FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Slovenian: Če jemljete zdravilo, ki vsebuje amiodaron, kinidin ali verapamil, je priporočeni odmerek 150 mg 1-krat na dan (2 kapsuli po 75 mg).
English: After oral administration, dabigatran etexilate is rapidly absorbed and converted to dabigatran by esterase-catalysed hydrolysis in plasma and in the liver.
Slovenian: Po peroralnem jemanju se hitro absorbira in pretvori v dabigatran s hidrolizo v plazmi in jetrih, ki jo katalizira esteraza.
English: Contact your doctor if you experience indigestion after taking Pradaxa.
Slovenian: Obvestite svojega zdravnika, če imate prebavne motnje po jemanju zdravila Pradaxa.
English: • Moderate renal impairment (30-50 mL/min
Slovenian: • zmerna ledvična okvara (30 -50 ml/min
English: In patients with moderate renal impairment and concomitantly treated with verapamil, a dose reduction of Pradaxa to 75 mg daily should be considered (see sections 4.4 and 4.5).
Slovenian: Pri bolnikih z zmerno ledvično okvaro, ki se sočasno zdravijo z verapamilom, je treba presoditi o zmanjšanju odmerka zdravila Pradaxa na 75 mg na dan (glejte poglavji 4.4 in 4.5).
English: • Prescriber Guide
Slovenian: • Navodilo za predpisovalca
English: The oral bioavailability may be increased by 75 % after a single dose and 37 % at steady state compared to the reference capsule formulation when the pellets are taken without the Hydroxypropylmethylcellulose (HPMC) capsule shell.
Slovenian: Pri peroralnem jemanju se lahko biološka uporabnost po enkratnem odmerku poveča za 75%, v stanju dinamičnega ravnovesja pa za 37%, v primerjavi z referenčno kapsulo, ko pelete jemljemo brez ovoja iz hidroksipropilmetilceluloze (HPMC).
English: The mean CHADS2 and HAS-BLED scores were 1.9 and 1.2, respectively.
Slovenian: Povprečna ocena CHADS2 je bila 1,9, povprečna ocena HAS-BLED pa 1,2.
English: Patients following elective knee replacement surgery single capsule of 110 mg Pradaxa
Slovenian: Bolniki po operativni vstavitvi umetnega kolena ena kapsula po 110 mg zdravila Pradaxa
English: Take special care with Pradaxa
Slovenian: Bodite posebej pozorni pri uporabi zdravila Pradaxa
English: In the three active controlled DVT/PE phase III studies, a higher rate of MI was reported in patients who received dabigatran etexilate than in those who received warfarin: 0.4% vs. 0.2% in the shortterm RE-COVER and RE-COVER II studies; and 0.8% vs. 0.1% in the long-term RE-MEDY trial.
Slovenian: V treh študijah faze III GVT/PE, v katerih so za kontrolo uporabili aktivno zdravilo, je bila stopnja pojavnosti miokardnega infarkta pri bolnikih, ki so jemali dabigatran eteksilat, večja kot pri tistih, ki so prejemali varfarin: 0,4 % v primerjavi z 0,2 % v kratkotrajnih študijah RE-COVER in RE-COVER II ter 0,8 % v primerjavi z 0,1 % v dolgotrajni študiji RE-MEDY (v slednji je bilo povečanje statistično značilno p = 0,022).
English: Pradaxa is available in packs containing 10 x 1, 30 x 1 or 60 x 1 capsules, a multipack containing 3 packs of 60 x 1 hard capsules (180 hard capsules) or a multipack containing 2 packs of 50 x 1 hard capsules (100 hard capsules) in aluminium perforated unit dose blisters.
Slovenian: Zdravilo Pradaxa je na voljo v pakiranjih po 10 x 1, 30 x 1 ali 60 x 1 kapsula, večkratnih pakiranjih s 3 enotami po 60 x 1 trda kapsula (180 trdih kapsul) ali večkratnih pakiranjih z 2 enotama po 50 x 1 trda kapsula (100 trdih kapsul) v perforiranih aluminijastih pretisnih omotih za enkratni odmerek.
English: • Patients with severe renal impairment (CrCL < 30 mL/min)
Slovenian: • bolniki s hudo ledvično okvaro (CrCl < 30 ml/min),
English: In the event of haemorrhagic complications, Pradaxa treatment must be discontinued and the source of bleeding investigated.
Slovenian: Pri zapletih zaradi krvavitve moramo zdravljenje z zdravilom Pradaxa prekiniti in ugotoviti njen izvor.
English: Dabigatran inhibits free thrombin, fibrin-bound thrombin and thrombin-induced platelet aggregation.
Slovenian: Dabigatran zavira prosti trombin, na fibrin vezani trombin in agregacijo trombocitov, ki jo povzroča trombin.
English: Pradaxa is used to prevent the formation of blood clots in the veins after knee or hip replacement surgery in adults.
Slovenian: Zdravilo Pradaxa uporabljamo za preprečevanje nastajanja krvnih strdkov v venah po vstavitvi umetnega kolka ali kolena pri odraslih.
English: • 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.
Slovenian: • sočasno zdravljenje s katerim koli drugim antikoagulantom, npr. nefrakcioniranim heparinom (NFH), nizkomolekularnimi heparini (enoksaparin, dalteparin itd.), derivati heparina (fondaparinuks itd.), oralnimi anitkoagulanti (varfarin, rivaroksabana, apiksaban itd), razen v določenih primerih.
English: Patients with elevated liver enzymes > 2 ULN were excluded in the main trials.
Slovenian: Bolnike s povečanimi jetrnimi encimi na več kot 2-kratno zgornjo mejo normalnih vrednosti (ULN) so iz glavnih kliničnih preskušanj izključili.
English: The recommended doses of Pradaxa and the duration of therapy for primary prevention of venous thromboembolism in orthopaedic surgery are shown in table 1.
Slovenian: Priporočeni odmerki zdravila Pradaxa in trajanje zdravljenja pri primarnem preprečevanju venske trombembolije pri ortopedski operaciji so prikazani v preglednici 1.
English: - The black printing ink contains shellac, iron oxide black and potassium hydroxide.
Slovenian: Sestavine črnega tiskarskega črnila so šelak, črni železov oksid in kalijev hidroksid.
English: • Concomitant treatment with the following strong P-gp inhibitors: systemic ketoconazole, cyclosporine, itraconazole, dronedarone and the fixed-dose combination glecaprevir/pibrentasvir (see section 4.5)
Slovenian: • sočasno zdravljenje z naslednjimi močnimi zaviralci P-gp: sistemskim ketokonazolom, ciklosporinom, itrakonazolom, dronedaronom in fiksno kombinacijo glekaprevirja/pibrentasvirja (glejte poglavje 4.5);
English: In a clinical trial the rate of heart attacks with Pradaxa was numerically higher than with warfarin.
Slovenian: V kliničnem preskušanju je bila stopnja srčnih napadov pri zdravilu Pradaxa številčno večja kot pri varfarinu.
English: Patients on Pradaxa who undergo surgery or invasive procedures are at increased risk for bleeding.
Slovenian: Pri bolnikih, ki jemljejo zdravilo Pradaxa, obstaja med kirurškimi posegi ali invazivnimi postopki povečano tveganje krvavitve.
English: Major or severe bleeding may occur, these constitute the most serious side effects and, regardless of location, may become disabling, life-threatening or even lead to death.
Slovenian: Pojavi se lahko večja ali huda krvavitev, ki je najresnejši neželeni učinek in lahko ne glede na mesto krvavitve povzroči invalidnost, življenjsko ogroženost ali je celo usodna.
English: Close clinical surveillance is recommended in patients with renal impairment.
Slovenian: Za bolnike z ledvično okvaro priporočajo natančen klinični nadzor.
English: Although rare 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.
Slovenian: Čeprav je v kliničnih študijah sicer redka po pogostnosti, se lahko pojavi večja ali huda krvavitev in ne glede na mesto krvavitve lahko povzroči invalidnost, življenjsko ogroženost ali je celo usodna.
English: • That all patients should be provided with a Patient alert card and be counselled about: Signs or symptoms of bleeding and when to seek attention from a health care provider.
Slovenian: • Navodilo, da morajo vsi bolniki prejeti opozorilno kartico za bolnika in da jih je treba poučiti o:
English: Percutaneous coronary intervention (PCI) with stenting (SPAF) Patients with non valvular atrial fibrillation who undergo a PCI with stenting can be treated with Pradaxa in combination with antiplatelets after haemostasis is achieved (see section 5.1).
Slovenian: Bolniki z nevalvularno atrijsko fibrilacijo, ki so imeli PKI z vstavitvijo žilne opornice, se lahko zdravijo z zdravilom Pradaxa v kombinaciji z antitrombotiki, ko je dosežena hemostaza (glejte poglavje 5.1).
English: This includes all bleeding events, which occurred during Pradaxa therapy.
Slovenian: Zajemajo vse krvavitve, ki so se pojavile med zdravljenjem z zdravilom Pradaxa.
English: When a single dose of 75 mg dabigatran etexilate was coadministered simultaneously with a loading dose of 180 mg ticagrelor, the dabigatran AUC and Cmax were increased by 1.73-fold and 1.95-fold, respectively.
Slovenian: Ko so enkratni odmerek dabigatran eteksilata po 75 mg uporabili hkrati s polnilnim odmerkom tikagrelorja po 180 mg, sta se AUC in Cmax dabigatrana povečala za 1,73-krat oziroma 1,95-krat.
English: If you stop taking Pradaxa
Slovenian: Če ste prenehali jemati zdravilo Pradaxa
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).
Slovenian: Razvrščeni so po organskih sistemih in pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
English: The following pictogram illustrates how to take Pradaxa capsules out of the blister
Slovenian: Na spodnjih risbah je prikazano, kako je treba vzeti kapsulo zdravila Pradaxa iz pretisnega omota.
English: • Renal function should be assessed during treatment with Pradaxa at least once a year or more frequently as needed in certain clinical situations when it is suspected that the renal function could decline or deteriorate (e.g. hypovolaemia, dehydration, and in case of concomitant use of certain medicinal products).
Slovenian: • Med zdravljenjem z zdravilom Pradaxa je treba oceniti ledvično delovanje najmanj enkrat letno ali po potrebi pogosteje v nekaterih kliničnih razmerah, v katerih bi se lahko zmanjšalo ali poslabšalo (na primer pri hipovolemiji, dehidraciji in v primeru sočasne uporabe nekaterih zdravil).
English: Management of bleeding complications
Slovenian: Ravnanje pri zapletih zaradi krvavitve
English: • CrCL ≥ 30-< 50 mL/min, VKA should be started 2 days before discontinuing Pradaxa
Slovenian: • CrCl ≥ 30-< 50 ml/min, zdravljenje z antagonistom vitamina K je treba začeti 2 dni pred ukinitvijo zdravila Pradaxa.
English: INFORMATION IN BRAILLE Pradaxa 75 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pradaxa 75 mg
English: Pradaxa treatment (150 mg twice daily) does not need to be interrupted in patients undergoing catheter ablation for atrial fibrillation (see section
Slovenian: Zdravljenja z zdravilom Pradaxa (150 mg dvakrat na dan) pri bolnikih, pri katerih bo izvedena katetrska ablacija zaradi atrijske fibrilacije, ni potrebno prekinjati (glejte poglavje 4.2).
English: Taking too much Pradaxa increases the risk of bleeding.
Slovenian: Če vzamete preveč zdravila Pradaxa, se poveča tveganje za krvavitve.
English: DVT/PE treatment and DVT/PE prevention
Slovenian: Zdravljenje GVT/PE in preprečevanje GVT/PE
English: 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.
Slovenian: Stopnja kombinacije velikih krvavitev/klinično pomembnih krvavitev in stopnja vseh krvavitev je bila na 5-odstotni nominalni ravni alfa značilno nižja pri bolnikih, ki so prejemali placebo, kot pri zdravljenih z zdravilom Pradaxa.
English: INFORMATION IN BRAILLE Pradaxa 110 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pradaxa 110 mg
English: In patients with moderate renal impairment (CrCL 30-50 mL/min), a dose reduction is recommended (see table 1 above and sections 4.4 and 5.1).
Slovenian: Za uporabo pri bolnikih z zmerno ledvično okvaro (CrCl 30-50 ml/min) je priporočeno zmanjšanje odmerka (glejte preglednico 1 zgoraj in poglavji 4.4 in 5.1).
English: Not known (frequency cannot be estimated from the available data): - Difficulty in breathing or wheezing - Hair loss
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): - oteženo dihanje ali piskanje v pljučih, - izpadanje las.
English: No dose adjustment is required (see section 4.2).
Slovenian: Odmerka ni potrebno prilagajati (glejte poglavje 4.2).
English: Recurrent symptomatic VTE and VTE-related death
Slovenian: Ponovitev simptomatične VTE in z njo povezana smrt
English: Ranitidine administration together with Pradaxa had no clinically relevant effect on the extent of absorption of dabigatran.
Slovenian: Ranitidin Sočasno dajanje ranitidina in zdravila Pradaxa ni klinično pomembno vplivalo na obseg absorpcije dabigatrana.
English: Furthermore, Pradaxa is available in packs containing 60 x 1 capsules in aluminium perforated unit dose white blisters.
Slovenian: Nadalje, zdravilo Pradaxa je na voljo v pakiranjih po 60 x 1 kapsula v perforiranih aluminijastih belih pretisnih omotih za enkratni odmerek.
English: Common (may affect up to 1 in 10 people): - A fall in the amount of haemoglobin in the blood (the substance in the red blood cells) - Unusual laboratory test results on liver function
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): - zmanjšanje količine hemoglobina v krvi (snovi v rdečih krvničkah), - spremenjeni laboratorijski testi jetrnega delovanja.
English: Tables 18-19 display results of the primary efficacy and safety endpoint in relevant sub-populations:
Slovenian: V preglednicah 18 in 19 so navedeni podatki o primarnem opazovanem dogodku, na podlagi katerega so ocenili učinkovitost in varnost zdravljenja v ustreznih podpulacijah:
English: Limited data is available in patients < 50 kg (see section 5.2).
Slovenian: O bolnikih s telesno maso pod 50 kg je malo podatkov (glejte poglavje 5.2).
English: Clinical trials for the prevention of thromboembolism in patients with prosthetic heart valves
Slovenian: Klinične študije o preprečevanju trombembolije pri bolnikih z umetnimi srčnimi zaklopkami:
English: single capsule of 75 mg Pradaxa
Slovenian: ena kapsula po 75 mg zdravila Pradaxa
English: Hence, the integrity of the HPMC capsules should always be preserved in clinical use to avoid unintentionally increased bioavailability of dabigatran etexilate (see section 4.2).
Slovenian: Da ne bi prišlo do nenamernega povečanja biološke uporabnosti dabigatran eteksilata, morajo biti kapsule z ovojem iz HPMC v klinični rabi vedno neoporečne (glejte poglavje 4.2).
English: Table 9: Other interactions
Slovenian: Preglednica 9: Druga medsebojna delovanja
English: The study compared 150 mg twice daily uninterrupted dabigatran etexilate with uninterrupted INR-adjusted warfarin in catheter ablation of paroxysmal or persistent atrial fibrillation.
Slovenian: V študiji so primerjali neprekinjeno uporabo dabigatran eteksilata 150 mg dvakrat na dan in neprekinjeno uporabo varfarina, prilagojenega vrednostim INR, pri katetrski ablaciji paroksizmalne ali persistentne atrijske fibrilacije.
English: Pradaxa 75 mg are hard capsules with an opaque, white cap and an opaque, white body.
Slovenian: Pradaxa 75 mg so trde kapsule z neprozornim, belim pokrovčkom in neprozornim belim telesom.
English: For both surgeries, if haemostasis is not secured, initiation of treatment should be delayed.
Slovenian: Če pri eni ali drugi operaciji ni zagotovljena hemostaza, moramo zdravljenje odložiti.
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
Slovenian: Kinidin so dajali v odmerkih po 200 mg vsako drugo uro do skupnega odmerka 1.000 mg. Dabigatran eteksilat so dajali dvakrat na dan 3 zaporedne dni, tretji dan s kinidinom ali brez njega.
English: Women of childbearing potential should avoid pregnancy during treatment with Pradaxa.
Slovenian: Ženske v rodni dobi ne smejo zanositi med zdravljenjem z zdravilom Pradaxa.
English: • The cap opens by pushing and turning.
Slovenian: • Odprite tako, da pritisnete navzdol in zavrtite.
English: Data for adjudicated major bleeding endpoints are shown in table 12 below.
Slovenian: Podatki o opazovanem dogodku večje krvavitve so v preglednici 12.
English: Table 5: Transporter interactions
Slovenian: Preglednica 5: S prenosom povezane interakcije
English: Incidences (%) Hazard ratio over warfarin (95 % CI) p value superiority p=0.2721
Slovenian: Pojavnost (%) Razmerje ogroženosti v primerjavi z varfarinom (95odstotni IZ) Superiornost, vrednost p p = 0,2721
English: Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease.
Slovenian: Po izničenju učinka dabigatrana so bolniki izpostavljeni tveganju za trombotične dogodke, ki jih lahko povzroči njihova osnovna bolezen.
English: Furthermore a higher risk of MI was seen in patients concomitantly taking ASA plus clopidogrel or clopidogrel alone.
Slovenian: Tveganje miokardnega infarkta je bilo prav tako povečano pri bolnikih, ki so sočasno jemali acetilsalicilno kislino in klopidogrel ali samo klopidogrel.
English: 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).
Slovenian: V preglednici 8 so navedeni neželeni učinki po organskih sistemih in pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
English: For situations when rapid reversal of the anticoagulant effect of Pradaxa is required the specific reversal agent (Praxbind, idarucizumab) antagonizing the pharmacodynamic effect of Pradaxa is available (see section 4.4).
Slovenian: V razmerah, ko je potrebno hitro izničenje angikoagulacijskega učinka zdravila Pradaxa, je na voljo specifična protiučinkovina (zdravilo Praxbind, idarucizumab), ki deluje kot antagonist farmakodinamičnih učinkov zdravila Pradaxa (glejte poglavje 4.4).
English: Dabigatran etexilate is a small molecule prodrug which does not exhibit any pharmacological activity.
Slovenian: Dabigatran eteksilat je predzdravilo v obliki majhne molekule, ki je brez farmakološkega učinka.
English: Dabigatran plasma concentrations observed at 72 hrs were relatively low, between 32.9 ng/mL and 97.2 ng/mL at final doses between 100 mg and 150 mg (gMean dose normalized total dabigatran plasma concentration of 0.493 ng/mL/mg).
Slovenian: Koncentracije dabigatrana v plazmi so bile po 72 urah razmeroma majhne, in sicer med 32,9 ng/ml in 97,2 ng/ml po zadnjih odmerkih, ki so bili od 100 mg do 150 mg (srednja, glede na odmerek normalizirana skupna koncentracija dabigatrana v plazmi 0,493 ng/ml/mg).
English: Table 20: Analysis of first occurrence of stroke or systemic embolism (primary endpoint) during the study period in RE-LY.
Slovenian: Preglednica 20: Analiza prvega pojava možganske kapi ali sistemskega emboličnega dogodka (primarni opazovani dogodek) v študiji RE-LY
English: In 2 large randomized, parallel group, double-blind, dose-confirmatory trials, patients undergoing elective major orthopaedic surgery (one for knee replacement surgery and one for hip replacement surgery) received Pradaxa 75 mg or 110 mg within 1-4 hours of surgery followed by 150 mg or 220 mg once daily thereafter, haemostasis having been secured, or enoxaparin 40 mg on the day prior to surgery and daily thereafter.
Slovenian: V dveh velikih, randomiziranih, dvojno slepih preskušanjih za potrditev odmerka z vzporednima skupinama so bolniki po večji ortopedski operaciji (v prvem preskušanju po vstavitvi umetnega kolena in v drugem umetnega kolka) prejeli zdravilo Pradaxa po 75 mg ali 110 mg 1 do 4 ure po posegu in nato 150 mg ali 220 mg enkrat na dan ob zagotovljeni hemostazi, ali enoksaparin po 40 mg na dan pred operacijo in nato vsak dan po njej.
English: 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).
Slovenian: Primarni opazovani dogodek (velika krvavitev po kriterijih ISTH) je bil opažen pri 5 (1,6 %) bolnikih v skupini, ki je prejemala dabigatran eteksilat, in pri 22 (6,9 %) bolnikih v skupini, ki je prejemala varfarin (razlika tveganj −5,3 %; 95-% IZ −8,4, −2,2; P = 0,0009).
English: The most commonly reported events are bleedings occurring in approximately 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.
Slovenian: Dogodki, o katerih najpogosteje poročajo, so krvavitve, ki so se pojavile pri približno 16,6 % bolnikov z atrijsko fibrilacijo, ki dolgotrajno jemljejo zdravilo za preprečitev možganske kapi in sistemskih emboličnih dogodkov, in pri 14,4 % bolnikov, ki se zdravijo zaradi GVT/PE.
English: Data for adjudicated major bleeding endpoints are shown in table 19 below.
Slovenian: Podatki o opazovanem dogodku večje krvavitve so v preglednici 19.
English: There are no data available for 110 mg twice daily Pradaxa treatment.
Slovenian: O zdravljenju z zdravilom Pradaxa 110 mg dvakrat na dan ni podatkov.
English: Stroke and/or systemic embolism
Slovenian: Možganska kap ali sistemski embolični dogodek
English: Table 11: Adverse reactions
Slovenian: Preglednica 11: Neželeni učinki
English: The recommended dose is 300 mg taken as one 150 mg capsule twice a day.
Slovenian: Priporočeni odmerek je 300 mg, po ena kapsula po 150 mg dvakrat na dan.
English: In the pre- and post-natal study, an increase in foetal mortality was observed at doses that were toxic to the dams (a dose corresponding to a plasma exposure level 4-fold higher than observed in patients).
Slovenian: Študija o obdobju pred porodom in po njem je odkrila povečano umrljivost plodov po odmerkih, ki so bili toksični za samice (odmerkih, pri katerih je izpostavljenost zdravilu v plazmi 4-krat večja kot pri bolnikih).
English: The RE-LY study demonstrated that dabigatran etexilate, at a dose of 110 mg twice daily, is non-inferior to warfarin in the prevention of stroke and systemic embolism in subjects with atrial fibrillation, with a reduced risk of ICH, total bleeding and major bleeding.
Slovenian: Študija RE-LY je pokazala, da je dabigatran eteksilat v odmerku po 110 mg dvakrat na dan, pri preprečevanju možganske kapi in sistemskih emboličnih dogodkov pri bolnikih z atrijsko fibrilacijo enakovreden varfarinu in da zmanjša tveganje intrakranialnih krvavitev, vseh krvavitev in velikih krvavitev.
English: Catheter ablation can be conducted in patients on 150 mg twice daily Pradaxa treatment.
Slovenian: Katetrska ablacija je mogoča pri bolnikih, ki jemljejo zdravilo Pradaxa 150 mg dvakrat na dan.
English: Your doctor has initiated treatment with Pradaxa
Slovenian: Zdravnik vam je predpisal zdravljenje z zdravilom Pradaxa
English: 150 mg Pradaxa once daily taken as 2 capsules of 75 mg
Slovenian: 150 mg zdravila Pradaxa enkrat na dan kot 2 kapsuli po 75 mg
English: Peak plasma concentrations are reached at 6 hours following administration in a postoperative period due to contributing factors such as anaesthesia, GI paresis, and surgical effects independent of the oral medicinal product formulation.
Slovenian: Koncentracije v plazmi so največje 6 ur po aplikaciji v pooperativnem obdobju, kar je posledica pridruženih dejavnikov, kot so anestezija, pareza prebavil in kirurški učinki in ni povezano s peroralno obliko zdravila.