FrancophonIA/ELRC3.0 huggingface dataset:
English: In the RE-MODEL trial (knee replacement) treatment was for 6-10 days and in the RE-NOVATE trial (hip replacement) for 28-35 days.
Slovenian: V preskušanju RE-MODEL (vstavitev umetnega kolena) je zdravljenje trajalo 6 do 10 dni, v preskušanju RE-NOVATE (vstavitev umetnega kolka) pa 28 do 35 dni.
English: Specific pharmacokinetic phase I studies with elderly subjects showed an increase of 40 to 60 % in the AUC and of more than 25 % in Cmax compared to young subjects.
Slovenian: Specifične farmakokinetične študije faze I pri starejših osebah so pokazale 40- do 60-odstotno povečanje AUC in več kot 25-odstotno povečanje Cmax v primerjavi z mladimi osebami.
English: Table 9: Number of patients studied, maximum daily dose in phase III studies Indication
Slovenian: Preglednica 9: Število preiskovanih bolnikov, maksimalni dnevni odmerek v študiji faze III
English: Amiodarone When Pradaxa was co-administered with a single oral dose of 600 mg amiodarone, the extent and rate of absorption of amiodarone and its active metabolite DEA were essentially unchanged.
Slovenian: Amiodaron Pri sočasni uporabi zdravila Pradaxa in enkratnim peroralnim odmerkom amiodarona po 600 mg se obseg in hitrost absorpcije amiodarona in njegovega aktivnega presnovka DEA nista bistveno spremenila.
English: The primary endpoint was a combined endpoint of major bleeds based on ISTH definition or clinically relevant non-major bleeding event.
Slovenian: Primarni opazovani dogodek je bil sestavljeni opazovani dogodek velikih krvavitev po opredelitvi ISTH ali klinično pomembna ne-velika krvavitev.
English: Duration of dabigatran etexilate treatment ranged from 6 to 36 months (median 534.0 days).
Slovenian: Zdravljenje z dabigatran eteksilatom je trajalo 6 do 36 mesecev (srednje trajanje je bilo 534,0 dni).
English: In this situation Pradaxa and these medicinal products should be taken at the same time.
Slovenian: V tej situaciji je treba zdravilo Pradaxa in našteta zdravila jemati hkrati.
English: In the RE-SONATE study, which compared dabigatran etexilate to placebo, the rate of MI was 0.1% for patients who received dabigatran etexilate and 0.2% for patients who received placebo
Slovenian: V študiji RE-SONATE, v kateri so dabigatran eteksilat primerjali s placebom, je bila stopnja pojavnosti miokardnega infarkta 0,1 % pri bolnikih, ki so jemali dabigatran eteksilat, in 0,2 % pri tistih, ki so jemali placebo.
English: Dabigatran is a potent, competitive, reversible direct thrombin inhibitor and is the main active principle in plasma.
Slovenian: Dabigatran je močen, kompetitiven, reverzibilen direktni zaviralec trombina in glavna učinkovina v plazmi.
English: Pradaxa ® Information for Patients About your treatment
Slovenian: Informacije za bolnike O vašem zdravljenju
English: You can continue to take Pradaxa if your heart beat needs to be restored to normal by a procedure called cardioversion.
Slovenian: Zdravilo Pradaxa lahko jemljete še naprej, četudi je bilo vaš srčni utrip potrebno normalizirati s postopkom, ki se mu reče kardioverzija.
English: Patients with elevated liver enzymes > 2 ULN were excluded in controlled clinical trials investigating the VTE prevention following elective hip or knee replacement surgery.
Slovenian: Bolnike s povečanimi jetrnimi encimi na > 2 ULN so izključili iz nadzorovanih kliničnih preskušanj, v katerih so proučevali preprečevanje VTE po operativni vstavitvi umetnega kolka ali kolena.
English: The RE-LY extension study (RELY-ABLE) provided additional safety information for a cohort of patients which continued the same dose of dabigatran etexilate as assigned in the RE-LY trial.
Slovenian: V podaljšku študije RE-LY (RELY-ABLE) so pridobili dodatne podatke o varnosti v kohorti bolnikov, ki so nadaljevali z jemanjem enakega odmerka dabigatran eteksilata, kot je bil predpisan v študiji RE-LY.
English: An increased risk was seen in the elderly (≥ 75 years) for the 150 mg twice daily dose regimen.
Slovenian: Povečano tveganje so opazili pri starejših (≥ 75 let) pri odmerjanju 150 mg dvakrat na dan.
English: Patients who underwent Percutaneous coronary intervention (PCI) with stenting
Slovenian: Bolniki, ki so imeli perkutano koronarno intervencijo (PKI) z vstavitvijo žilne opornice
English: Results of both studies showed that the antithrombotic effect of Pradaxa 220 mg and 150 mg were statistically non-inferior to that of enoxaparin on total VTE and all-cause mortality.
Slovenian: Izsledki obeh študij so pokazali, da antitrombotični učinek zdravila Pradaxa v odmerku 220 mg in 150 mg ni statistično manjši od učinka enoksaparina, če upoštevamo skupno pojavnost trombemboličnih dogodkov in umrljivost iz vseh vzrokov.
English: Haemorrhagic complications may present as weakness, paleness, dizziness, headache or unexplained swelling, dyspnoea, and unexplained shock.
Slovenian: Zapleti s krvavitvami se lahko pokažejo kot oslabelost, bledica, omotica, glavobol ali nepojasnjeno otekanje, dispneja in nepojasnjen šok.
English: Life-threatening bleeding was reported in 0.46 per 100 patient-years, intracranial haemorrhage in 0.17 per 100 patient-years and gastrointestinal bleeding in 0.60 per 100 patient-years.
Slovenian: O življenjsko nevarnih krvavitvah so poročali pri 0,46 na 100 bolnik-let, o intrakranialni krvavitvi pri 0,17 na 100 bolnikov-let in o krvavitvi v prebavilih pri 0,60 na 100 bolnik-let.
English: When taking a hard capsule out of the bottle, the following instructions should be observed:
Slovenian: Ko boste jemali trde kapsule iz plastenke, morate upoštevati naslednja navodila:
English: Dosing should be reduced as indicated in table 1 (see also sections 4.4 and 4.5).
Slovenian: Odmerek je treba zmanjšati, kot je navedeno v preglednici 1 (glejte tudi poglavji 4.4 in 4.5).
English: In a study performed with 24 healthy subjects, when Pradaxa was co-administered with digoxin, no changes on digoxin and no clinically relevant changes on dabigatran exposure have been observed.
Slovenian: V študiji na 24 zdravih osebah, kjer so zdravilo Pradaxa dajali sočasno z digoksinom, niso zasledili spremenjene izpostavljenosti digoksinu ali klinično pomembno spremenjene izpostavljenosti dabigatranu.
English: Substances influencing gastric pH
Slovenian: Snovi, ki vplivajo na želodčni pH
English: if you have problems with reflux of gastric juice into the gullet.
Slovenian: • če imate težave z zatekanjem želodčnega soka v požiralnik,
English: Pre-dosing of the probe inducer rifampicin at a dose of 600 mg once daily for 7 days decreased total dabigatran peak and total exposure by 65.5 % and 67 %, respectively.
Slovenian: Pri predhodnem dajanju preizkušanega induktorja rifampicina v odmerkih po 600 mg enkrat na dan, 7 dni, sta se skupna najvišja koncentracija dabigatrana in izpostavljenost zmanjšala za 65,5 oziroma 67 %.
English: Active substance exposure in the primary VTE prevention studies was about 40 % to 50 % higher in female patients and no dose adjustment is recommended.
Slovenian: Izpostavljenost zdravilni učinkovini v študijah o preprečevanju VTE je bila približno 40 do 50 % večja pri bolnicah, prilagajanja odmerka pa ne priporočajo.
English: Hepatic impairment or liver disease expected to have any impact on survival is contraindicated (see section 4.3).
Slovenian: Jetrna okvara ali jetrna bolezen, ki bi lahko vplivala na preživetje, je kontraindicirana (glejte poglavje 4.3).
English: No clinically relevant inter-ethnic differences among Caucasian, African-American, Hispanic, Japanese or Chinese patients were observed regarding dabigatran pharmacokinetics and pharmacodynamics.
Slovenian: Pri belcih, Afroameričanih, hispanih, Japoncih in Kitajcih niso ugotovili medetničnih razlik v dabigatranovi farmakokinetiki in farmakodinamiki.
English: if you are suffering from an infection of the heart (bacterial endocarditis).
Slovenian: • če imate bakterijski endokarditis (okužbo notranje srčne ovojnice),
English: Test (trough value) dTT [ng/mL]
Slovenian: Preskus (najnižja vrednost) dTT [ng/ml]
English: The efficacy and safety have not been established for DVT/PE patients with active cancer.
Slovenian: Učinkovitost in varnost zdravila pri bolnikih z GVT ali PE in aktivnim rakom še nista raziskani.
English: Patients at high surgical mortality risk and with intrinsic risk factors for thromboembolic events
Slovenian: Bolniki z velikim tveganjem umrljivosti med operacijo in intrinzičnimi dejavniki tveganja za trombembolične dogodke
English: Both dose strengths of Pradaxa had also a statistically significant lower total bleed rate.
Slovenian: Pri obeh jakostih zdravila Pradaxa je bil statistično značilno manjši tudi odstotek vseh krvavitev.
English: ® may need to be stopped in advance of surgical or other invasive procedures.
Slovenian: ® bo morda treba ukiniti pred operacijami in drugimi invazivnimi postopki.
English: • Renal function should be assessed by calculating the creatinine clearance (CrCL) prior to initiation of treatment with Pradaxa to exclude patients with severe renal impairment (i.e. CrCL < 30 mL/min) (see sections 4.3, 4.4 and 5.2).
Slovenian: • Ledvično delovanje je treba na podlagi izračuna kreatininskega očistka (CrCl) oceniti pred začetkom zdravljenja z zdravilom Pradaxa, da bi lahko izključili bolnike s hudo ledvično okvaro (tj. CrCl < 30 ml/min) (glejte poglavja 4.3, 4.4 in 5.2).
English: Blister and bottle 3 years
Slovenian: Pretisni omot in plastenka 3 leta
English: RELY-ABLE (Long term multi-center extension of dabigatran treatment in patients with atrial fibrillation who completed the RE-LY trial)
Slovenian: Študija RELY-ABLE (dolgotrajen, multicentrični podaljšek zdravljenja z dabigatranom pri bolnikih z atrijsko fibrilacijo po končani študiji RE-LY)
English: Pharmacodynamic and kinetic factors
Slovenian: Farmakodinamični in kinetični dejavniki
English: Since dabigatran is excreted predominantly by the renal route adequate diuresis must be maintained.
Slovenian: Ker se dabigatran pretežno izloča preko ledvic, moramo vzdrževati ustrezno diurezo.
English: As this patient alert card contains important information about your treatment, please carry this card with you at all times to inform healthcare professionals about your intake of Pradaxa
Slovenian: Opozorilna kartica za bolnika vsebuje pomembne podatke o vašem zdravljenju, zato jo imejte vedno pri sebi, tako boste lahko zdravstvenim delavcem pokazali, da jemljete zdravilo Pradaxa
English: • Details of populations potentially at higher risk of bleeding
Slovenian: • Podroben opis populacij, pri katerih je lahko povečano tveganje krvavitev
English: All patients received an initial oral dose of 1.71 (± 10%) mg/kg of dabigatran etexilate (80 % of the adult dose of 150 mg/70 kg adjusted for the patient's weight).
Slovenian: Vsi bolniki so dobili začetni peroralni odmerek po 1,71 (± 10 %) mg/kg dabigatran eteksilata (80 % odmerka za odrasle 150 mg/70 kg, prilagojeno bolnikovi telesni masi).
English: None of these diseases showed an impact on the effects of dabigatran on VTE-prevention or bleeding rates.
Slovenian: Nobena od naštetih bolezni ni vplivala na učinkovitost dabigatrana pri preprečevanju venskih trombemboličnih dogodkov ali stopnjo krvavitve.
English: The median CrCL in the RE-COVER study was 100.4 mL/min.
Slovenian: Mediana CrCl je bila v študiji RE-COVER 100,4 ml/min.
English: • In case of major bleeding events, Pradaxa ® must be stopped immediately.
Slovenian: • Pri večjih krvavitvah je treba zdravilo Pradaxa ® nemudoma ukiniti.
English: Clearance of dabigatran in patients with renal insufficiency may take longer (see section 5.2).
Slovenian: Pri bolnikih z ledvično insuficienco se lahko podaljša dabigatranov očistek (glejte poglavje 5.2).
English: Clearance of dabigatran by haemodialysis was investigated in 7 patients with end-stage renal disease (ESRD) without atrial fibrillation.
Slovenian: Očistek dabigatrana med hemodializo so proučevali pri 7 bolnikih s končnim stadijem ledvične bolezni in brez atrijske fibrilacije.
English: Prevention of blood clot formation after knee or hip replacement surgery Continue with your remaining daily doses of Pradaxa at the same time of the next day.
Slovenian: Preprečevanje nastajanja krvnih strdkov po operativni vstavitvi umetnega kolena ali kolka Nadaljujte s preostalim dnevnim odmerkom zdravila Pradaxa ob istem času naslednjega dne.
English: Metabolism and excretion of dabigatran were studied following a single intravenous dose of radiolabeled dabigatran in healthy male subjects.
Slovenian: Presnavljanje in izločanje dabigatrana so raziskovali po enkratnem intravenskem odmerku radioaktivno označenega dabigatrana pri zdravih moških.
English: • Do not push the capsules through the blister foil.
Slovenian: • Kapsul ne potiskajte skozi pretisno folijo.
English: -if you fall or injure yourself during treatment, especially if you hit your head.Please seek urgent medical attention.
Slovenian: -če med zdravljenjem padete ali se poškodujete, zlasti če se udarite v glavo.Poiščite nujno medicinsko pomoč.
English: Concomitant administration of P-gp inducers is expected to result in decreased dabigatran plasma concentrations, and should be avoided (see sections 4.5 and 5.2).
Slovenian: Pri sočasnem dajanju induktorjev P-gp je pričakovano zmanjšanje koncentracije dabigatrana v plazmi in se jih je treba izogibati (glejte poglavji 4.5 in 5.2)
English: The European Medicines Agency has waived the obligation to submit the results of studies with Pradaxa in all subsets of the paediatric population for the granted indications (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odložila obveznost predložitve rezultatov študij z zdravilom Pradaxa za vse skupine pediatrične populacije za odobreno indikacijo (za podatek o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Other patients at increased risk of bleeding
Slovenian: Drugi bolniki s povečanim tveganjem krvavitve
English: For DVT/PE the recommendation for the use of Pradaxa 220 mg taken as one 110 mg capsule twice daily is based on pharmacokinetic and pharmacodynamic analyses and has not been studied in this clinical setting.
Slovenian: Priporočilo o uporabi zdravila Pradaxa v odmerku po 220 mg pri GVT/PE, ki ga bolnik vzame kot eno kapsulo po 110 mg dvakrat na dan, temelji na farmakokinetičnih in farmakodinamičnih analizah in v takšnih kliničnih razmerah še ni raziskano.
English: Patients with gastritis, esophagitis or gastroesophageal reflux
Slovenian: Bolniki z gastritisom, ezofagitisom ali gastroezofagealnim refluksom
English: DVT/PE The duration of therapy should be individualised after careful assessment of the treatment benefit against the risk for bleeding (see section 4.4).
Slovenian: GVT/PE Trajanje zdravljenja je treba po skrbni presoji med koristijo zdravljenja in tveganjem krvavitve individualno prilagoditi (glejte poglavje 4.4).
English: All bleeding events which occurred during warfarin therapy are included except for those during the overlap period between warfarin and parenteral therapy.
Slovenian: Zajete so tudi vse krvavitve, ki so je pojavile med zdravljenjem z varfarinom, razen reakcij v obdobju prekrivanja zdravljenja z varfarinom in parenteralnega zdravljenja.
English: - Medicines to reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin,
Slovenian: - zdravila za zmanjšanje nastajanja krvnih strdkov (npr. varfarin, fenprokoumon, acenokumarol,
English: A study evaluating post-operative absorption of dabigatran etexilate, 1-3 hours following surgery, demonstrated relatively slow absorption compared with that in healthy volunteers, showing a smooth plasma concentration-time profile without high peak plasma concentrations.
Slovenian: Študija, v kateri so ocenjevali pooperativno absorpcijo dabigatran eteksilata, je 1 do 3 ure po operaciji pokazala razmeroma počasno absorpcijo v primerjavi s podatki za zdrave prostovoljce; profil koncentracije v plazmi v odvisnosti od časa pa je bil enakomeren in brez vrhov koncentracij v plazmi.
English: If you are taking verapamil containing medicines and your kidney function is decreased by more than half, you should be treated with a reduced dose of 75 mg Pradaxa because your bleeding risk may be increased.
Slovenian: Če jemljete zdravilo, ki vsebuje verapamil, in je delovanje vaših ledvic za več kot polovico zmanjšano, morate jemati zmanjšan odmerek zdravila Pradaxa po 75 mg, ker je pri vas tveganje za krvavitve povečano.
English: Pradaxa should be stopped before elective surgery High risk of bleeding or major surgery
Slovenian: Zdravilo Pradaxa je potrebno ukiniti pred elektivnim kirurškim posegom Veliko tveganje krvavitve ali večja operacija
English: No clinically relevant ethnic differences among Caucasians, African-American, Hispanic, Japanese or Chinese patients were observed.
Slovenian: Med belci, Afroameričani, hispani, Japonci in Kitajci ni bilo klinično pomembnih razlik.
English: You can continue to take Pradaxa if your heart beat needs to be restored to normal by a procedure called cardioversion or by a procedure called catheter ablation for atrial fibrillation.
Slovenian: Zdravilo Pradaxa lahko jemljete še naprej, četudi je bilo vaš srčni utrip potrebno normalizirati s postopkom, ki se mu reče kardiokonverzija ali s postopkom, ki se mu reče katetrska ablacija zaradi atrijske fibrilacije.
English: The effect by age on exposure to dabigatran was confirmed in the RE-LY study with an about 31 % higher trough concentration for subjects ≥ 75 years and by about 22 % lower trough level for subjects < 65 years compared to subjects between 65 and 75 years (see sections 4.2 and 4.4).
Slovenian: Vpliv starosti na izpostavljenost dabigatranu so potrdili v študiji RE-LY, v kateri so bile najmanjše koncentracije pri 75 let starih preizkušancih in starejših za 31 % večje, pri mlajših od 65 let pa za 22 % manjše kot pri tistih med 65. in 75. letom (glejte poglavji 4.2 in 4.4).
English: The clinical studies have been conducted in a patient population with a mean age > 65 years.
Slovenian: Srednja starost populacije bolnikov v študijah je bila > 65 let.
English: The risk of bleedings may be increased in certain patient groups e.g. those patients with moderate renal impairment and/or on concomitant treatment affecting haemostasis or strong P-gp inhibitors (see section 4.4 Haemorrhagic risk).
Slovenian: Tveganje za krvavitve se lahko poveča pri določenih skupinah bolnikov, npr. pri bolnikih z zmerno ledvično okvaro in/ali pri sočasnem zdravljenju, ki vpliva na hemostazo, ali sočasnem zdravljenju z močnimi zaviralci P-gp (glejte poglavje 4.4 Tveganje za krvavitve).
English: if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen,piroxicam.
Slovenian: • če jemljete protivnetna zdravila, kot so diklofenak, ibuprofen, piroksikam;
English: Pradaxa affects blood clotting, so most side effects are related to signs such as bruising or bleeding.
Slovenian: Zdravilo Pradaxa učinkuje na strjevanje krvi, zato se pri večini neželenih učinkov pojavljajo znaki, kot so modrice ali krvavitve.
English: Pradaxa treatment can be re-initiated 24 hours after administration of Praxbind (idarucizumab), if the patient is clinically stable and adequate haemostasis has been achieved.
Slovenian: Zdravilo Pradaxa lahko bolnik ponovno prejme 24 ur po dajanju zdravila Praxbind (idarucizumab), če je njegovo klinično stanje stabilno in je zagotovljena ustrezna hemostaza.
English: No other effects on female fertility were observed.
Slovenian: Drugih učinkov na plodnost samic niso ugotovili.
English: -if you have a liver disease that is associated with changes in the blood tests.The use of Pradaxa is not recommended in this case.
Slovenian: - če imate jetrno bolezen, ki je povezana s spremenjenimi izvidi krvnih preiskav, uporabe zdravila Pradaxa ne priporočamo.
English: Pradaxa dabigatran etexilate
Slovenian: Pradaxa dabigatran eteksilat
English: Continue with your remaining daily doses of Pradaxa at the same time of the next day.
Slovenian: Nadaljujte s preostalim dnevnim odmerkom zdravila Pradaxa ob istem času naslednjega dne.
English: Tacrolimus has been found in vitro to have a similar level of inhibitory effect on Pgp as that seen with itraconazole and cyclosporine.
Slovenian: Ugotovljeno je bilo, da je imel takrolimus in vitro podoben zaviralni učinek na P-gp kot je bil opažen pri itrakonazolu in ciklosporinu.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Swallow whole, do not chew or break the capsule.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Kapsule pogoltnite cele, ne žvečite in ne lomite.
English: No difference was found for major bleeding (hazard ratio 0.97, CI 0.88 - 1.07).
Slovenian: Glede večjih krvavitev niso opazili razlik (razmerje tveganja 0,97, IZ 0,88
English: The MAH shall also provide a patient alert card in each medication pack, the text of which is included in Annex III.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora vvsakempakiranjuzagotoviti opozorilnokartico za bolnika, katerebesedilo se nahaja v prilogi III.
English: Peel off the backing foil and remove the capsule.
Slovenian: Odlepite zaščitno folijo in vzemite ven kapsulo.
English: A calibrated quantitative dTT test or repetitive dTT measurements allow prediction of the time by when certain dabigatran levels will be reached (see section 5.1), also in case additional measures e.g. dialysis have been initiated.
Slovenian: S kalibriranim kvantitativnim testom dTT ali ponovljenimi meritvami dTT lahko napovemo čas, v katerem bo dosežena določena raven dabigatrana (glejte poglavje 5.1), tudi po uvajanju dodatnih ukrepov, na primer dialize.
English: ® thins the blood, which prevents you from getting dangerous bood clots.
Slovenian: ® redči kri, kar preprečuje nastajanje nevarnih krvnih strdkov.
English: Dose reductions may be required in combination with some P-gp inhibitors (see sections 4.2, 4.3, 4.4 and 5.1).
Slovenian: V kombinaciji z nekaterimi zaviralci P-gp so lahko potrebna zmanjšanja odmerkov (glejte poglavja 4.2, 4.3, 4.4 in 5.1).
English: There is limited amount of data from the use of Pradaxa in pregnant women.
Slovenian: Podatki o uporabi zdravila Pradaxa pri nosečnicah so omejeni.
English: A dose reduction should be either considered or is recommended as indicated in section 4.2.
Slovenian: Vredno je razmisliti o zmanjšanju odmerka oziroma je zmanjšanje odmerka priporočeno, kot je navedeno v poglavju 4.2.
English: Dabigatran AUCτ,ss and Cmax,ss were increased on average by 1.53-fold and 1.56-fold, respectively with concomitant quinidine (see sections 4.2 and 4.4).
Slovenian: Dabigatranovi AUCτ,ss in Cmax,ss sta se med sočasnim dajanjem kinidina povprečno povečali za 1,53-krat oziroma 1,56-krat (glejte poglavji 4.2 in 4.4).
English: The method to be used to estimate renal function (CrCL in mL/min) is the Cockcroft-Gault method.
Slovenian: Ledvično delovanje (CrCl v ml/min) je treba oceniti po Cockcroft-Gaultovi metodi.
English: If treatment is not started on the day of surgery then treatment should be initiated with 2 capsules once daily.
Slovenian: Če zdravljenja ne uvedemo na dan operacije, ga moramo začeti z 2 kapsulama 1-krat na dan.
English: No change in dabigatran exposure was seen in 12 subjects with moderate hepatic insufficiency (Child Pugh B) compared to 12 controls (see sections 4.2 and 4.4).
Slovenian: Pri 12 osebah z zmerno jetrno insuficienco (Child-Pugh B) niso zasledili spremembe pri izpostavljenosti dabigatranu v primerjavi z 12 kontrolnimi osebami (glejte poglavji 4.2 in 4.4).
English: Cautions to be exercised in case concomitant use (see sections 4.2 and 4.4)
Slovenian: V primeru sočasne uporabe je potrebna previdnost (glejte poglavji 4.2 in 4.4)
English: Pradaxa treatment should not be discontinued without medical advice.
Slovenian: Zdravila Pradaxa se ne sme prenehati jemati brez posveta z zdravnikom.
English: It is recommended to continue with the remaining daily doses of Pradaxa at the same time of the next day.
Slovenian: Priporočeno je nadaljevati z jemanjem preostalih dnevnih odmerkov zdravila Pradaxa naslednji dan ob isti uri.
English: Pradaxa can be taken with or without food.
Slovenian: • Zdravilo Pradaxa lahko jemljete s hrano ali brez.