FrancophonIA/ELRC3.0 huggingface dataset:
English: In general, it can be assumed that these measures of anti-coagulant activity may reflect dabigatran levels and can provide guidance for the assessment of bleeding risk, i.e. exceeding the 90
Slovenian: Na splošno lahko predvidevamo, da opisana merila antikoagulacijskega delovanja kažejo raven dabigatrana in da jih je možno uporabiti kot vodilo pri ocenjevanju tveganja krvavitve.
English: LMWH The concomitant use of LMWHs, such as enoxaparin and dabigatran etexilate has not been specifically investigated.
Slovenian: LMWH Sočasne uporabe NMH, kot je enoksaparin in dabigatran eteksilata, niso posebej raziskovali.
English: This staggered intake is the recommended administration for start of ticagrelor with a loading dose.
Slovenian: Takšno jemanje z zamikom je priporočeni način uporabe pri uvajanju tikagrelorja s polnilnim odmerkom.
English: Treated patients
Slovenian: Zdravljeni bolniki
English: No double dose should be taken to make up for missed individual doses.
Slovenian: Bolnik ne sme vzeti dvojnega odmerka, da bi nadomestil izpuščeni odmerek.
English: 4 days before
Slovenian: 4 dni pred
English: The European Medicines Agency has waived the obligation to submit the results of studies with Pradaxa in all subsets of the paediatric population in prevention of thromboembolic events for the granted indication (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom Pradaxa pri preprečevanju trombemboličnih dogodkov pri odobreni indikaciji za vse podskupine pediatrične populacije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Diluted thrombin time (dTT), ecarin clotting time (ECT) and activated partial thromboplastin time (aPTT) may provide useful information, but results should be interpreted with caution due to inter-test variability (see section 5.1).
Slovenian: Koristne podatke je možno pridobiti z razredčitvenim preskusom za določanje trombinskega časa, (dTT - diluted thrombin time), ekarinskim časom koagulacije (EKT) in aktiviranim delnim tromboplastinskim časom (aPTČ), vendar je treba njihove rezultate razlagati previdno zaradi variabilnosti med testi (glejte poglavje 5.1).
English: Pradaxa treatment to Vitamin K antagonists (VKA):
Slovenian: Prehod z zdravila Pradaxa na antagoniste vitamina K:
English: If you take more Pradaxa than you should
Slovenian: Če ste vzeli večji odmerek zdravila Pradaxa, kot bi smeli
English: • Esophagitis, gastritis or gastroesophageal reflux
Slovenian: • ezofagitis, gastritis ali gastroezofagealni refluks
English: On subsequent days absorption of dabigatran is rapid with peak plasma concentrations attained 2 hours after medicinal product administration.
Slovenian: Naslednje dni se dabigatran hitro absorbira in doseže največje koncentracije v plazmi 2 uri po aplikaciji zdravila.
English: Tables 23-25 display results of the primary efficacy and safety endpoint in relevant sub-populations:
Slovenian: V preglednicah 23-25 so navedeni podatki o primarnem opazovanem dogodku, na podlagi katerega so ocenili učinkovitost in varnost zdravljenja v ustreznih podpulacijah:
English: The cleavage of the prodrug dabigatran etexilate by esterase-catalysed hydrolysis to the active principle dabigatran is the predominant metabolic reaction.
Slovenian: Cepitev predzdravila dabigatran eteksilata s hidrolizo, ki jo katalizira esteraza, v aktivno učinkovino dabigatran, je prevladujoča presnovna reakcija.
English: Dose adjustment should be decided at the discretion of the physician, following assessment of the potential benefit and risk to an individual patient (see table 1 above).
Slovenian: O prilagoditvi odmerka se odloči zdravnik na podlagi ocene med možno koristjo in tveganjem tega zdravljenja pri posameznem bolniku (glejte preglednico 1 zgoraj).
English: Indication SPAF and DVT/PE
Slovenian: Indikacija SPAF in GVT/PE
English: Pradaxa has no known effects on the ability to drive or use machines.
Slovenian: Zdravilo Pradaxa nima vpliva na sposobnost za vožnjo ali upravljanje strojev.
English: The calibrated quantitative diluted TT (dTT) test provides an estimation of dabigatran plasma concentration that can be compared to the expected dabigatran plasma concentrations.
Slovenian: Kalibrirani kvantitativni razredčitveni preskus za določanje trombinskega časa (dTT) daje oceno koncentracije dabigatrana v plazmi, ki jo lahko primerjamo s tovrstnimi pričakovanimi vrednostmi.
English: Date of birth
Slovenian: Ženske v rodni dobi
English: When the calibrated dTT assay delivers a dabigatran plasma concentration result at or below the limit of quantification, an additional coagulation assay such as TT, ECT or aPTT should be considered.
Slovenian: Če je koncentracija dabigatrana pri kalibriranem preskusu dTT na meji ali pod mejo merljivosti, je treba presoditi o uporabi dodatnega koagulacijskega preskusa, na primer TT, EKT ali aPTČ.
English: Importance of treatment compliance Necessity to carry the Patient alert card with them at all times The need to inform Health Care Professionals about all medicines they are currently taking The need to inform Health Care Professionals that they are taking Pradaxa if they need to have any surgery or invasive procedure.
Slovenian: znakih ali simptomih krvavitev ter o tem, kdaj poiskati zdravniško pomoč pomenu upoštevanja navodil o jemanju zdravila da morajo imeti opozorilno kartico za bolnika vedno pri sebi da morajo zdravstvene delavce obvestiti o vseh zdravilih, ki jih trenutno jemljejo da morajo zdravstvene delavcepred vsako operacijo ali invazivnim posegom opozoriti, da jemljejo zdravilo Pradaxa.
English: SPAF and DVT/PE
Slovenian: SPAF in GVT/PE
English: Pradaxa 220 mg N (%)
Slovenian: Zdravilo Pradaxa 220 mg N (%)
English: Use of platelet aggregation inhibitors such as clopidogrel and acetylsalicylic acid (ASA) or non steroidal antiinflammatory drugs (NSAID), as well as the presence of esophagitis, gastritis or gastroesophageal reflux increase the risk of GI bleeding.
Slovenian: Uporaba zaviralcev agregacije trombocitov, kot sta klopidogrel in acetilsalicilna kislina (ASK), ali nesteroidnih antirevmatikov (NSAR), kot tudi prisotnost ezofagitisa, gastritisa ali gastroezofagealnega refluksa, povečujejo tveganje za krvavitev v prebavilih.
English: Direct acting Oral Anticoagulants (DOACs) including dabigatran etexilate are not recommended for patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome.
Slovenian: Uporaba peroralnih antikoagulantov z neposrednim delovanjem, vključno z dabigatran eteksilatom, pri bolnikih z anamnezo tromboze in diagnozo antifosfolipidnega sindroma ni priporočljiva.
English: Speak to your doctor immediately if you experience any of the following possible signs and symptoms of bleeding: swelling, discomfort, unusual pain or headache, dizziness, paleness, weakness, unusual bruising, nosebleeds, bleeding of gums, unusual long bleeding cuts, abnormal menstrual flow or vaginal bleeding, blood in your urine which may be pink or brown, red/black stools, coughing up blood, vomiting blood or coffee ground like material.
Slovenian: Takoj se posvetujte z zdravnikom, če se pojavi kateri koli od naslednjih možnih znakov in simptomov krvavitev: oteklina, neprijeten občutek, nenavadna bolečina ali glavobol, omotica, bledica, oslabelost, nenavadno pojavljanje modric, krvavitve iz nosu, krvavenje dlesni, neobičajno dolgotrajno krvavenje iz ureznin, nenormalen menstrualni tok ali krvavenje iz vagine, kri v urinu, ki je lahko rožnata ali rjava, rdeče/črno blato, izkašljevanje krvi, bruhanje krvi ali materiala, ki izgleda kot mleta kava.
English: Stroke occurred in 0.65 per 100 patient-years.
Slovenian: Možganska kap se je pojavila pri 0,65 na 100 bolnikov-let.
English: For elderly patients > 75 years, a dose reduction is recommended (see table 1 above and sections 4.4 and 5.1).
Slovenian: Pri starejših bolnikih > 75 let je priporočeno zmanjšanje odmerka (glejte preglednico 1 zgoraj in poglavji 4.4 in 5.1).
English: The study included 4,859 patients on dabigatran etexilate (55% treated with 150 mg bid, 43% treated with 110 mg bid, 2% treated with 75 mg bid).
Slovenian: V študijo je bilo vključenih 4.859 bolnikov, ki so prejemali dabigatran eteksilat (55 % zdravljenih s 150 mg dvakrat na dan, 43 % zdravljenih s 110 mg dvakrat na dan in 2 % zdravljenih s 75 mg dvakrat na dan).
English: An unexplained fall in haemoglobin and/or haematocrit or blood pressure should lead to a search for a bleeding site.
Slovenian: Pri nepojasnjenem padcu hemoglobina in/ali hematokrita ali znižanju krvnega tlaka je potrebno iskati mesto krvavitve.
English: In this small number of adolescents, dabigatran etexilate capsules were apparently tolerated with only three mild and transient gastrointestinal adverse events reported by two patients.
Slovenian: Pri tej majhni skupini mladostnikov je kazalo, da kapsule dabigatran eteksilata prenašajo, saj sta samo dva poročala o treh blagih in prehodnih neželenih učinkih v prebavilih.
English: Pradaxa should be swallowed as a whole with a glass of water, to facilitate delivery to the stomach.
Slovenian: Zdravilo Pradaxa je treba pogoltniti celo s kozarcem vode, da se olajša prehod v želodec.
English: The starting time of the VKA should be adjusted based on CrCL as follows:
Slovenian: Začetek zdravljenja z antagonistom vitamina K je treba določiti na podlagi CrCl:
English: Caution should be exercised when treatment is temporarily discontinued for interventions and anticoagulant monitoring is warranted.
Slovenian: Če zdravljenje zaradi posega začasno prekinemo, sta potrebna previdnost in zagotovljeno spremljanje antikoagulacijskega učinka.
English: Interaction with P-gp inducers
Slovenian: Interakcija z induktorji P-gp
English: For patients randomized to warfarin, the mean percentage of time in therapeutic range (TTR) (INR 2-3) was 64.4 % (median TTR 67 %).
Slovenian: Pri bolnikih, ki so bili uvrščeni v zdravljenje z varfarinom, je bil povprečni delež časa, v katerem je bil INR v terapevtskem območju (TTR) (INR 2 do 3), 64,4 % (srednji TTR 67 %).
English: Once the bottle is opened, the medicinal product must be used within 4 months.
Slovenian: Po odprtju plastenke morate zdravilo porabiti v 4 mesecih.
English: Pradaxa should only be given if the benefit outweighs bleeding risks.
Slovenian: Zdravilo Pradaxa uvedemo le, če je korist večja od tveganj krvavitev.
English: In case of intolerability to Pradaxa, patients should be instructed to immediately consult their treating physician in order to be switched to alternate acceptable treatment options for prevention of stroke and systemic embolism associated with atrial fibrillation or for DVT/PE.
Slovenian: Bolnike je treba poučiti, da se morajo zaradi neprenašanja zdravila Pradaxa nemudoma posvetovati s svojim zdravnikom, ki jim bo zdravilo zamenjal s sprejemljivim alternativnim zdravljenjem za preprečevanje možganske kapi in sistemskih emboličnih dogodkov ob sočasni atrijski fibrilaciji ali pri GVT/PE.
English: RE-NOVATE (hip)
Slovenian: RE-NOVATE (kolk)
English: Dose adjustment should be decided at the discretion of the physician, following assessment of the potential benefit and risk to an individual patient (see table 2 above).
Slovenian: O prilagoditvi odmerka se odloči zdravnik na podlagi ocene med možno koristjo in tveganjem tega zdravljenja pri posameznem bolniku (glejte preglednico 2 zgoraj).
English: Patients were eligible for the RELY-ABLE trial if they had not permanently discontinued study medication at the time of their final RE-LY study visit.
Slovenian: Merila za vključitev v študijo RELY-ABLE so izpolnjevali bolniki, ki do zadnjega kontrolnega obiska v študiji RE-LY niso trajno prekinili zdravljenja s preizkušanim zdravilom.
English: Primary prevention of Venous Thromboembolism in Orthopaedic Surgery 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: Primarno preprečevanje venske trombembolije pri ortopedski operaciji Priporočeni odmerki zdravila Pradaxa in trajanje zdravljenja pri primarnem preprečevanju venske trombembolije pri ortopedski operaciji so prikazani v preglednici 1.
English: Close observation for signs of bleeding is recommended in patients concomitantly treated with NSAIDs (see section 4.5).
Slovenian: Za odkrivanje znakov krvavitve priporočamo pozorno spremljanje pri bolnikih, ki se sočasno zdravijo z zdravili NSAR (glejte poglavje 4.5).
English: Pantoprazole and other proton-pump inhibitors (PPI) were co-administered with Pradaxa in clinical trials, and concomitant PPI treatment did not appear to reduce the efficacy of Pradaxa.
Slovenian: Pantoprazol in druge zaviralce protonske črpalke so dajali sočasno z zdravilom Pradaxa v kliničnih preskušanjih, ki niso izkazala, da bi sočasno zdravljenje z zaviralci protonske črpalke zmanjšalo učinkovitost zdravila Pradaxa.
English: Particular caution should be exercised when Pradaxa is co-administered with verapamil, amiodarone, quinidine or clarithromycin (P-gp inhibitors) and particularly in the occurrence of bleeding, notably in patients having a mild to moderate renal impairment (see section 4.5).
Slovenian: Posebna previdnost je potrebna pri sočasni uporabi zdravila Pradaxa skupaj z verapamilom, amiodaronom, kinidinom ali klaritromicinom (zaviralci P-gp), predvsem ob pojavu krvavitve, še posebej pri bolnikih z blago do zmerno ledvično okvaro (glejte poglavje 4.5).
English: Table 8: Other interactions
Slovenian: Preglednica 8: Druga medsebojna delovanja
English: Furthermore, concomitant use of antiplatelets, ASA or clopidogrel approximately doubled major bleeding rates with both dabigatran etexilate and warfarin (see section 4.4).
Slovenian: Poleg tega se pri sočasni uporabi antitrombotikov, ASK ali klopidogrela približno podvoji število večjih krvavitev, tako pri dabigatran eteksilatu kot varfarinu (glejte poglavje 4.4).
English: - if you are currently bleeding.
Slovenian: • če ste pred kratkim krvaveli,
English: Pantoprazole When Pradaxa was co-administered with pantoprazole, a decrease in the dabigatran AUC of approximately 30 % was observed.
Slovenian: Pri sočasnem dajanju zdravila Pradaxa in pantoprazola se je vrednost AUC dabigatrana zmanjšala za približno 30 %.
English: Dialysis was conducted with 700 mL/min dialysate flow rate, four hour duration and a blood flow rate of either 200 mL/min or 350-390 mL/min.
Slovenian: Hitrost pretoka dializata je bila 700 ml/min, dializa je trajala štiri ure, hitrost pretoka krvi pa je bila 200 ml/min ali 350 do 390 ml/min.
English: An effect on female fertility was observed in the form of a decrease in implantations and an increase in pre-implantation loss at 70 mg/kg (5-fold the plasma exposure level in patients).
Slovenian: Učinek na plodnost samic se je pokazal v obliki manjšega števila implantacij in večje predimplantacijske izgube po odmerku 70 mg/kg (5-krat več, kot je pri bolnikih izpostavljenost zdravilu v plazmi).
English: • CrCL ≥ 50 mL/min, VKA should be started 3 days before discontinuing Pradaxa
Slovenian: • CrCl ≥ 50 ml/min, zdravljenje z antagonistom vitamina K je treba začeti 3 dni pred ukinitvijo zdravila Pradaxa;
English: The primary objective in this study was to determine if dabigatran etexilate was non-inferior to warfarin in reducing the occurrence of the composite endpoint stroke and systemic embolism.
Slovenian: Primarni cilj študije je bil ugotoviti, ali je dabigatran eteksilat enakovreden varfarinu pri zmanjšanju pojavnosti sestavljenega opazovanega dogodka, ki je zajemal možgansko kap in sistemske embolične dogodke.
English: Since the patient populations treated in the three indications are not comparable and bleeding events are distributed over several System Organ Classes (SOC), a summary description of major and any bleeding are broken down by indication and are provided in tables 11-14 below.
Slovenian: Ker populaciji bolnikov, ki prejemajo zdravljenje pri teh treh indikacijah, nista primerljivi in sodijo krvavitve v več skupin organskih sistemov, je povzetek velikih in vseh krvavitev razdeljen po indikacijah.
English: When taking Pradaxa capsules out of the blister pack, the following instructions should be followed:
Slovenian: Ko boste kapsule zdravila Pradaxa jemali iz pretisnega omota, upoštevajte naslednja navodila:
English: In patients treated for prevention of recurrent of DVT and PE with 150 mg dabigatran etexilate twice daily no pharmacokinetic data are available.
Slovenian: Za bolnike, ki so za preprečitev ponovitve GVT in PE jemali po 150 mg dabigatran eteksilata dvakrat na dan, ni na voljo podatkov o farmakokinetiki.
English: Capsule shell Carrageenan Potassium chloride Titanium dioxide Indigo carmine (E132) Hypromellose
Slovenian: Ovojnica kapsule karagenan kalijev klorid titanov dioksid indigotin (E132) hipromeloza
English: For the primary endpoint, stroke and systemic embolism, no subgroups (i.e., age, weight, gender, renal function, ethnicity, etc.) were identified with a different risk ratio compared to warfarin.
Slovenian: Glede primarnega opazovanega dogodka, in sicer možganske kapi in sistemskih emboličnih dogodkov, ni pri nobeni od podskupin (starost, telesna masa, spol, ledvično delovanje, etnična pripadnost itd) ugotovljeno drugačno razmerje tveganja v primerjavi z varfarinom.
English: The relative risk of bleeding with dabigatran compared to warfarin increased with age.
Slovenian: Relativno tveganje krvavitve se je med zdravljenjem z dabigatranom v primerjavi z varfarinom s starostjo povečalo.
English: • The hard capsules should not be pushed through the blister foil.
Slovenian: • Trdih kapsul ne smete potiskati skozi folijo na pretisnem omotu.
English: Dabigatran, the active moiety of dabigatran etexilate mesilate, is persistent in the environment.
Slovenian: Dabigatran, aktivni del dabigatrana eteksilata mesilata, je obstojen v okolju.
English: Instructions for opening the blisters
Slovenian: Navodilo za odpiranje pretisnega omota
English: This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
Slovenian: To lahko vključuje obstoječo ali nedavno razjedo v prebavilih, maligne novotvorbe, pri katerih je velika verjetnost krvavitve; nedavno poškodbo možganov ali hrbtenice, nedavno operacijo na možganih, hrbtenici ali očeh; nedavno intrakranialno krvavitev, znane varice požiralnika ali sum nanje, arteriovenske malformacije, žilne anevrizme ali večje intraspinalne ali intracerebralne žilne nepravilnosti;
English: If your kidney function is decreased by more than half or if you are 75 years of age or older, the recommended dose is 150 mg once a day (taken as 2 capsules of 75 mg).
Slovenian: Če je vaše ledvično delovanje zmanjšano za več kot polovico ali ste stari 75 let ali starejši, je za vas priporočeni odmerek 150 mg 1-krat na dan (2 kapsuli po 75 mg).
English: In animal studies an effect on female fertility was observed in the form of a decrease in implantations and an increase in pre-implantation loss at 70 mg/kg (representing a 5-fold higher plasma exposure level compared to patients).
Slovenian: V študijah na živalih se je učinek na plodnost samic pokazal v obliki manjšega števila implantacij in večje predimplantacijske izgube po odmerku 70 mg/kg (5-krat več, kot je pri bolnikih izpostavljenost zdravilu v plazmi).
English: Hazard ratio vs warfarin (95% confidence interval) non-inferiority margin Patients with event at 18 months Cumulative risk at
Slovenian: Razmerje ogroženosti v primerjavi z varfarinom (95-odstotni interval zaupanja) meja enakovrednosti Bolniki, ki so imeli dogodek v 18 mesecih
English: This exploratory study showed that dabigatran etexilate was associated with a significant reduction in MBE rate compared with INR-adjusted warfarin in the setting of ablation.
Slovenian: Ta raziskovalna študija je pokazala, da je bil ob opravljeni ablaciji dabigatran eteksilat povezan s signifikantno zmanjšano pojavnostjo velikih krvavitev v primerjavi z varfarinom, prilagojenim vrednostim INR.
English: In the pooled studies the primary safety endpoints of major bleeding, major or clinically relevant bleeding and any bleeding were significantly lower than warfarin at a nominal alpha level of 5 %.
Slovenian: Po združenih podatkih iz obeh študij so bili primarni opazovani dogodki velika krvavitev, velika ali klinično pomembna krvavitev in vse krvavitve značilno redkejši kot pri varfarinu, na 5-odstotni nominalni ravni alfa.
English: Take Pradaxa as your physician has told you.
Slovenian: ® jemljite, kot vam je naročil zdravnik.
English: Based on dabigatran concentrations as determined by the diluted thrombin time test and clinical assessment, the dose was adjusted to the target dose of 2.14 (± 10%) mg/kg bodyweight of dabigatran etexilate.
Slovenian: Na podlagi koncentracij dabigatrana, določenih z razredčitvenim preskusom za določanje trombinskega časa in klinične ocene so odmerek prilagodili ciljnemu odmerku dabigatran eteksilata 2,14 (± 10 %) mg/kg telesne mase.
English: • an aPTT ratio greater than 2-fold upper limit of normal (aPTT prolongation of about 80 seconds), at trough (10-16 hours after the previous dose) reflects the 90
Slovenian: • razmerje aPTČ, ki je večje od 2-kratne zgornje meje normalne vrednosti (podaljšanje aPTČ za približno 80 sekund), pri najmanjši vrednosti (10 do 16 ur po prejšnjem odmerku) izraža 90. percentil opažanj.
English: Concomitant use contraindicated (see section 4.3)
Slovenian: Sočasna uporaba je kontraindicirana (glejte poglavje 4.3) Ketokonazol
English: • NSAID
Slovenian: • NSAR
English: Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension.
Slovenian: Preprečevanje možganske kapi in sistemske embolije pri odraslih bolnikih z nevalvularno atrijsko fibrilacijo (NVAF) in enim ali več izmed dejavnikov tveganja, kot so prejšnja možganska kap ali prehodni ishemični napad (TIA), starost ≥ 75 let, srčno popuščanje (stopnja ≥ II po razvrstitvi Newyorške zveze za srce (NYHA)), sladkorna bolezen, hipertenzija.
English: A phase II study examined dabigatran etexilate and warfarin in a total of 252 patients with recent mechanical valve replacement surgery (i.e. within the current hospital stay) and in patients who received a mechanical heart valve replacement more than three months ago.
Slovenian: faze so dabigatran eteksilat in varfarin preverili pri skupno 252 bolnikih z nedavno operativno vstavitvijo umetne srčne zaklopke (med bivanjem v bolnišnici) in pri bolnikih, ki so jim umetno srčno zaklopko vstavili pred več kot tremi meseci.
English: In case of an overdose suspicion, coagulation tests can help to determine a bleeding risk (see sections 4.4 and 5.1).
Slovenian: Pri sumu na preveliko odmerjanje lahko s koagulacijskimi testi določimo tveganje krvavitve (glejte poglavji 4.4 in 5.1).
English: The clinical benefit of dabigatran with regard to stroke and systemic embolism prevention and decreased risk of ICH compared to warfarin is preserved across individual subgroups, e.g. renal impairment, age, concomitant medicinal product use such as anti-platelets or P-gp inhibitors.
Slovenian: Klinična korist zdravljenja z dabigatranom ostaja nespremenjena pri preprečitvi možganske kapi in sistemskih emboličnih dogodkov ter zmanjšanju tveganja intrakranialne krvavitve v primerjavi z varfarinom v posameznih podskupinah z boleznimi, kot so: ledvična okvara, starost, sočasna zdravila, na primer protitrombocitna zdravila ali zaviralci P-gp.
English: Patients should be instructed to contact the treating physician if they develop gastrointestinal symptoms such as dyspepsia (see section
Slovenian: Bolnikom je treba naročiti, naj se posvetujejo z lečečim zdravnikom, če se pri njih razvijejo simptomi v prebavilih, kot je dispepsija (glejte poglavje 4.8).