FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on dabigatran concentrations and clinical assessment, the dose was subsequently modified to a target dose of 2.14 (± 10 %) mg/kg of dabigatran etexilate (100 % of the adult dose adjusted for the patient's weight).
Slovenian: Na podlagi koncentracije dabigatrana in klinične ocene so odmerek nato prilagodili ciljnemu odmerku dabigatran eteksilata 2,14 (± 10 %) mg/kg (100 % odmerka za odrasle, prilagojeno bolnikovi telesni masi).
English: 95 % confidence interval Symptomatic DVT 95 % confidence interval Symptomatic PE
Slovenian: 95-odstotni interval zaupanja Simptomatska GVT 95-odstotni interval zaupanja Simptomatska PE
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).
Slovenian: heparin, klopidogrel, prasugrel, tikagrelor, rivaroksaban, acetilsalicilno kislino); - zdravila za zdravljenje glivičnih okužb (npr. ketokonazol, itrakonazol), razen če jih nanašate samo na kožo; - zdravila za zdravljenje motenj srčnega utripa (npr. amiodaron, dronedaron, kinidin, verapamil);
English: Concomitant use of Pradaxa with mild to moderate P-glycoprotein (P-gp) inhibitors, i.e. amiodarone, quinidine or verapamil
Slovenian: Sočasna uporaba zdravila Pradaxa z blagimi do zmernimi zaviralci P-glikoproteina (P-gp), to so amiodaron, kinidin ali verapamil
English: The parenteral anticoagulant should be discontinued and Pradaxa should be started 0-2 hours prior to the time that the next dose of the alternate therapy would be due, or at the time of discontinuation in case of continuous treatment (e.g. intravenous Unfractionated Heparin (UFH)) (see section 4.5).
Slovenian: Parenteralni antikoagulant je treba ukiniti in uvesti zdravilo Pradaxa 0 do 2 uri pred naslednjim rednim odmerkom alternativnega zdravila ali ob njegovi ukinitvi, če ga bolnik prejema neprekinjeno (npr. intravenski nefrakcioniran heparin (NFH)) (glejte poglavje 4.5).
English: However, for patients with high risk of bleeding, a dose reduction of Pradaxa to 220 mg taken as one 110 mg capsule twice daily should be considered (see sections 4.4 and 5.2).
Slovenian: Pri bolnikih z velikim tveganjem za krvavitve pa je potrebno presoditi o zmanjšanju odmerka Pradaxe na 220 mg, po eno kapsulo po 110 mg dvakrat na dan (glejte poglavji 4.4 in 5.2).
English: The dabigatran AUC and Cmax were increased by about 1.6-fold and 1.5-fold, respectively.
Slovenian: AUC dabigatrana se je povečala za približno 1,6-krat, Cmax pa za približno 1,5-krat.
English: Risk difference vs. warfarin (%)
Slovenian: Razlika med ogroženostmi v primerjavi z varfarinom (%)
English: Other dabigatran related anti-coagulation tests were not changed significantly by the pre-treatment of enoxaparin.
Slovenian: Na druge antikoagulacijske teste povezane z uporabo dabigatrana pa predzdravljenje z enoksaparinom ni pomembneje vplivalo.
English: Not known (frequency cannot be estimated from the available data): - Difficulty in breathing or wheezing - A fall in the amount of haemoglobin in the blood (the substance in the red blood cells) - A fall in the number of red cells in the blood - Yellowing of the skin or whites of the eyes, caused by liver or blood problems - Hair loss
Slovenian: Neznana pogostnost (ki je ni mogoče oceniti po razpoložljivih podatkih): - oteženo dihanje ali piskanje v pljučih, - zmanjšanje količine hemoglobina v krvi (snovi v rdečih krvničkah), - zmanjšanje števila rdečih krvničk v krvi, - porumenela koža ali beločnice zaradi jetrnih ali krvnih motenj, - izpadanje las.
English: There are no data available for 110 mg twice daily Pradaxa treatment in patients undergoing catheter ablation for atrial fibrillation (see section 4.2).
Slovenian: O zdravljenju z zdravilom Pradaxa 110 mg dvakrat na dan pri bolnikih, pri katerih bo izvedena katetrska ablacija zaradi atrijske fibrilacije, ni podatkov (glejte poglavje 4.2).
English: Pradaxa 150 mg
Slovenian: Zdravilo Pradaxa 150 mg
English: Posaconazole Posaconazole also inhibits P-gp to some extent but has not been clinically studied.
Slovenian: Do določene mere zavira P-gp tudi posakonazol, vendar ta učinek ni klinično raziskan.
English: Possible side effects are listed below, grouped by how likely they are to happen.
Slovenian: Možni neželeni učinki so razvrščeni po pogostnosti pojavljanja.
English: Do not break, chew, or empty the pellets from the capsule.
Slovenian: Kapsule ne smete zlomiti, žvečiti ali iz nje izprazniti zrnc.
English: Transporter interactions
Slovenian: S prenosom povezane interakcije
English: It is recommended to wait 12 hours after the last dose before switching from Pradaxa to a parenteral anticoagulant (see section 4.5).
Slovenian: Priporočljivo je počakati 12 ur po zadnjem odmerku, preden boste zamenjali zdravilo Pradaxa s parenteralnim antikoagulantom (glejte poglavje 4.5).
English: Furthermore, bleeding occurred in 19.4 % of patients in the DVT/PE prevention trial RE-MEDY and in 10.5 % of patients in the DVT/PE prevention trial RE-SONATE.
Slovenian: Nadalje se je krvavitev pojavila pri 19,4 % bolnikov, ki so zdravilo jemali za preprečitev GVT/PE v preskušanju RE-MEDY, in pri 10,5 % bolnikov, ki so zdravilo jemali za preprečitev GVT/PE v preskušanju RE-SONATE.
English: Major:
Slovenian: Glavni:
English: The ECT was not measured in patients treated for prevention of VTEs after hip or knee replacement surgery with 220 mg dabigatran etexilate once daily.
Slovenian: EKT niso merili bolnikom, ki so prejemali za preprečitev venske trombembolije po operativni vstavitvi umetnega kolka ali kolena po 220 mg dabigatran eteksilata na dan.
English: At the end of the follow-up VTE events in patients treated with dabigatran etexilate was 6.9 % vs. 10.7 % among the placebo group (hazard ratio 0.61 (95% CI 0.42, 0.88), p=0.0082).
Slovenian: Ob koncu obdobja sledenja je bil odstotek venskih trombembolij pri bolnikih, ki so se zdravili z dabigatran eteksilatom 6,9 %, v skupini, ki je jemala placebo, pa 10,7 % (razmerje ogroženosti 0,61 (95-odstotni interval zaupanja 0,42, 0,88), p = 0,0082).
English: th percentile of dabigatran plasma concentrations was 67 ng/mL, measured at trough (20-28 hours after the previous dose) (see section 4.4 and 4.9),
Slovenian: • 90. percentil koncentracij dabigatrana v plazmi 67 ng/ml, izmerjen pri najmanjši vrednosti (20 do 28 ur po prejšnjem odmerku) (glejte poglavji 4.4 in 4.9);
English: A prospective, randomized, open-label, blinded endpoint (PROBE) study (Phase IIIb) to evaluate dual-therapy with dabigatran etexilate (110 mg or 150 mg bid) plus clopidogrel or ticagrelor (P2Y12 antagonist) vs. triple-therapy with warfarin (adjusted to a INR 2.0 - 3.0) plus clopidogrel or ticagrelor and aspirin was conducted in 2725 patients with non valvular atrial fibrillation who underwent a PCI with stenting (RE-DUAL PCI).
Slovenian: Prospektivno, randomizirano, odprto, slepo študijo z opazovanim dogodkom (PROBE) (faze IIIb) za ocenitev dvojne terapije z dabigatran eteksilatom (110 mg ali 150 mg dvakrat na dan) plus klopidogrel ali tikagrelor (antagonist P2Y12) v primerjavi strojno terapijo z varfarinom (prilagojeno za INR 2,03,0) plus klopidogrel ali tikagrelor in acetilsalicilna kislina, so izvedli pri 2.725 bolnikih z nevalvularno atrijsko fibrilacijo, ki so imeli PKI z vstavitvijo žilne opornice (RE-DUAL PCI).
English: • the 90th percentile of aPTT at trough (10-16 hours after the previous dose) was 62 seconds, which would be 1.8-fold compared to baseline.
Slovenian: • 90. percentil aPTČ pred naslednjim odmerkom (10 do 16 ur po prejšnjem odmerku) je bil 62 sekund, kar bi bilo 1,8-kratno v primerjavi z izhodiščno vrednostjo.
English: For treatment of DVT and PE, with dabigatran etexilate 150 mg twice daily,
Slovenian: Pri zdravljenju GVT in PE z dabigatran eteksilatom po 150 g dvakrat na dan,
English: For subjects with gastritis, esophagitis, or gastroesophageal reflux, a dose reduction may be considered due to the elevated risk of major gastro-intestinal bleeding (see table 1 above and section 4.4).
Slovenian: Pri bolnikih z gastritisom, ezofagitisom ali gastroezofagealnim refluksom je treba zaradi povečanega tveganja velike krvavitve v prebavilih presoditi o zmanjšanju odmerka (glejte preglednico 1 zgoraj in poglavje 4.4).
English: It is recommended to wait 24 hours after the last dose before switching from Pradaxa to a parenteral anticoagulant (see section 4.5).
Slovenian: Priporočljivo je počakati 24 ur po zadnjem odmerku, preden boste zamenjali zdravilo Pradaxa s parenteralnim antikoagulantom (glejte poglavje 4.5).
English: Pradaxa ® Information for Healthcare Professionals
Slovenian: Informacije za zdravstvene delavce • Zdravilo Pradaxa
English: The recommended dose is 220 mg once a day (taken as 2 capsules of 110 mg).
Slovenian: Priporočeni odmerek je 220 mg enkrat na dan (to sta dve kapsuli po 110 mg).
English: Pradaxa 220 mg
Slovenian: Zdravilo Pradaxa 220 mg
English: The most commonly reported events are bleedings occurring in approximately 14 % of patients treated short-term for elective hip or knee replacement surgery, 16.6 % in patients with atrial fibrillation treated long-term for the prevention of stroke and systemic embolism, and in 14.4 % of patients treated for DVT/PE.
Slovenian: Dogodki, o katerih najpogosteje poročajo, so krvavitve, ki so se pojavile pri približno 14 % bolnikov, ki se kratkotrajno zdravijo v sklopu operativne vstavitve umetnega kolka ali kolena, pri 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: 2-3 days before
Slovenian: 2-3 dni pred
English: • Do not peel off the blister foil until a capsule is required.
Slovenian: • Pretisno folijo odlepite šele, ko boste potrebovali kapsulo.
English: Pradaxa 220 mg once daily
Slovenian: Zdravilo Pradaxa 220 mg enkrat dnevno
English: INFORMATION IN BRAILLE Pradaxa 75 mg (only applicable for folding box, not applicable for bottle label)
Slovenian: PODATKI V BRAILLOVI PISAVI PRADAXA 75 mg (velja samo za škatlo, ne velja za nalepko na plastenki)
English: There is a clear correlation between plasma dabigatran concentration and degree of anticoagulant effect based on phase II studies.
Slovenian: Študije faze II so pokazale, da je med plazemsko koncentracijo dabigatrana in stopnjo antikoagulacijskega učinka jasna korelacija.
English: 2 days before
Slovenian: 2 dni pred
English: UFH can be administered at doses necessary to maintain a patent central venous or arterial catheter or during catheter ablation for atrial fibrillation (see section 4.3).
Slovenian: NFH smemo dajati v odmerkih, ki so potrebni za vzdrževanje prehodnosti centralnega venskega ali arterijskega katetra ali med katetrsko ablacijo zaradi atrijske fibrilacije (glejte poglavji 4.3).
English: How to take Pradaxa
Slovenian: Kako jemati zdravilo Pradaxa
English: In vivo and ex vivo animal studies have demonstrated antithrombotic efficacy and anticoagulant activity of dabigatran after intravenous administration and of dabigatran etexilate after oral administration in various animal models of thrombosis.
Slovenian: Študije na živalih in vivo ter ex vivo so na različnih živalskih modelih tromboze pokazale, da delujeta dabigatran po intravenskem in dabigatran eteksilat po peroralnem vnosu antitrombotično in antikoagulacijsko.
English: 2015;131:157-164] in more than 134,000 elderly patients with NVAF in the United States (contributing more than 37,500 patientyears of on-therapy follow-up time) dabigatran etexilate (84 % patients treated with 150 mg bid, 16 % patients treated with 75 mg bid) was associated with a reduced risk of ischemic stroke (hazard ratio 0.80, 95 % confidence interval [CI] 0.67 - 0.96), intracranial haemorrhage (hazard ratio 0.34, CI 0.26 - 0.46), and mortality (hazard ratio 0.86, CI 0.77 - 0.96) and increased risk of gastrointestinal bleeding (hazard ratio 1.28, CI 1.14 - 1.44) compared to warfarin.
Slovenian: 2015;131:157-164] pri več kot 134.000 starejših bolnikih z NVAF v Združenih državah (čas spremljanja z zdravljenjem je znašal več kot 37.500 bolnik-let), je bil dabigatran eteksilat (84 % bolnikov zdravljenih s 150 mg dvakrat na dan, 16 % bolnikov zdravljenih s 75 mg dvakrat na dan) povezan z zmanjšanjem tveganja za ishemično možgansko kap (razmerje tveganja 0,80, 95-% interval zaupanja [IZ] 0,67-0,96), intrakranialno krvavitev (razmerje tveganja 0,34, IZ 0,26-0,46) in umrljivost (razmerje tveganja 0,86, IZ 0,77-0,96) ter s povečanjem tveganja za gastrintestinalne krvavitve (razmerje tveganja 1,28, IZ 1,14-1,44), v primerjavi z varfarinom.
English: In the trial program the rate of heart attacks with Pradaxa was higher than with warfarin.
Slovenian: V sklopu programa kliničnega preskušanja je bila stopnja srčnih napadov pri zdravilu Pradaxa večja kot pri varfarinu.
English: For subjects with gastritis, esophagitis, or gastroesophageal reflux, a dose reduction may be considered due to the elevated risk of major gastro-intestinal bleeding (see table 2 above and section 4.4).
Slovenian: Pri bolnikih z gastritisom, ezofagitisom ali gastroezofagealnim refluksom je treba zaradi povečanega tveganja velike krvavitve v prebavilih presoditi o zmanjšanju odmerka (glejte preglednico 2 zgoraj in poglavje 4.4).
English: Capsules with white, opaque cap and white, opaque body of size 2 filled with yellowish pellets.
Slovenian: Kapsule z belim, neprozornim pokrovčkom in belim telesom, velikosti 2, napolnjene z rumenkastimi peletami.
English: Subacute surgery/interventions
Slovenian: Subakutna operacija ali subakutne intervencije
English: If you are a woman of child-bearing age, you should avoid becoming pregnant while you are taking Pradaxa.
Slovenian: Če ste ženska v rodni dobi, se morate med zdravljenjem z zdravilom Pradaxa izogibati zanositvi.
English: Clinical trials in Venous Thromboembolism (VTE) prophylaxis following major joint replacement surgery
Slovenian: Klinična preskušanja pri profilaksi venske trombembolije (VTE) po operativni vstavitvi večjega umetnega sklepa
English: When dabigatran etexilate (150 mg) was co-administered with oral verapamil, the Cmax and AUC of dabigatran were increased but the magnitude of this change differs depending on timing of administration and formulation of verapamil (see sections 4.2 and 4.4).
Slovenian: Ob sočasnem dajanju dabigatran eteksilata (150 mg) in peroralnega verapamila, sta se dabigatranovi vrednosti Cmax in AUC povečali, pri čemer je bila velikost te spremembe različna in odvisna od časa dajanja in oblike verapamila (glejte poglavji 4.2 in 4.4).
English: Incidences (%) Risk ratio over enoxaparin 95 % CI
Slovenian: Pojavnost (%) Razmerje tveganja glede na enoksaparin 95 % CI
English: Any bleeding
Slovenian: krvavitev,
English: - if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C - if you have received an artificial heart valve which requires permanent blood thinning.
Slovenian: - če jemljete peroralni ciklosporin, zdravilo za preprečitev zavrnitve organa po presaditvi; - če jemljete dronedaron, zdravilo za zdravljenje motenj srčnega utripa; - če jemljete zdravila, ki vsebujejo kombinacijo glekaprevirja in pibrentasvirja, protivirusno zdravilo za zdravljenje hepatitisa C; - če so vam vstavili umetno srčno zaklopko, kar zahteva stalno redčenje krvi.
English: There is no or only limited experience with the following treatments which may increase the risk of bleeding when used concomitantly with Pradaxa: anticoagulants such as unfractionated heparin (UFH), low molecular weight heparins (LMWH), and heparin derivatives (fondaparinux, desirudin), thrombolytic medicinal products, and vitamin K antagonists, rivaroxaban or other oral anticoagulants (see section 4.3), and antiplatelet aggregation medicinal products such as GPIIb/IIIa receptor antagonists, ticlopidine, prasugrel, ticagrelor, dextran, and sulfinpyrazone (see section 4.4).
Slovenian: Ni izkušenj ali je malo izkušenj z jemanjem naslednjih zdravil, ki lahko povečajo tveganje krvavitve, če se jih uvede sočasno z zdravilom Pradaxa: antikoagulanti, kot so nefrakcionirani heparin (NFH), nizkomolekularni heparini (NMH) in derivati heparina (fondaparinuksa, desirudina); trombolitiki in antagonisti vitamina K, rivaroksaban ali drugi peroralni antikoagulanti (glejte poglavje 4.3) ter zaviralci agregacije trombocitov, kot so antagonisti receptorjev GPIIb/IIIa, tiklopidin, prasugrel, tikagrelor, dekstran in sulfinpirazon (glejte poglavje 4.4).
English: Depending on the clinical situation appropriate supportive treatment, such as surgical haemostasis and blood volume replacement, should be undertaken at the prescriber's discretion.
Slovenian: Glede na klinično situacijo naj zdravnik, ki je zdravilo predpisal, uvede ustrezno podporno zdravljenje, kot je kirurška hemostaza in nadomeščanje krvnega volumna.
English: When severe bleedings occur, treatment must be discontinued, the source of bleeding investigated and use of the specific reversal agent Praxbind (idarucizumab) may be considered (see section 4.9 Management of bleeding complications).
Slovenian: Če se pojavi huda krvavitev, moramo zdravljenje ukiniti, preiskati izvor krvavitve in presoditi o morebitni uporabi specifične protiučinkovine idarucizumab (zdravilo Praxbind) (glejte poglavje 4.9 Ravnanje pri zapletih zaradi krvavitve).
English: Table 12: Number (%) of patients experiencing the adverse reaction bleeding
Slovenian: Preglednica 12: Število (%) bolnikov, ki so imeli neželeni učinek v obliki krvavitve
English: Pradaxa should be restarted after the invasive procedure or surgical intervention as soon as possible provided the clinical situation allows and adequate haemostasis has been established.
Slovenian: Zdravilo Pradaxa moramo po invazivnem postopku ali kirurškem posegu ponovno uvesti takoj, ko nam klinične razmere omogočajo in je vzpostavljena primerna hemostaza.
English: ® safely, please consider the important information inside.
Slovenian: ® upoštevate pomembne informacije na tej kartici.
English: Table 1: Dose recommendations for SPAF, DVT and PE Dose recommendation
Slovenian: Preglednica 1: Priporočila o odmerjanju pri SPAF, GVT in PE Priporočilo o odmerjanju
English: Any GI bleeds *HR not estimable as there is no event in either one cohort/treatment
Slovenian: Vse krvavitve v prebavilih *Razmerja ogroženosti ni mogoče oceniti, ker v nobeni kohortni skupini oziroma pri nobenem zdravilu ni bilo nikakršnega dogodka.
English: There is no relevant use of Pradaxa in the paediatric population for the indication of primary prevention of venous thromboembolic events in patients who have undergone elective total hip replacement surgery or total knee replacement surgery.
Slovenian: Pri pediatrični populaciji ni ustrezne uporabe zdravila Pradaxa za indikacijo primarno preprečevanje venskih trombemboličnih dogodkov pri bolnikih po operativni vstavitvi umetnega kolka ali kolena.
English: If not otherwise specifically described, close clinical surveillance (looking for signs of bleeding or anaemia) is required when dabigatran is co-administered with strong P-gp inhibitors.
Slovenian: Če ni posebej opisano drugače, je treba sočasno dajanje dabigatrana in močnih zaviralcev P-gp natančno klinično spremljati (zaradi odkrivanja znakov krvavitve ali anemije).
English: For patients with moderate renal impairment (CrCL 30-50 mL/min) the recommended dose of Pradaxa is also 300 mg taken as one 150 mg capsule twice daily.
Slovenian: Priporočeni odmerek zdravila Pradaxa za bolnike z zmerno ledvično okvaro (CrCl 30-50 ml/min) je prav tako 300 mg, po eno kapsulo po 150 mg dvakrat na dan.
English: In patients treated for DVT and PE with 150 mg dabigatran etexilate twice daily, the dabigatran geometric mean trough concentration, measured within 10−16 hours after dose, at the end of the dosing interval (i.e. 12 hours after the 150 mg dabigatran evening dose), was 59.7 ng/ml, with a range of 38.6 - 94.5 ng/ml (25th-75th percentile range).
Slovenian: Pri bolnikih, ki so se zdravili zaradi GVT in PE s 150 mg dabigatran eteksilata dvakrat na dan, je geometrična sredina koncentracije pred naslednjim odmerkom, izmerjena v 10 do 16 urah po odmerku, ob koncu odmernega intervala (tj. 12 ur po večernem odmerku dabigatrana po 150 mg) znašala 59,7 ng/ml, njen razpon pa je bil 38,6 do 94,5 ng/ml (razpon 25. do 75. percentil).
English: Table 9: Number (%) of patients experiencing the adverse reaction bleeding
Slovenian: Preglednica 9: Število (%) bolnikov, ki so imeli neželeni učinek v obliki krvavitve
English: th percentile of aPTT at trough (20-28 hours after the previous dose) was 51 seconds, which would be 1.3-fold upper limit of normal.
Slovenian: • 90. percentil aPTČ pri najmanjši vrednosti (20 do 28 ur po prejšnjem odmerku) 51 sekund, kar naj bi bila 1,3-kratna zgornja meja normalne vrednosti.
English: Patients undergoing catheter ablation for atrial fibrillation
Slovenian: Katetrska ablacija pri bolnikih z atrijsko fibrilacijo
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.
Slovenian: O uporabi fibrinolitičnih zdravil za zdravljenje akutne ishemične možganske kapi je treba presoditi, če bolnikove vrednosti dTT, EKT ali aPTČ niso večje od zgornje meje normalne vrednosti glede na lokalni razpon referenčnih vrednosti.
English: Half-life is prolonged if renal function is impaired as shown in table 23.
Slovenian: Pri okvarjenem ledvičnem delovanju je razpolovna doba podaljšana, kot je navedeno v preglednici 23.
English: Capsules with light blue, opaque cap and light blue, opaque body of size 1 filled with yellowish pellets.
Slovenian: Kapsule s svetlo modrim, neprozornim pokrovčkom in svetlo modrim telesom, velikosti 1, napolnjene z rumenkastimi peletami.
English: Table 7: Transporter interactions
Slovenian: Preglednica 7: S prenosom povezane interakcije
English: INFORMATION IN BRAILLE Pradaxa 110 mg (only applicable for folding box, not applicable for bottle label)
Slovenian: PODATKI V BRAILLOVI PISAVI Pradaxa 110 mg (velja samo za škatlo, ne velja za nalepko na plastenki)
English: Subjects randomized Major bleeding Intracranial bleeding GI bleeding Fatal bleeding Minor bleeding Any bleeding
Slovenian: Naključno razvrščeni bolniki Velika krvavitev Intrakranialna krvavitev Krvavitev v prebavilih Usodna krvavitev Manjša krvavitev Vse krvavitve
English: In the RE-LY study, a total of 18,113 patients were randomized, with a mean age of 71.5 years and a mean CHADS2 score of 2.1.
Slovenian: Povprečna starost bolnikov je bila 71,5 leta, povprečna ocena CHADS2 pa 2,1.
English: Surgical and medical procedures Wound drainage
Slovenian: Kirurški in drugi medicinski posegi
English: After oral administration of Pradaxa in healthy volunteers, the pharmacokinetic profile of dabigatran in plasma is characterized by a rapid increase in plasma concentrations with Cmax attained within 0.5 and 2.0 hours post administration.
Slovenian: Po peroralni aplikaciji zdravila Pradaxa pri zdravih prostovoljcih je za farmakokinetiko dabigatrana v plazmi značilno hitro povečanje njegove koncentracije v plazmi -Cmax doseže med 0,5 in 2,0 ure po aplikaciji.
English: • Patient Alert Cards
Slovenian: • Opozorilno kartico za bolnika
English: Myocardial infarction rates were slightly increased with dabigatran etexilate 110 mg twice daily and 150 mg twice daily compared to warfarin (hazard ratio 1.29; p=0.0929 and hazard ratio 1.27; p=0.1240, respectively).
Slovenian: V primerjavi z varfarinom so bile pri jemanju dabigatran eteksilata v odmerkih po 110 mg dvakrat na dan in 150 mg dvakrat na dan stopnje miokardnih infarktov nekoliko večje (razmerje tveganja 1,29; p = 0,0929 oziroma razmerje tveganja 1,27; p = 0,1240).
English: The most commonly reported events are bleedings occurring in approximately 14 % of patients; the frequency of major bleeds (including wound site bleedings) is less than 2 %.
Slovenian: Pogostnost večjih krvavitev (tudi krvavitev iz rane) je manjša od 2 %.