FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale toksične vplive na sposobnost razmnoževanja (glejte poglavje 5.3).
English: This has been confirmed by in vivo studies with healthy volunteers, who did not show any interaction between this treatment and the following active substances: atorvastatin (CYP3A4), digoxin (P-gp transporter interaction) and diclofenac (CYP2C9).
Slovenian: To so potrdile študije in vivo pri zdravih prostovoljcih, pri katerih ni bilo nikakršnih interakcij zdravila z naslednjimi zdravilnimi učinkovinami: atorvastatinom (CYP3A4), digoksinom (interakcija s prenosnim P-gp) in diklofenakom (CYP2C9).
English: CrCL(mL/min) 30 ≤ and < 50 50 ≤ and < 80
Slovenian: CrCl (ml/min) 30 ≤ in < 50 50 ≤ in < 80
English: A dose reduction is recommended as indicated in section 4.2.
Slovenian: Priporočeno je zmanjšanje odmerka, kot je navedeno v poglavju 4.2.
English: Do not stop taking Pradaxa without talking to your doctor first, because the risk of developing a blood clot could be higher if you stop treatment too early.
Slovenian: Ne prenehajte jemati zdravila Pradaxa, ne da bi se najprej posvetovali z zdravnikom, saj se lahko nevarnost pojava krvnega strdka poveča, če zdravljenje ustavite prezgodaj.
English: It is very important to take Pradaxa before and after the operation exactly at the times you have been told by your doctor.
Slovenian: Zelo pomembno je, da zdravilo Pradaxa vzamete pred in po operaciji točno takrat, ko vam naroči zdravnik.
English: - if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed.
Slovenian: - če veste, da imate bolezen, imenovano antifosfolipidni sindrom (bolezen imunskega sistema, zaradi katere imate povečano tveganje za nastanek krvnih strdkov), o tem obvestite zdravnika, ki bo presodil, ali je treba zdravljenje spremeniti.
English: Laboratory coagulation parameters
Slovenian: Laboratorijski parametri za koagulacijo
English: Relative risk was highest in patients ≥ 75 years.
Slovenian: Relativno tveganje je bilo največje pri bolnikih starih 75 let in več.
English: Assessment of renal function prior to and during Pradaxa treatment
Slovenian: Ocena ledvičnega delovanja pred in med zdravljenjem z zdravilom Pradaxa
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu/
English: ® is mainly eliminated by the kidneys; adequate diuresis must be maintained.
Slovenian: ® se izloča predvsem skozi ledvice; zagotovljena mora biti zadostna diureza.
English: Therefore, related medicinal product interactions are not expected with dabigatran.
Slovenian: Zato tovrstnih interakcij z drugimi zdravili pri dabigatranu ne pričakujemo.
English: The MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authority prior to distribution of the educational pack.
Slovenian: Imetnik dovoljenja za promet z zdravilom se mora s prisotnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnega gradiva ter o načrtu razdeljevanja, in sicer pred razdeljevanjem izobraževalnega gradiva.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Slovenian: • Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1;
English: • Recommendation for kidney function measurement
Slovenian: • Priporočilo za merjenje ledvičnega delovanja
English: The efficacy and safety was investigated in two multi-center, randomised, double blind, parallelgroup, replicate studies RE-COVER and RE-COVER II.
Slovenian: Učinkovitost in varnost so proučili v dveh multicentričnih, dvojno slepih, replikacijskih študijah s paralelnimi skupinami naključno izbranih bolnikov, RE-COVER in RE-COVER II.
English: A prospective, randomized, open-label, multicenter, exploratory study with blinded, centrally adjudicated endpoint evaluation (RE-CIRCUIT) was conducted in 704 patients who were under stable anticoagulant treatment.
Slovenian: Prospektivna, randomizirana, odprta, multicentrična raziskovalna študija s slepo centralno oceno opazovanega dogodka (RE-CIRCUIT) je vključevala 704 bolnike, ki so prejemali stabilno antikoagulacijsko zdravljenje.
English: In the studied patient population of RE-MODEL and RE-NOVATE (5,539 patients treated), 51 % suffered from concomitant hypertension, 9 % from concomitant diabetes, 9 % from concomitant coronary artery disease and 20 % had a history of venous insufficiency.
Slovenian: V populaciji bolnikov v študijah RE-MODEL in RE-NOVATE (5539 zdravljenih bolnikov) je imelo 51 % bolnikov sočasno hipertenzijo, 9 % sladkorno bolezen, 9 % koronarno arterijsko bolezen in 20 % vensko insufucienco v anamnezi.
English: Procedures such as spinal anaesthesia may require complete haemostatic function.
Slovenian: Pri postopkih, kot je spinalna anestezija, je potrebna popolna hemostazna funkcija.
English: What Pradaxa is and what it is used for
Slovenian: Kaj je zdravilo Pradaxa in za kaj ga uporabljamo
English: The median CrCL in the RE-MEDY and RE-SONATE studies were 99.0 mL/min and 99.7 mL/min, respectively.
Slovenian: V študijah RE-MEDY in RE-SONATE sta bili mediani CrCl 99,0 ml/min oziroma 99,7 ml/min.
English: prevent blood clots in the brain (stroke) and other blood vessels in the body if you have a form of irregular heart rhythm called nonvalvular atrial fibrillation and at least one additional risk factor.
Slovenian: - preprečevanje krvnih strdkov v možganih (kap) in drugih žilah v telesu, če imate obliko nepravilnega bitja srca, ki se imenuje atrijska fibrilacija in vsaj en dodaten dejavnik tveganja;
English: Dabigatran etexilate and dabigatran are not metabolised by the cytochrome P450 system and have no in vitro effects on human cytochrome P450 enzymes.
Slovenian: Dabigatran eteksilat in dabigatran se ne presnavljata prek sistema citokroma P450 ter in vitro ne vplivata na encime človeškega citokroma P450.
English: Factors increasing dabigatran plasma levels
Slovenian: Dejavniki, ki povečajo raven dabigatrana v plazmi
English: In such cases a coagulation test (see sections 4.4 and 5.1) may help to determine whether haemostasis is still impaired.
Slovenian: V teh primerih lahko s koagulacijskim testom (glejte poglavji 4.4 in 5.1) preverimo, ali je hemostaza še neustrezna.
English: In actively controlled VTE prevention trials 6,684 patients were treated with 150 mg or 220 mg Pradaxa daily.
Slovenian: V aktivno nadzorovanih preskušanjih zdravila pri preprečevanju VTE so 6684 bolnikov zdravili s 150 ali 220 mg zdravila Pradaxa na dan.
English: 24 hours before
Slovenian: 24 ur pred
English: In a small number of volunteers with severe renal insufficiency (CrCL 10-30 mL/min), the exposure (AUC) to dabigatran was approximately 6 times higher and the half-life approximately 2 times longer than that observed in a population without renal insufficiency (see sections 4.2, 4.3 and 4.4).
Slovenian: Pri majhnem številu prostovoljcev s hudo ledvično insuficienco (CrCl 10 do 30 ml/min) je bila izpostavljenost (AUC) dabigatranu približno 6-krat večja in njegova razpolovna doba približno 2-krat daljša kot v populaciji brez ledvične insuficience (glejte poglavja 4.2, 4.3 in 4.4).
English: If you experience any bleeding event that does not stop by itself or if you experience signs of excessive bleeding (exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling) consult your doctor immediately.
Slovenian: Če boste imeli krvavitev, ki se ne bo zaustavila, ali znake prekomerne krvavitve (neobičajna oslabelost, utrujenost, bledica, omotica, glavobol ali nepojasnjeno otekanje) se nemudoma posvetujte s svojim zdravnikom.
English: Postoperative phase
Slovenian: Pooperativno obdobje
English: The volume of distribution of dabigatran of 60-70 L exceeded the volume of total body water indicating moderate tissue distribution of dabigatran.
Slovenian: Volumen porazdelitve dabigatrana, ki je 60 do 70 l, je bil večji od volumna skupne vode v telesu, kar kaže na zmerno porazdelitev dabigatrana v tkivih.
English: • Low body weight (< 50 kg)
Slovenian: Manj pomembni: • majhna telesna masa (< 50 kg)
English: Use of fibrinolytic medicinal products for the treatment of acute ischemic stroke
Slovenian: Uporaba fibrinolitičnih zdravil za zdravljenje akutne ishemične možganske kapi
English: Patients who receive concomitant verapamil*, amiodarone, quinidine
Slovenian: Bolniki, ki sočasno prejemajo verapamil*, amiodaron, kinidin
English: The duration of treatment with fixed dose of dabigatran was 174.0 days without coagulation monitoring.
Slovenian: Zdravljenje s fiksnim odmerkom dabigatrana brez spremljanja koagulacije je trajalo 174,0 dni.
English: The inducing effect was diminished resulting in dabigatran exposure close to the reference by day 7 after cessation of rifampicin treatment.
Slovenian: Indukcijski učinek se je zmanjšal, kar je povzročilo, da se je izpostavljenost dabigatranu do 7. dne po ukinitvi rifampicina približala referenčni izpostavljenosti.
English: Close clinical surveillance
Slovenian: Natančen kliničen nadzor
English: You should not take Pradaxa if you are pregnant unless your doctor advises you that it is safe to do so.
Slovenian: Če ste noseči, zdravila Pradaxa ne smete jemati, razen če vam zdravnik pove, da je jemanje varno.
English: Do not use this medicine after the expiry date which is stated on the carton, blister or bottle after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, pretisnem omotu ali plastenki, poleg oznake “EXP”.
English: Pradaxa is for oral use.
Slovenian: Zdravilo Pradaxa je za peroralno uporabo.
English: These patients require frequent observation for neurological signs and symptoms of spinal or epidural haematoma.
Slovenian: Bolnike je treba pogosto spremljati, da bi odkrili nevrološke znake in simptome spinalnih ali epiduralnih hematomov.
English: After discontinuation of study medication the effect was maintained until the end of the follow-up, indicating that the initial treatment effect of dabigatran etexilate was sustained.
Slovenian: Po ukinitvi preskušanega zdravila se je njegov učinek ohranil do konca opazovalnega obdobja, kar kaže, da je začetni učinek dabigatrana še trajal.
English: Catheter ablation for atrial fibrillation (SPAF)
Slovenian: Katetrska ablacija zaradi atrijske fibrilacije (SPAF)
English: Effects observed in the repeated dose toxicity studies were due to the exaggerated pharmacodynamic effect of dabigatran.
Slovenian: Učinki, ki so jih zasledili v študijah toksičnosti ponavljajočih odmerkov, so bili posledica prekomernega farmakodinamičnega učinka dabigatrana.
English: Contact your doctor immediately if you have taken too many Pradaxa capsules.
Slovenian: Takoj se obrnite na svojega zdravnika, če ste vzeli preveč kapsul zdravila Pradaxa.
English: There was no influence on male fertility.
Slovenian: Ni bilo vpliva na plodnost samcev.
English: It works by blocking a substance in the body which is involved in blood clot formation.
Slovenian: Deluje tako, da v telesu zavira snov, ki sodeluje pri nastanku krvnega strdka.
English: • Strong P-gp inhibitors (see section 4.3 and
Slovenian: • močni zaviralci P-gp (glejte poglavji 4.3 in
English: The educational pack must be available for distribution for all therapeutic indications prior to launch ) in the Member State.
Slovenian: Izobraževalno gradivo za vse terapevtske indikacije mora biti pripravljeno za razdeljevanje pred prihodom na trg v posamezni državi članici.
English: Selective serotonin re-uptake inhibitors (SSRIs) or selective serotonin norepinephrine re-uptake inhibitors (SNRIs)
Slovenian: Selektivni zaviralci ponovnega privzema serotonina (SSRI) ali selektivni zaviralci ponovnega privzema serotonina in noradrenalina (SNRI)
English: There is some experimental evidence to support the role of these medicinal products in reversing the anticoagulant effect of dabigatran, but data on their usefulness in clinical settings and also on the possible risk of rebound thromboembolism is very limited.
Slovenian: Na voljo je nekaj eksperimentalnih podatkov, ki kažejo na možen pomen teh zdravil pri odpravi antikoagulacijskega učinka dabigatrana, zelo malo podatkov pa je o njihovi uporabnosti v klinični rabi in možnem tveganju povratne trombembolije.
English: The pharmacokinetics and pharmacodynamics of dabigatran etexilate administered twice daily for three consecutive days (total 6 doses) at the end of standard anticoagulant therapy were assessed in an open-label safety and tolerability study in 9 stable adolescents (12 to < 18 years).
Slovenian: Farmakokinetiko in farmakodinamiko dabigatran eteksilata so pri dvakrat dnevnem dajanju tri zaporedne dni (skupno 6 odmerkov) ob koncu standardnega antikoagulacijskega zdravljenja ocenili v odprti študiji o varnosti in prenašanju pri 9 stabilnih mladostnikih (12 do < 18 let).
English: In patients at higher risk of bleeding or in major surgery where complete haemostasis may be required consider stopping Pradaxa 2-4 days before surgery.
Slovenian: Pri bolnikih s povečanim tveganjem krvavitve in pri velikih operacijah, pri katerih je lahko potrebna popolna hemostaza, je treba presoditi o ukinitvi zdravila Pradaxa 2 do 4 dni pred operacijo.
English: A non-interventional study (GLORIA-AF) prospectively collected (in its second phase) safety and effectiveness data in newly diagnosed NVAF patients on dabigatran etexilate in a real-world setting.
Slovenian: V neintervencijski študiji (GLORIA-AF) so bili (v drugi fazi študije) prospektivno zbrani podatki o varnosti in učinkovitosti pri na novo diagnosticiranih bolnikih z NVAF, ki so prejemali dabigatran eteksilat v realnem življenju.
English: In vitro interaction studies did not show any inhibition or induction of the principal isoenzymes of cytochrome P450.
Slovenian: Študije interakcij in vitro niso pokazale zaviranja ali indukcije glavnih izoencimov citokroma P450.
English: In addition, dabigatran AUCτ,ss and Cmax,ss and the coagulation measures for dabigatran effect or the inhibition of platelet aggregation as measure of clopidogrel effect remained essentially unchanged comparing combined treatment and the respective mono-treatments.
Slovenian: Poleg tega so bili dabigatranova AUCτ,ss in Cmax,ss ter merila za določanje učinka dabigatrana na strjevanje krvi ali zaviranje agregacije trombocitov kot merilo za učinek klopidogrela v glavnem nespremenjeni, ko so primerjali kombinirano zdravljenje in ustrezne monoterapije.
English: Active Cancer Patients (DVT/PE)
Slovenian: Bolniki z aktivnim rakom (GVT/PE)
English: This effect was seen primarily in patients ≥ 75 years.
Slovenian: Ta učinek so pretežno opazili pri 75-letnih bolnikih ali starejših.
English: As protein binding is low, dabigatran can be dialysed; there is limited clinical experience to demonstrate the utility of this approach in clinical studies (see section 5.2).
Slovenian: Zaradi majhne vezave na beljakovine, je dabigatran mogoče dializirati, vendar je le malo kliničnih izkušenj, ki bi kazale na tovrstno uporabnost v kliničnih študijah (glejte poglavje 5.2).
English: Caution should be exercised when interpreting these tests.
Slovenian: Izvide preskusov je treba razlagati previdno.
English: You may also need to talk to your doctor during treatment with Pradaxa if you experience symptoms or if you have to undergo surgery.
Slovenian: Med zdravljenjem z zdravilom Pradaxa se boste morali posvetovati z zdravnikom tudi, če se bodo pojavili simptomi ali ko boste potrebovali operativno zdravljenje.
English: • Hepatic impairment or liver disease expected to have any impact on survival
Slovenian: • jetrna okvara ali jetrna bolezen, ki bi predvidoma lahko vplivala na preživetje
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).
Slovenian: • če veste, da imate okvarjeno ledvično delovanje ali ste dehidrirani (imate simptome, kot so občutek žeje ali izločanje zmanjšane količine temnega (koncentriranega) seča);
English: 95 % confidence interval
Slovenian: 95-odstotni interval zaupanja
English: Age (years) 65 ≤ and < 75
Slovenian: Starost (leta) 65≤ in < 75
English: SSRIs, SNRIs SSRIs and SNRIs increased the risk of bleeding in all treatment groups of a phase III clinical trial comparing dabigatran to warfarin for stroke prevention in atrial fibrillation patients (RE-LY).
Slovenian: SSRI, SNRI SSRI in SNRI so povečali tveganje krvavitve pri vseh zdravljenih skupinah v III. fazi kliničnega preskušanja, v katerem so primerjali dabigatran z varfarinom glede preprečevanja možganske kapi pri bolnikih z atrijsko fibrilacijo (RE-LY).
English: Similar values for CrCL were found in RE-COVER II.
Slovenian: V študiji RE-COVER II so bile vrednosti CrCl podobne.
English: Component of a multipack, can´t be sold separately.
Slovenian: Enota v večkratnem pakiranju, prodaja posameznih enot ni možna.
English: ® is an oral anticoagulant (direct thrombin inhibitor).
Slovenian: ® je peroralni antikoagulant (neposredni zaviralec trombina).
English: However, limited clinical data with another P-gp substrate (everolimus) suggest that the inhibition of P-gp with tacrolimus is weaker than that observed with strong P-gp inhibitors.
Slovenian: Toda manjše število kliničnih podatkov za drugi substrat P-gp (everolimus) kaže, da je zaviralni učinek na P-gp pri takrolimusu šibkejši od opaženega pri močnih zaviralcih P-gp.
English: Of the 704 enrolled patients, 317 underwent atrial fibrillation ablation on uninterrupted dabigatran and 318 underwent atrial fibrillation ablation on uninterrupted warfarin.
Slovenian: Od 704 vključenih bolnikov je imelo 317 bolnikov ablacijo zaradi atrijske fibrilacije ob neprekinjenem jemanju dabigatrana, 318 bolnikov pa je imelo ablacijo zaradi atrijske fibrilacije ob neprekinjenem jemanju varfarina.
English: Food does not affect the bioavailability of dabigatran etexilate but delays the time to peak plasma concentrations by 2 hours.
Slovenian: Hrana ne vpliva na biološko uporabnost dabigatran eteksilata, toda za 2 uri podaljša čas do največje koncentracije v plazmi.
English: No dose adjustment is necessary (see section 5.2), but close clinical surveillance is recommended in patients with a body weight < 50 kg (see section 4.4).
Slovenian: Odmerka ni potrebno prilagajati (glejte poglavje 5.2), toda priporočamo natančno klinično spremljanje pri bolnikih s telesno maso < 50 kg (glejte poglavje 4.4).
English: • Recent biopsy, major trauma
Slovenian: • nedavna biopsija, večja poškodba
English: This resulted in a removal of 50 % to 60 % of dabigatran concentrations, respectively.
Slovenian: Dializa je odstranila 50 % do 60 % koncentracije dabigatrana.
English: SPECIAL STORAGE CONDITIONS Keep the bottle tightly closed.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Plastenko shranjujte tesno zaprto.
English: Four positional isomers, 1-O, 2-O, 3-O, 4-O-acylglucuronide exist, each accounts for less than 10 % of total dabigatran in plasma.
Slovenian: Poznamo štiri pozicijske izomere: 1-O-, 2-O-, 3-O- in 4-O-acilglukuronid, od katerih je delež vsakega manjši od 10 % skupnega dabigatrana v plazmi.
English: The half-life was independent of dose.
Slovenian: Razpolovna doba ni odvisna od velikosti odmerka.
English: Number of patients treated with Pradaxa
Slovenian: Število bolnikov zdravljenih z zdravilom Pradaxa
English: if you are suffering from an inflammation of the gullet or stomach.
Slovenian: • če imate vnetje požiralnika ali želodca,
English: gMean (gCV %; range) half-life [h]
Slovenian: gpovprečna (gCV%; razpon) razpolovna doba [h]
English: In this case Pradaxa will need to be stopped temporarily due to an increased bleeding risk during and shortly after an operation.
Slovenian: V tem primeru bo zdravilo Pradaxa treba začasno prekiniti zaradi povečane nevarnosti krvavitve med operacijo in krajši čas po njej.
English: There was no stroke/systemic embolism/TIA (composite) event in the dabigatran etexilate arm, and one event (TIA) in the warfarin arm from the time of ablation and until 8 weeks post-ablation.
Slovenian: V skupini z dabigatran eteksilatom se možganska kap/sistemska embolija/TIA (sestavljeni dogodek) ni pojavila, en dogodek (TIA) pa se je pojavil v skupini z varfarinom v času od ablacije in do 8 tednov po ablaciji.
English: The amount of substance cleared by dialysis is proportional to the blood flow rate up to a blood flow rate of 300 mL/min.
Slovenian: Količina snovi, ki se izloči med dializo, je sorazmerna hitrosti pretoka krvi vse do hitrosti pretoka krvi 300 ml/min.
English: In atrial fibrillation patients females had on average 30 % higher trough and post-dose concentrations.
Slovenian: Med bolniki z atrijsko fibrilacijo so imele ženske povprečno za 30 % večje koncentracije tik pred odmerkom in po odmerku.
English: Renal function (CrCL in mL/min)
Slovenian: Ledvično delovanje (CrCl v ml/min)
English: Pharmacotherapeutic group: antithrombotic agents, direct thrombin inhibitors, ATC code: B01AE07.
Slovenian: Farmakoterapevtska skupina: antitrombotiki, direktni zaviralci trombina, oznaka ATC: B01AE07
English: The anticoagulant activity of dabigatran decreased with decreasing plasma concentrations and the PK/PD relationship was not affected by the procedure.
Slovenian: Antikoagulacijsko delovanje dabigatrana se je manjšalo z manjšanjem njegovih koncentracij v plazmi, na farmakokinetično/farmakodinamično razmerje pa postopek ni vplival.
English: There are limited efficacy and safety data for Pradaxa available in these patients and therefore they should be treated with caution.
Slovenian: O učinkovitosti in varnosti zdravila Pradaxa pri teh bolnikih je malo podatkov, zato jih je treba zdraviti previdno.
English: With a loading dose of 300 mg or 600 mg clopidogrel, dabigatran AUCτ,ss and Cmax,ss were increased by about 30-40 % (see section 4.4) .
Slovenian: Pri polnilnem odmerku klopidogrela po 300 ali 600 mg sta se dabigatranovi AUCτ,ss in Cmax,ss povečali za približno 30 do 40 % (glejte poglavje 4.4).
English: For the primary safety endpoint of major bleeding there was an interaction of treatment effect and age.
Slovenian: Pri primarnem opazovanem dogodku, na podlagi katerega so ocenili varnost, in sicer pri veliki krvavitvi, so ugotovili interakcijo med učinkom zdravljenja in starostjo.
English: Elderly patients outside of the United States (≥80 years of age for all countries, ≥70 years of age for Japan) were randomly assigned to the dabigatran etexilate 110 mg dual-therapy group or the warfarin triple-therapy group.
Slovenian: Starejši bolniki zunaj Združenih držav Amerike (≥ 80 let za vse države, ≥ 70 let za Japonsko) so bili naključno razporejeni v skupino z dvojno terapijo z dabigatran eteksilatom 110 mg ali trojno terapijo z varfarinom.
English: Pradaxa treatment does not need to be interrupted (see section 5.1).
Slovenian: Zdravljenja z zdravilom Pradaxa ni potrebno prekinjati (glejte poglavje 5.1).
English: 10 days (knee replacement surgery) or 28-35 days (hip replacement surgery)
Slovenian: 10 dni (pri vstavitvi umetnega kolena) ali 28-35 dni (pri vstavitvi umetnega kolka)
English: While certain patient subgroups are at an increased risk of major bleeding when treated with an anticoagulant, the excess bleeding risk for dabigatran is due to GI bleeding, typically seen within the first 3-6 months following initiation of Pradaxa therapy.
Slovenian: Medtem ko se pri določenih podskupinah bolnikov med zdravljenjem z antikoagulantom poveča tveganje velikih krvavitev, k povečanju krvavitev pri uporabi dabigatrana prispevajo krvavitve v prebavilih, ki se značilno pojavljajo prve 3 do 6 mesecev po začetku zdravljenja z zdravilom Pradaxa.
English: Table 10: Number of patients studied, maximum daily dose in phase III studies Indication
Slovenian: Preglednica 10: Število preiskovanih bolnikov, maksimalni dnevni odmerek v študiji faze III