NOVATE i RE-MODEL kod ortopedskih kirurških zahvata.
English: After knee replacement surgery
Croatian: Nakon kirurškog zahvata ugradnje endoproteze koljena
English: Each hard capsule contains 150 mg dabigatran etexilate (as mesilate).
Croatian: Jedna tvrda kapsula sadrži 150 mg dabigatraneteksilata (u obliku dabigatraneteksilatmesilata).
English: Package leaflet: Information for the patient Pradaxa 110 mg hard capsules dabigatran etexilate
Croatian: Uputa o lijeku: Informacije za bolesnika Pradaxa 110 mg tvrde kapsule dabigatraneteksilat
English: The dabigatran geometric mean trough concentration, measured at trough in the morning, at the end of the dosing interval (i.e. 12 hours after the 150 mg dabigatran evening dose), was on average 91.0 ng/mL, with a range of 61.0-143 ng/mL (25
Croatian: Geometrijska srednja minimalna koncentracija dabigatrana, mjerena pri minimalnim vrijednostima ujutro, na kraju dozirnog intervala (tj. 12 sati nakon večernje doze 150 mg dabigatrana), bila je, u prosjeku, 91,0 ng/mL, s interkvatilnim rasponom 61,0 - 143 ng/mL (percentilni raspon 25.-75.).
English: Table 17: Analysis of major VTE and VTE-related mortality during the treatment period in the RE-MODEL and the RE-NOVATE orthopaedic surgery studies.
Croatian: Tablica 17: Analiza teških VTE-a i mortaliteta povezanog s VTE-om tijekom razdoblja liječenja u ispitivanjima RE-MODEL i RE-NOVATE kod ortopedskih kirurških zahvata.
English: Table 5: Discontinuation rules before invasive or surgical procedures
Croatian: Tablica 5: Pravila prekida liječenja dabigatranom prije invazivnih ili kirurških postupaka
English: EU/1/08/442/009 10 x 1 capsules EU/1/08/442/01030 x 1 capsules EU/1/08/442/011 60 x 1 capsules EU/1/08/442/019 60 x 1 capsules
Croatian: EU/1/08/442/009 10 x 1 kapsula EU/1/08/442/010 30 x 1 kapsula EU/1/08/442/011 60 x 1 kapsula EU/1/08/442/019 60 x 1 kapsula
English: - The active substance is dabigatran.
Croatian: Djelatna tvar je dabigatraneteksilat.
English: Table 4: Factors which may increase the haemorrhagic risk.
Croatian: Tablica 4: Čimbenici koji mogu povećati rizik od krvarenja.
English: In patients treated for prevention of recurrent of DVT and PE with 150 mg dabigatran etexilate twice daily no pharmacokinetic data are available.
Croatian: Nisu dostupni farmakokinetički podaci za bolesnike koji se liječe radi prevencije rekurentnog DVT-a i PE-a s 150 mg dabigatraneteksilata dvaput dnevno.
English: dTT [ng/mL] ECT [x-fold upper limit of normal]
Croatian: ECT [x puta od gornje granice normale]
English: Tacrolimus
Croatian: Klaritromicin
English: Hypromellose Dimeticone 350
Croatian: Sadržaj kapsule tartaratna kiselina arapska guma hipromeloza dimetikon 350 talk hidroksipropilceluloza
English: Hazard ratio vs warfarin (95% Confidence Interval)
Croatian: Omjer hazarda naspram varfarina (interval pouzdanosti 95%)
English: Table 27: Analysis of the primary and secondary efficacy endpoints (VTE is a composite of DVT and/or PE) until the end of post-treatment period for the RE-SONATE study.
Croatian: Tablica 27: Analiza primarnih i sekundarnih ishoda djelotvornosti (VTE je zbroj DVT-a i/ili PE-a) do kraja razdoblja nakon liječenja za ispitivanje RE-SONATE.
English: EU/1/08/442/005 10 x 1 capsules EU/1/08/442/006 30 x 1 capsules EU/1/08/442/007 60 x 1 capsules EU/1/08/442/018 60 x 1 capsules
Croatian: EU/1/08/442/005 10 x 1 kapsula EU/1/08/442/006 30 x 1 kapsula EU/1/08/442/007 60 x 1 kapsula EU/1/08/442/018 60 x 1 kapsula
English: Table 3: Factors which may increase the haemorrhagic risk.
Croatian: Tablica 3: Čimbenici koji mogu povećati rizik od krvarenja.
English: ulcer in the gullet) - Inflammation of the gullet and stomach
Croatian: Ulkus na želucu ili crijevima (uključujući ulkus na jednjaku) Upala jednjaka i želuca
English: Major bleeding event/clinical relevant bleeds
Croatian: Događaj velikog krvarenja / klinički značajnog krvarenja
English: PHARMACEUTICAL FORM AND CONTENTS 60x1 hard capsules.
Croatian: OBLIK I SADRŽAJ 60 x 1 tvrda kapsula.
English: Table 22: Analysis of the primary and secondary efficacy endpoints (VTE is a composite of DVT and/or PE) until the end of post-treatment period for the RE-SONATE study.
Croatian: Tablica 22: Analiza primarnih i sekundarnih ishoda djelotvornosti (VTE je zbroj DVT-a i/ili PE-a) do kraja razdoblja nakon liječenja za ispitivanje RE-SONATE.
English: Dose of Pradaxa
Croatian: Doza Pradaxe®
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 75 mg dabigatran etexilate (as mesilate).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tvrda kapsula sadrži 75 mg dabigatraneteksilata (u obliku dabigatraneteksilatmesilata).
English: If you are taking verapamil containing medicines, you should be treated with a reduced Pradaxa dose of 220 mg taken as one 110 mg capsule twice a day, because your bleeding risk may be increased.
Croatian: Pradaxe od 220 mg uzete u obliku jedne kapsule od 110 mg dvaput dnevno zbog mogućnosti povećanja rizika od krvarenja.
English: The recommended doses of Pradaxa in the indications SPAF, DVT and PE are shown in table 1.
Croatian: Preporučene doze Pradaxe u indikacijama prevencije MU i SE kod AF i indikacijama DVT-a i PE-a prikazane su u tablici 1.
English: - if you have received an artificial heart valve which requires permanent blood thinning.
Croatian: Vam je trajno potrebno razrjeđivanje krvi.
English: Therefore, the possibility of haemorrhage is to be considered in evaluating the condition in any anticoagulated patient.
Croatian: Stoga je prilikom procjene stanja svakog bolesnika liječenog antikoagulantnom terapijom potrebno uzeti u obzir mogućnost krvarenja.
English: Package leaflet: Information for the patient Pradaxa 150 mg hard capsules dabigatran etexilate
Croatian: Uputa o lijeku: Informacije za bolesnika Pradaxa 150 mg tvrde kapsule dabigatraneteksilat
English: They are ranked under headings of System Organ Class (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).
Croatian: 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).
English: EU/1/08/442/001 10 x 1 capsules EU/1/08/442/002 30 x 1 capsules EU/1/08/442/003 60 x 1 capsules EU/1/08/442/017 60 x 1 capsules
Croatian: EU/1/08/442/001 10 x 1 kapsula EU/1/08/442/002 30 x 1 kapsula EU/1/08/442/003 60 x 1 kapsula EU/1/08/442/017 60 x 1 kapsula
English: FOLDING BOX AND LABEL FOR BOTTLE for 75 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM I UNUTARNJEM PAKIRANJU KUTIJA I NALJEPNICA BOCE za 75 mg
English: Dabigatran, the active moiety of dabigatran etexilate mesilate, is persistent in the environment.
Croatian: Dabigatran, aktivni dio dabigatraneteksilatmesilata, se zadržava u okolišu.
English: Primary Prevention of Venous Thromboembolism in Orthopaedic Surgery Steady state (after day 3) geometric mean dabigatran peak plasma concentration, measured around 2 hours after 220 mg dabigatran etexilate administration, was 70.8 ng/mL, with a range of 35.2-162 ng/mL (25th-75th percentile range).The dabigatran geometric mean trough concentration, measured at the end of the dosing interval (i.e. 24 hours after a 220 mg dabigatran dose), was on average 22.0 ng/mL, with a range of 13.0-35.7 ng/mL (25th-75th percentile range).
Croatian: Primarna prevencija venske tromboembolije u ortopedskoj kirurgiji Geometrijska srednja vrijednost vršne koncentracije dabigatrana u plazmi u stanju dinamične ravnoteže (nakon 3. dana primjene), mjerena oko 2 sata nakon primjene 220 mg dabigatraneteksilata, bila je 70,8 ng/mL, s rasponom od 35,2 - 162 ng/mL (percentilni raspon 25.-75.).
English: Indication SPAF and DVT/PE
Croatian: Indikacija Prevencija MU i SE kod AF i DVT/PE
English: if you know you have impaired kidney function, or you are suffering from dehydration (symptoms include feeling thirsty and passing reduced amounts of dark-coloured (concentrated) urine).
Croatian: ako uzimate protuupalne lijekove, kao što su diklofenak, ibuprofen, piroksikam. ako patite od infekcije srca (bakterijski endokarditis). ako imate umjereno oštećenu bubrežnu funkciju, ili patite od dehidracije (simptomi uključuju osjećaj žeđi te prolaz smanjene količine tamno obojanog (koncentriranog) urina).
English: Table 12: Bleeding events in the studies RE-COVER and RE-COVER II testing the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE)
Croatian: Tablica 12: Događaji krvarenja u ispitivanjima RE-COVER i RE-COVER II, koja ispituju liječenje duboke venske tromboze (DVT) i plućne embolije (PE)
English: Haemorrhagic stroke Incidences (%) Hazard ratio vs. warfarin (95 % CI) p-value % refers to yearly event rate
Croatian: HR naspram varfarina (95 % CI) p-vrijednost % odnosi se na godišnju stopu događaja
English: In order to use Pradaxa
Croatian: U cilju sigurne primjene Pradaxe
English: - if you have a severely reduced liver function or liver disease which could possibly cause death.
Croatian: • Oštećenje ili oboljenje jetre koje bi moglo imati utjecaj na preživljenje
English: Table 21: Analysis of the primary and secondary efficacy endpoints (VTE is a composite of DVT and/or PE) until the end of post-treatment period for the RE-MEDY study
Croatian: Tablica 21: Analiza primarnih i sekundarnih ishoda djelotvornosti (VTE je zbroj DVT-a i/ili PE-a) do kraja razdoblja nakon liječenja za ispitivanje RE-MEDY
English: Table 25: Analysis of the primary and secondary efficacy endpoints (VTE is a composite of DVT and/or PE) until the end of post-treatment period for the pooled studies RECOVER and RE-COVER II
Croatian: Tablica 25: Analiza primarnih i sekundarnih ishoda djelotvornosti (VTE je zbroj DVT-a i/ili PE-a) do kraja razdoblja nakon liječenja za združena ispitivanja RE-COVER i RE-COVER II
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 150 mg dabigatran etexilate (as mesilate).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tvrda kapsula sadrži 150 mg dabigatraneteksilata (u obliku dabigatraneteksilatmesilata).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACK OF 100 (2 PACKS OF 50 HARD CAPSULES) WRAPPED IN TRANSPARENT FOIL - INCLUDING THE BLUE BOX - 110 mg HARD CAPSULES
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA VANJSKOM OMOTU VIŠESTRUKOG PAKIRANJA SA 100 KAPSULA (2 PAKIRANJA S 50 TVRDIH KAPSULA) - ZAMOTANOG U PROZIRNU FOLIJUUKLJUČUJUĆI PLAVI OKVIR - 110 mg TVRDE KAPSULE
English: Table 3: Duration of use for SPAF and DVT/PE Indication Duration of use
Croatian: Tablica 3: Trajanje primjene kod prevencije MU i SE kod AF i kod DVT/PE-a
English: Each hard capsule contains 110 mg dabigatran etexilate (as mesilate).
Croatian: Jedna tvrda kapsula sadrži 110 mg dabigatraneteksilata (u obliku dabigatraneteksilatmesilata).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK OF 180 (3 PACKS OF 60 HARD-CAPSULES) - WITHOUT BLUE BOX110 mg HARD CAPSULES
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VIŠESTRUKO PAKIRANJE OD 180 (3 PAKIRANJA SA 60 TVRDIH KAPSULA) - BEZ PLAVOG OKVIRA - 110 mg TVRDE KAPSULE
English: Table 10: Analysis of major VTE and VTE-related mortality during the treatment period in the RE-MODEL and the RE-NOVATE orthopaedic surgery studies
Croatian: Tablica 10: Analiza teških VTE-a i mortaliteta povezanog s VTE-om tijekom razdoblja liječenja u ispitivanjima RE-MODEL i RE-NOVATE kod ortopedskih kirurških zahvata.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR 150 mg
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER ZA 150 mg
English: Table 6: Discontinuation rules before invasive or surgical procedures
Croatian: Tablica 6: Pravila prekida liječenja dabigatranom prije invazivnih ili kirurških postupaka
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR 110 mg
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER ZA 110 mg
English: (maintenance dose) with 110 mg dabigatran etexilate increased the adjusted dabigatran AUCτ,ss and Cmax,ss 1.26-fold and 1.29-fold, respectively, compared with dabigatran etexilate given alone.
Croatian: Istodobna primjena 90 mg tikagrelora dvaput dnevno (doza održavanja) s 110 mg dabigatraneteksilata povećala je prilagođeni AUCτ,ss dabigatrana za 1,26 puta te njegov Cmax,ss za 1,29 puta, u usporedbi s monoterapijom dabigatraneteksilata.
English: MINIMUM PARTICULARS TO APPEAR ON WHITE BLISTERS OR STRIPS BLISTER FOR 150 mg
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BIJELI BLISTER ILI STRIP BLISTER ZA 150 mg
English: MINIMUM PARTICULARS TO APPEAR ON WHITE BLISTERS OR STRIPS BLISTER FOR 110 mg
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BIJELI BLISTER ILI STRIP BLISTER ZA 110 mg
English: Uncommon (may affect up to 1 in 100 people): - Bleeding may happen from the nose, into the stomach or bowel, from penis/vagina or urinary tract (incl.
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba): - Krvarenje se može razviti iz nosa, u želudac ili crijeva, iz penisa/vagine ili mokraćnog sustava
English: Table 4: Discontinuation rules before invasive or surgical procedures
Croatian: Tablica 4: Pravila prekida liječenja dabigatranom prije invazivnih ili kirurških postupaka
English: • the 90th percentile of aPTT at trough (10-16 hours after the previous dose) was 62 seconds,
Croatian: • 90. percentila aPTT pri kraju dozirnog intervala (10 - 16 sati nakon prethodne doze) bila je
English: Table 5 summarises discontinuation rules before invasive or surgical procedures.
Croatian: Tablica 5 sažima pravila prekida liječenja dabigatranom prije invazivnih ili kirurških postupaka.
English: The recommended doses of Pradaxa in the indications SPAF, DVT and PE are shown in table 2.
Croatian: Preporučene doze Pradaxe u indikacijama prevencije MU i SE kod AF i indikacijama DVT-a i PE-a prikazane su u tablici 2.
English: Prevention of recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults (DVT/PE prevention)
Croatian: Prevencija rekurentne duboke venske tromboze (DVT)i plućne embolije (PE) kod odraslih (prevencija DVT/PE-a)
English: Post procedural haematoma
Croatian: Postproceduralni hematom manje često
English: Table 2: Duration of use for SPAF and DVT/PE Indication Duration of use
Croatian: Tablica 2: Trajanje primjene kod prevencije MU i SE kod AF i kod DVT/PE-a
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK OF 180 (3 PACKS OF 60 HARD-CAPSULES) - WITHOUT BLUE BOX150 mg HARD CAPSULES
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VIŠESTRUKO PAKIRANJE SA 180 (3 PAKIRANJA SA 60 TVRDIH KAPSULA) - BEZ PLAVOG OKVIRA - 150 mg TVRDE KAPSULE
English: The duration of use of Pradaxa in the indications SPAF, DVT and PE are shown in table 3.
Croatian: Trajanje primjene Pradaxe u indikacijama prevencije MU i SE kod AF i indikaciji DVT-a i PE-a prikazano je u tablici 3.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D UVIJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: FOLDING BOX AND LABEL FOR BOTTLE for 150 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM I UNUTARNJEM PAKIRANJU KUTIJA I NALJEPNICA BOCE za 150 mg
English: Stroke and systemic embolism prevention in patients with atrial fibrillation
Croatian: Prevencija moždanog udara i sistemske embolije kod bolesnika s AF-om
English: Table 20: Analysis of the primary and secondary efficacy endpoints (VTE is a composite of DVT and/or PE) until the end of post-treatment period for the pooled studies RECOVER and RE-COVER II
Croatian: Tablica 20: Analiza primarnih i sekundarnih mjera ishoda djelotvornosti (VTE je zbroj DVTa i/ili PE-a) do kraja razdoblja nakon liječenja za združena ispitivanja RECOVER i RE-COVER II
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 110 mg dabigatran etexilate (as mesilate).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tvrda kapsula sadrži 110 mg dabigatraneteksilata (u obliku dabigatraneteksilatmesilata).
English: Steady state (after day 3) geometric mean dabigatran peak plasma concentration, measured around 2 hours after 220 mg dabigatran etexilate administration, was 70.8 ng/mL, with a range of 35.2-162 ng/mL (25
Croatian: Geometrijska srednja vrijednost vršne koncentracije dabigatrana u plazmi u stanju dinamične ravnoteže (nakon 3. dana primjene), mjerena oko 2 sata nakon primjene 220 mg dabigatraneteksilata, bila je 70,8 ng/mL, s rasponom od 35,2 - 162 ng/mL (percentilni raspon 25.-75.).