FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: Obe skupini z dvojno terapijo z dabigatran eteksilatom sta imeli nižje stopnje možganskih krvavitev kot ustrezna skupina s trojno terapijo z varfarinom: 3 dogodki (0,3 %) v skupini z dvojno terapijo z dabigatran eteksilatom 110 mg v primerjavi z 10 dogodki (1,0 %) v skupini s trojno terapijo z varfarinom (RO 0,30; 95-% IZ 0,08; 1,07; P = 0,06) in 1 dogodek (0,1%) v skupini z dvojno terapijo z dabigatran eteksilatom 150 mg v primerjavi z 8 dogodki (1,0 %) v ustrezni skupini s trojno terapijo z varfarinom (RO 0,12; 95-% IZ 0,02; 0,98; P = 0,047).
English: NAME OF THE MEDICINAL PRODUCT Pradaxa 150 mg hard capsules
Slovenian: IME ZDRAVILA Pradaxa 150 mg trde kapsule
English: Dose reduction recommended Patients with moderate renal impairment (creatinine clearance (CrCL) 30-50 mL/min)
Slovenian: Priporočeno zmanjšanje odmerka Bolniki z zmerno ledvično okvaro (kreatininski očistek (CrCl) 30-50 ml/min)
English: Primary VTE prevention after hip or knee replacement surgery
Slovenian: Primarno preprečevanje VTE po operativni vstavitvi umetnega kolka ali kolena
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).
Slovenian: Za odkrivanje znakov krvavitev ali anemije priporočamo pozorno spremljanje ves čas zdravljenja, še zlasti pri kombinaciji dejavnikov tveganja (glejte zgornjo preglednico 4).
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
Slovenian: • EKT pri najnižji vrednosti (10 do 16 ur po prejšnjem odmerku), povečan približno na 3-kratno zgornjo mejo normalne vrednosti, se nanaša na 90. percentil podaljšanja EKT za 103 sekunde;
English: Given the available clinical and kinetic data no adjustment is necessary (see section 5.2), but close clinical surveillance is recommended (see section 4.4).
Slovenian: S priporočenim odmerjanjem je zelo malo kliničnih izkušenj pri bolnikih s telesno maso nižjo od 50 kg ali višjo od 110 kg. Glede na dosegljive klinične in kinetične podatke odmerka ni potrebno prilagajati (glejte poglavje 5.2), priporočeno pa je natančno klinično spremljanje (glejte poglavje 4.4).
English: Patients were randomized to dabigatran etexilate 110 mg bid dualtherapy, dabigatran etexilate 150 mg bid dual-therapy or warfarin triple-therapy.
Slovenian: Bolniki so bili randomizirani za dvojno terapijo z dabigatran eteksilatom 110 mg dvakrat na dan, dvojno terapijo z dabigatran eteksilatom 150 mg dvakrat na dan ali trojno terapijo z varfarinom.
English: Prevention of stroke and systemic embolism in adult patients with NVAF with one or more risk factors
Slovenian: Preprečevanje možganske kapi in sistemskih emboličnih dogodkov pri odraslih bolnikih z NVAF in enim ali več dejavniki tveganja
English: No data aPTT [x-fold upper limit of normal] > 1.3 INR
Slovenian: ni podatkov aPTČ [x-kratna zgornja meja normalne vrednosti] INR
English: Table 8: Interactions with anticoagulants and antiplatelet aggregation medicinal products NSAIDs
Slovenian: Preglednica 8: Medsebojno delovanje z antikoagulanti in zaviralci agregacije trombocitov
English: Table 5 shows coagulation test thresholds at trough that may be associated with an increased risk of bleeding (see section 5.1)
Slovenian: Preglednica 5 kaže najnižje mejne vrednosti koagulacijskih preskusov, ki lahko kažejo na povečano tveganje krvavitve (glejte poglavje 5.1)
English: Patients can stay on Pradaxa while being cardioverted.
Slovenian: Bolniki lahko med kardioverzijo nadaljujejo z jemanjem zdravila Pradaxa.
English: After knee replacement surgery
Slovenian: Po operativni vstavitvi umetnega kolena
English: Dose reduction recommended Patients with moderate renal impairment (creatinine clearance (CrCL 30-50 mL/min)
Slovenian: Priporočeno zmanjšanje odmerka Bolniki z zmerno ledvično okvaro (kreatininski očistek (CrCL 30-50 ml/min)
English: Wound haemorrhage
Slovenian: Ledvična okvara
English: Pradaxa 150 mg twice daily
Slovenian: Zdravilo Pradaxa 150 mg dvakrat na dan
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.
Slovenian: Incidenca sestavljenega opazovanega dogodka smrti, trombemboličnih dogodkov (miokardni infarkt, možganska kap ali sistemska embolija) ali nenačrtovane revaskularizacije je bila v obeh skupinah z dvojno terapijo z dabigatran eteksilatom skupaj enakovredna skupini s trojno terapijo z varfarinom (13,7 % v primerjavi s 13,4 %; RO 1,04; 95-% IZ: 0,84; 1,29; P = 0,0047 za neinferiornost).
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).
Slovenian: Velikih krvavitev po TIMI (tromboliza pri miokardnem infarktu)¸ kot del opisne analize, je bilo v obeh skupinah z dvojno terapijo z dabigatran eteksilatom manj kot v skupini s trojno terapijo z varfarinom: 14 dogodkov (1,4 %) v skupini z dvojno terapijo z dabigatran eteksilatom 110 mg v primerjavi s 37 dogodki (3,8 %) v skupini s trojno terapijo z varfarinom (RO 0,37; 95-% IZ 0,20; 0,68; P = 0,002) in 16 dogodkov (2,1 %) v skupini z dvojno terapijo z dabigatran eteksilatom 150 mg v primerjavi s 30 dogodki (3,9 %) v ustrezni skupini s trojno terapijo z varfarinom (RO 0,51; 95-% IZ 0,28; 0,93; P = 0,03).
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
Slovenian: Geometrična sredina največje koncentracije dabigatrana v plazmi v ravnotežnem stanju, merjena okrog 2 uri po dajanju 150 mg dabigatran eteksilata dvakrat dnevno je bila 175 ng/ml, njen razpon pa je bil 117-275 ng/ml (25. do 75. percentile).
English: Concomitant administration of P-gp inhibitors (see table 6) is expected to result in increased dabigatran plasma concentrations.
Slovenian: Sočasno dajanje zaviralcev P-gp (glejte preglednico 6) predvidoma poveča koncentracijo dabigatrana v plazmi.
English: Prevention of stroke and systemic embolism in adult patients with NVAF with one or more risk factors (SPAF)
Slovenian: Preprečevanje možganske kapi in sistemskih embolij pri bolnikih z NVAF z enim ali več dejavniki tveganja (SPAF)
English: Patients with moderate renal impairment (CrCL between 30 and 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).
Slovenian: Bolniki z zmerno ledvično okvaro (CrCl med 30 in 50 ml/min) so imeli v primerjavi z bolniki brez ledvične okvare (CrCl ≥ 80 ml/min) pred odmerkom in po odmerku povprečno 2,29- oziroma 1,81-krat večje koncentracije dabigatrana v plazmi.
English: Each hard capsule contains 75 mg dabigatran etexilate (as mesilate).
Slovenian: Ena trda kapsula vsebuje 75 mg dabigatran eteksilata (v obliki mesilata).
English: Take Pradaxa as recommended for the following conditions:
Slovenian: Ob jemanju zdravila Pradaxa upoštevajte naslednja navodila:
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].
Slovenian: Pri preizkušancih, naključno uvrščenih v zdravljenje z zdravilom Pradaxa po 150 mg dvakrat na dan, je bilo tveganje večjih krvavitev v prebavilih značilno večje kot v skupini, ki je jemala varfarin (razmerje tveganja 1,48 [p = 0,0005]).
English: Bleeding can occur at any site during therapy with Pradaxa.
Slovenian: Med zdravljenjem z zdravilom Pradaxa se lahko krvavitev pojavi na katerem koli mestu.
English: Pradaxa 150 mg hard capsules are also available in polypropylene (plastic) bottles with 60 hard capsules.
Slovenian: Pradaxa 150 mg trde kapsule so na voljo tudi v polipropilenski plastenki po 60 trdih kapsul.
English: Pradaxa 150 mg twice daily vs. Warfarin
Slovenian: Zdravilo Pradaxa 150 mg dvakrat na dan Varfarin
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).
Slovenian: Za odkrivanje znakov krvavitev ali anemije, priporočamo pozorno spremljanje ves čas zdravljenja, še zlasti pri kombinaciji dejavnikov tveganja (glejte zgornjo preglednico 3).
English: Concomitant administration of P-gp inhibitors (see table 7) is expected to result in increased dabigatran plasma concentrations.
Slovenian: Sočasno dajanje zaviralcev P-gp (glejte preglednico 7) predvidoma poveča koncentracijo dabigatrana v plazmi.
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
Slovenian: 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: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 75 mg of dabigatran etexilate (as mesilate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena trda kapsula vsebuje 75 mg dabigatran eteksilata (v obliki mesilata).
English: DATE OF REVISION OF THE TEXT
Slovenian: Priporočilo o odmerjanju
English: Table 2 summarises factors which may increase the haemorrhagic risk.
Slovenian: V preglednici 2 so povzeti dejavniki, ki lahko povečajo tveganje krvavitve.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOLDING BOX FOR BLISTER for 75 mg
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PRETISNI OMOT po 75 mg
English: Table 3 shows coagulation test thresholds at trough that may be associated with an increased risk of bleeding (see section 5.1)
Slovenian: Preglednica 3 kaže najnižje mejne vrednosti koagulacijskih preskusov, ki lahko kažejo na povečano tveganje krvavitve (glejte poglavje 5.1)
English: Table 4 summarises factors which may increase the haemorrhagic risk.
Slovenian: V preglednici 4 so povzeti dejavniki, ki lahko povečajo tveganje krvavitve.
English: Concomitant administration of P-gp inhibitors (see table 5) is expected to result in increased dabigatran plasma concentrations.
Slovenian: Sočasno dajanje zaviralcev P-gp (glejte preglednico 5) predvidoma poveča koncentracijo dabigatrana v plazmi.
English: 95 % confidence interval VTE-related deaths 95 % confidence interval All-cause deaths
Slovenian: 95-odstotni interval zaupanja Smrti vseh vzrokov
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
Slovenian: 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: In the phase III study RE-LY (SPAF, see section 5.1) the overall rate of MI was 0.82, 0.81, and 0.64 % / year for dabigatran etexilate 110 mg twice daily, dabigatran etexilate 150 mg twice daily and warfarin, respectively, an increase in relative risk for dabigatran of 29 % and 27 % compared to warfarin.
Slovenian: V študiji III. faze RE-LY (SPAF) je skupna pojavnost miokardnih infarktov na leto med zdravljenjem z dabigatran eteksilatom v odmerkih po 110 mg dvakrat na dan dosegla 0,82 %, dabigatran eteksilatom v odmerkih po 150 mg dvakrat na dan 0,81 %, in varfarinom 0,64 %, kar pomeni numerično povečanje relativnega tveganja ob dabigatranu za 29 % in 27 % v primerjavi z varfarinom (glejte poglavje 5.1).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 110 mg of dabigatran etexilate (as mesilate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena trda kapsula vsebuje 110 mg dabigatran eteksilata (v obliki mesilata).
English: Table 7: Interactions with anticoagulants and antiplatelet aggregation medicinal products NSAIDs
Slovenian: Preglednica 7: Medsebojno delovanje z antikoagulanti in zaviralci agregacije trombocitov
English: Hazard ratio vs warfarin (95% confidence interval)
Slovenian: Razmerje ogroženosti v primerjavi z varfarinom (95-odstotni interval zaupanja)
English: Table 6: Interactions with anticoagulants and antiplatelet aggregation medicinal products NSAIDs
Slovenian: Preglednica 6: Medsebojno delovanje z antikoagulanti in zaviralci agregacije trombocitov
English: Pradaxa 110 mg hard capsules dabigatran etexilate
Slovenian: Pradaxa 110 mg trde kapsule dabigatran eteksilat
English: Intracranial bleeding
Slovenian: Hemoragična možganska kap
English: The majority (80.8 %) of the subjects were in the ≥ 50 kg and < 100 kg category with no clear difference detected (see sections 4.2 and 4.4).
Slovenian: Večina (80,0 %) preizkušancev je imela telesno maso med ≥ 50 in < 100 kg.
English: Dose reductions are recommended for patients who receive concomitantly verapamil (see table 2 above and sections 4.4 and 4.5).
Slovenian: Pri bolnikih, ki se sočasno zdravijo z verapamilom, je priporočeno zmanjšanje odmerkov (glejte preglednico 2 zgoraj in poglavji 4.4 in 4.5).
English: 95% confidence interval non-inferiority margin Secondary efficacy endpoints Recurrent symptomatic VTE and allcause deaths
Slovenian: 95-odstotni interval zaupanja meja enakovrednosti Sekundarni učinkovitostni opazovani dogodki
English: Composite of total VTE (including PE, proximal and distal DVT, whatever symptomatic or asymptomatic detected by routine venography) and all-cause mortality constituted the primary end-point for both studies.
Slovenian: V obeh študijah je bil primarni opazovani dogodek sestavljeni opazovani dogodek, in sicer vsi venski trombembolični dogodki (tudi pljučna embolija, proksimalna in distalna globoka venska tromboza, simptomatska ali nesimptomatska, odkrita med rutinsko venografijo) in umrljivost iz vseh vzrokov.
English: • Congenital or acquired coagulation disorders
Slovenian: • prirojene ali pridobljene motnje strjevanja krvi
English: prevent the formation of blood clots in the veins after knee or hip replacement surgery.
Slovenian: - preprečevanje nastajanja krvnih strdkov v venah po vstavitvi umetnega kolka ali kolena,
English: NAME OF THE MEDICINAL PRODUCT Pradaxa 75 mg hard capsules dabigatran etexilate
Slovenian: IME ZDRAVILA Pradaxa 75 mg trde kapsule dabigatran eteksilat
English: Table 3: Factors which may increase the haemorrhagic risk.
Slovenian: Preglednica 3: Dejavniki, ki lahko povečajo tveganje za krvavitev
English: Rare Injury, poisoning and procedural complications Traumatic haemorrhage
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih krvavitev pri poškodbi redki občasni krvavitev na mestu incizije redki redki
English: Diseases / procedures with special haemorrhagic risks
Slovenian: Bolezni / postopki, ki povečujejo tveganje za krvavitve
English: Blister and bottle
Slovenian: Pretisni omot in plastenka
English: Pradaxa 150 mg hard capsules dabigatran etexilate
Slovenian: Pradaxa 150 mg trde kapsule dabigatran eteksilat
English: •An instruction how to take Pradaxa
Slovenian: •Navodila za jemanje zdravila Pradaxa
English: A coagulation test (see section 4.4) may help to identify patients with an increased bleeding risk caused by excessive dabigatran exposure.
Slovenian: Pri odkrivanju bolnikov s povečanim tveganjem krvavitve zaradi povečane izpostavljenosti dabigatranu je lahko v pomoč koagulacijski test (glejte poglavje 4.4).
English: PHARMACEUTICAL FORM AND CONTENTS 60x1 hard capsules.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 60 x 1 trda kapsula.
English: Each hard capsule contains 110 mg dabigatran etexilate (as mesilate).
Slovenian: Ena trda kapsula vsebuje 110 mg dabigatran eteksilata (v obliki mesilata).
English: Dose reductions are recommended for patients who receive concomitantly verapamil (see table 1 above and sections 4.4 and 4.5).
Slovenian: Pri bolnikih, ki se sočasno zdravijo z verapamilom, so priporočena zmanjšanja odmerkov (glejte preglednico 1 zgoraj in poglavji 4.4 in 4.5).
English: No dose adjustment is necessary in patients with mild renal impairment (CrCL 50- ≤ 80 mL/min).
Slovenian: Bolnikom z blago ledvično okvaro (CrCl 50 do ≤ 80 ml/min) odmerka ni potrebno prilagoditi.
English: Patients with moderate renal impairment (CrCL 30-50 mL/min)
Slovenian: Bolniki z zmerno ledvično okvaro (kreatininski očistek (CrCL) 30-50 ml/min)
English: Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults (DVT/PE treatment)
Slovenian: Zdravljenje globoke venske tromboze (GVT) in pljučne embolije (PE) pri odraslih (zdravljenje GVT/PE)
English: Table 5: Coagulation test thresholds at trough that may be associated with an increased risk of bleeding.
Slovenian: Preglednica 5: Najnižje mejne vrednosti koagulacijskih testov, ki lahko kažejo na zvečano tveganje za krvavitev
English: RE-MODEL (knee) Treated patients N Number of MBE N(%)
Slovenian: RE-MODEL (koleno) zdravljeni bolniki N Število večjih dogodkov s krvavitvijo N (%)
English: Table 4 shows coagulation test thresholds at trough that may be associated with an increased risk of bleeding (see section 5.1).
Slovenian: Preglednica 4 kaže najnižje mejne vrednosti koagulacijskih preskusov, ki lahko kažejo na povečano tveganje krvavitve (glejte poglavje 5.1)
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.
Slovenian: V študiji I. faze je izpostavljenost (AUC) dabigatrana po peroralni aplikaciji zdravila Pradaxa pri prostovoljcih z zmerno ledvično insuficienco (CrCl 30 do 50 ml/min) približno 2,7 krat večja kot pri osebah brez ledvične insuficience.
English: Table 5: Discontinuation rules before invasive or surgical procedures
Slovenian: Preglednica 5: Postopek ukinjanja zdravila pred invazivnimi ali kirurškimi posegi
English: the increase of dabigatran exposure is 1.56-fold and 1.46fold for Cmax and AUC, respectively.
Slovenian: Po večkratnih odmerkih tikagrelorja po 90 mg, dvakrat na dan, se izpostavljenost dabigatranu poveča za 1,56-krat, Cmax in AUC pa za 1,46-krat.
English: Angioedema
Slovenian: Takrolimus
English: Table 3 summarises factors which may increase the haemorrhagic risk.
Slovenian: V preglednici 3 so povzeti dejavniki, ki lahko povečajo tveganje krvavitve.
English: Prevention of recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults (DVT/PE prevention)
Slovenian: Preprečevanje ponovitve globoke venske tromboze (GVT) in pljučne embolije (PE) pri odraslih (preprečevanje GVT/PE)
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.
Slovenian: Če uporabljate zdravila, ki vsebujejo verapamil, se morate zaradi možnega povečanega tveganja krvavitve zdraviti z manjšim odmerkom zdravila Pradaxa in sicer s skupno 220 mg, to je po eno kapsulo po 110 mg dvakrat na dan.
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
Slovenian: Preglednica 16: Dogodki krvavitev v študiji RE-SONATE, v kateri so proučevali preprečevanje globoke venske tromboze (GVT) in pljučne embolije (PE) Zdravilo Pradaxa 150 mg dvakrat na dan
English: Patients aged 75 or above *For patients with moderate renal impairment concomitantly treated with verapamil see Special populations
Slovenian: *Pri bolnikih z zmerno ledvično okvaro, ki se sočasno zdravijo z verapamilom glejte poglavje Posebne skupine bolnikov.
English: The recommended doses of Pradaxa in the indications SPAF, DVT and PE are shown in table 1.
Slovenian: Priporočeni odmerki zdravila Pradaxa pri indikacijah za SPAF, GVT in PE so prikazani v preglednici 1.
English: th percentile of dabigatran plasma concentrations measured at trough (10-16 hours after the previous dose) was about 200 ng/mL,
Slovenian: • je bil 90. percentil koncentracije dabigatrana v plazmi, izmerjen pri najmanjši vrednosti (10 do 16 ur po prejšnjem odmerku), približno 200 ng/ml;
English: Each hard capsule contains 150 mg dabigatran etexilate (as mesilate).
Slovenian: Ena trda kapsula vsebuje 150 mg dabigatran eteksilata (v obliki mesilata).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 150 mg of dabigatran etexilate (as mesilate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena trda kapsula vsebuje 150 mg dabigatran eteksilata (v obliki mesilata).
English: Table 5 summarises discontinuation rules before invasive or surgical procedures.
Slovenian: V preglednici 5 so zbrana navodila o ukinitvi zdravila pred invazivnimi ali kirurškimi posegi.
English: Table 7: Other interactions
Slovenian: Druga medsebojna delovanja Preglednica 7: Druga medsebojna delovanja
English: When rapid reversal of the anticoagulation effect is required the specific reversal agent (Praxbind, idarucizumab) to Pradaxa is available.
Slovenian: Za hitro izničenje antikoagulacijskega učinka dabigatrana je na voljo specifična protiučinkovina (zdravilo Praxbind, idarucizumab).
English: Musculoskeletal and connective tissue disorders Haemarthrosis
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva hemartroza občasni
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)
Slovenian: Preglednica 12: Dogodki krvavitev v študijah RE-COVER in RE-COVER II, v katerih so proučevali zdravljenje globoke venske tromboze (GVT) in pljučne embolije (PE)
English: Treated
Slovenian: ZDRAVILA
English: Urticaria
Slovenian: Tikagrelor
English: Blood and lymphatic system disorders Haemoglobin decreased
Slovenian: Bolezni krvi in limfatičnega sistema znižanje hemoglobina pogosti anemija občasni znižanje hematokrita občasni trombocitopenija redki
English: The recommended doses of Pradaxa in the indications SPAF, DVT and PE are shown in table 2.
Slovenian: Priporočeni odmerki zdravila Pradaxa pri indikacijah za SPAF, GVT in PE so prikazani v preglednici 2.
English: th percentile of dabigatran trough levels or a coagulation assay such as aPTT measured at trough (for aPTT thresholds see section 4.4, table 5) is considered to be associated with an increased risk of bleeding.
Slovenian: Pri tem sicer velja, da je preseganje 90. percentila najnižjih ravni dabigatrana ali vrednosti preskusa koagulacije, kot je aPTČ, takrat ko so najnižje (za mejne vrednosti aPTČ glejte poglavje 4.4, preglednica 5), povezano s povečanim tveganjem krvavitve.
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.
Slovenian: Preglednica 17.: Analiza hujše VTE in z VTE povezane umrljivosti med zdravljenjem v študijah na področju ortopedske kirurgije RE-MODEL in RE-NOVATE
English: Discontinuation of Pradaxa
Slovenian: Prenehanje jemanja zdravila Pradaxa