FrancophonIA/ELRC3.0 huggingface dataset:
English: The effect was progressively decreased with administration of an extended release formulation (increase of Cmax by about 1.9-fold and AUC by about 1.7-fold) or administration of multiple doses of verapamil (increase of Cmax by about 1.6-fold and AUC by about 1.5-fold).
Slovenian: Ta učinek se je progresivno manjšal, če so uporabili obliko s podaljšanim sproščanjem (povečanje Cmax za približno 1,9-krat in AUC za približno 1,7-krat) ali več odmerkov verapamila (povečanje Cmax za približno 1,6-krat in AUC za približno 1,5-krat).
English: Paediatric population (DVT/PE)
Slovenian: Pediatrična populacija (GVT/PE)
English: Pradaxa contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants.
Slovenian: Pradaxa vsebuje učinkovino dabigatran eteksilat in spada v skupino zdravil, ki se imenujejo antikoagulanti.
English: The rates of outcome events including, major bleed and other bleeding events were consistent with those seen in RE-LY.
Slovenian: Stopnje opazovanih dogodkov, ki so zajemali velike in druge krvavitve, se niso razlikovale od njihovih ugotovljenih v študiji RE-LY.
English: For dose modifications in this population see table 1 above.
Slovenian: Za spremembe odmerkov pri tej skupini bolnikov glejte preglednico 1 zgoraj.
English: From the data collected in the phase III study RE-LY (see section 5.1) it was observed that the concomitant use of other oral or parenteral anticoagulants increases major bleeding rates with both dabigatran etexilate and warfarin by approximately 2.5-fold, mainly related to situations when switching from one anticoagulant to another (see section 4.3).
Slovenian: Podatki iz III. faze študije RE-LY (glejte poglavje 5.1) kažejo, da se pri sočasni uporabi drugih peroralnih in parenteralnih antikoagulantov za približno 2,5-krat poveča število večjih krvavitev, tako pri dabigatran eteksilatu kot varfarinu, predvsem pri zamenjavi enega antikoagulanta z drugim (glejte poglavje 4.3).
English: RE-MEDY, warfarin controlled study, enrolled patients already treated for 3 to 12 months with the need for further anticoagulant treatment and RE-SONATE, the placebo controlled study, enrolled patients already treated for 6 to 18 months with Vitamin K inhibitors.
Slovenian: V študiji RE-MEDY, v kateri so za kontrolno zdravilo uporabili varfarin, so sprejeli bolnike, ki so se zdravili že 3 do 12 mesecev in so potrebovali nadaljnje antikoagulacijsko zdravljenje, v študijo RE-SONATE, v kateri je kontrolna skupina jemala placebo, pa so sprejeli bolnike, ki so se prej že 6 do 8 mesecev zdravili z zaviralci vitamina K.
English: Concomitant administration is expected to result in decreased dabigatran concentrations.
Slovenian: Sočasna uporaba predvidoma zmanjša dabigatranovo koncentracijo.
English: In the clinical study 1160.88 in total, 9 adolescent patients (age 12 to < 18 years) with diagnosis of primary VTE received an initial oral dose of dabigatran etexilate of 1.71 (± 10 %) mg/kg bodyweight.
Slovenian: V klinični študiji 1160.88 je skupno 9 mladostnikov (starih 12 do < 18 let) z diagnozo primarne VTE prejelo začetni peroralni odmerek dabigatran eteksilata po 1,71 (± 10 %) mg/kg telesne mase.
English: Patients who develop acute renal failure must discontinue Pradaxa (see also section 4.3).
Slovenian: Bolniki, pri katerih se razvije akutna ledvična odpoved, morajo zdravilo Pradaxa prenehati jemati (glejte tudi poglavje 4.3).
English: Patients included in safety analysis Major bleeding events Intracranial Bleeding Major GI bleeding Life-threatening bleed Major bleeding events/clinically relevant bleeds Any bleeding Any GI bleeding
Slovenian: Bolniki, vključeni v analizo o varnosti Velike krvavitve intrakranialna krvavitev velika krvavitev v prebavilih življenjsko nevarna krvavitev Velike krvavitve/klinično pomembne krvavitve Vse krvavitve vse krvavitve v prebavilih
English: • Inform your doctor about your intake of Pradaxa
Slovenian: • Obvestite svojega zdravnika o jemanju zdravila Pradaxa
English: On treatment 2 (22.1 %) patients experienced mild related adverse events (gastrooesophageal reflux / abdominal pain; abdominal discomfort) and 1 (11.1 %) patient experienced a not related serious adverse event (recurrent VTE of the leg) in the post treatment period > 3 days after stop of dabigatran etexilate.
Slovenian: Dva bolnika (22,1 %) sta imela blage, z zdravljenjem povezane neželene dogodke (gastroezofagealni refluks/trebušna bolečina; abdominalno nelagodje), en (11,1 %) pa z zdravljenjem nepovezani resen neželeni dogodek (ponovitev VTE v nogi) v obdobju po zdravljenju, več kot 3 dni po ukinitvi dabigatran eteksilata.
English: Pradaxa 150 mg N (%)
Slovenian: Zdravilo Pradaxa 150 mg N (%)
English: Other medicines and Pradaxa
Slovenian: Druga zdravila in zdravilo Pradaxa
English: With improving monitoring of INR the observed benefits of dabigatran etexilate compared to warfarin diminish.
Slovenian: Z izboljšanim spremljanjem INR se koristi dabigatran eteksilata v primerjavi z varfarinom zmanjšajo.
English: RE-SONATE demonstrated dabigatran etexilate was superior to placebo for the prevention of recurrent symptomatic DVT/PE events including unexplained deaths, with a risk reduction from 5.6 % to 0.4 % (relative risk reduction 92 % based on hazard ratio ) during the treatment period (p<0.0001).
Slovenian: Izsledki študije RE-SONATE so pokazali, da je dabigatran eteksilat v primerjavi s placebom superiorno zdravilo za preprečevanje ponovitev simptomatične GVT ali PE, vključno z nepojasnjenimi smrtmi, z zmanjšanjem tveganja iz 5,6 % na 0,4 % (relativno zmanjšanje tveganja 92 % na podlagi razmerja ogroženosti) v obdobju zdravljenja (p < 0,0001).
English: • After removing the capsule, place the cap back on the bottle and tightly close the bottle right away after you take your dose.
Slovenian: • Ko ste kapsulo vzeli ven, namestite na plastenko pokrovček in jo takoj po jemanju odmerka tesno zaprite.
English: Pradaxa should be used with caution in conditions with an increased risk of bleeding or with concomitant use of medicinal products affecting haemostasis by inhibition of platelet aggregation.
Slovenian: Zdravilo Pradaxa je treba previdno uporabljati pri stanjih s povečanim tveganjem krvavitve ali sočasni uporabi zdravil, ki vplivajo na hemostazo z zaviranjem agregacije trombocitov.
English: After switching from 3-day treatment of once daily 40 mg enoxaparin s.c., 24 hours after the last dose of enoxaparin the exposure to dabigatran was slightly lower than that after administration of dabigatran etexilate (single dose of 220 mg) alone.
Slovenian: Po prehodu s 3-dnevnega zdravljenja z enim odmerkom enoksaparina po 40 mg sc. na dan, je bila 24 ur po zadnjem odmerku enoksaparina izpostavljenost dabigatranu nekoliko manjša kot po dajanju samega dabigatran eteksilata (enkratnega odmerka po 220 mg).
English: Two randomized, parallel group, double-blind studies were performed in patients previously treated with anticoagulation therapy.
Slovenian: Opravljeni sta bili dve dvojno slepi študiji s paralelnimi skupinami naključno izbranih bolnikov, ki so predhodno že jemali antikoagulacijska zdravila.
English: Table 8: Adverse reactions SOC / Preferred term
Slovenian: Preglednica 8: Neželeni učinki Organski sistem / prednostno poimenovanje
English: The safety of Pradaxa has been evaluated in a pivotal study investigating the prevention of stroke and systemic embolism in patients with atrial fibrillation, in two active controlled DVT/PE treatment trials and in one active controlled DVT/PE prevention trial.
Slovenian: Varnost zdravila Pradaxa je bila ocenjena v ključni študiji, v kateri so proučevali preprečevanje možganske kapi in sistemskih emboličnih dogodkov pri bolnikih z atrijsko fibrilacijo, v dveh aktivno nadzorovanih preskušanjih zdravila pri preprečevanju GVT/PE in v enem aktivno nadzorovanem preskušanju zdravila pri preprečevanju GVT/PE.
English: Pradaxa should be temporarily discontinued.
Slovenian: Zdravilo Pradaxa je treba začasno ukiniti.
English: 30 x 1 hard capsule
Slovenian: 30 x 1 trda kapsula
English: Major bleeding occurred in 0.97 per 100 patient-years.
Slovenian: Velika krvavitev se je pojavila pri 0,97 na 100 bolnik-let.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Slovenian: Neklinični podatki na osnovi običajnih študij farmakologije varnosti, toksičnosti ponavljajočih odmerkov in genotoksičnosti ne kažejo posebnega tveganja za človeka.
English: Do not take Pradaxa
Slovenian: Ne jemljite zdravila Pradaxa
English: Spinal anaesthesia/epidural anaesthesia/lumbar puncture
Slovenian: Spinalna anestezija/epiduralna anestezija/lumbalna punkcija
English: Clarithromycin When clarithromycin (500 mg twice daily) was administered together with dabigatran etexilate in healthy volunteers, increase of AUC by about 1.19-fold and Cmax by about 1.15-fold was observed.
Slovenian: Klaritromicin Ko so zdravim prostovoljcem dajali klaritromicin (500 mg 2-krat na dan) hkrati z dabigatran eteksilatom, se je AUC povečala za približno 1,19-krat, Cmax pa za približno 1,15-krat.
English: Coagulation tests may become unreliable following administration of suggested coagulation factor concentrates.
Slovenian: Po dajanju predlaganih koncentratov koagulacijskih faktorjev so lahko preskusi koagulacije nezanesljivi.
English: For dose modifications in this population see table 2 above.
Slovenian: Za spremembe odmerkov pri tej skupini bolnikov glejte preglednico 2 zgoraj.
English: Clopidogrel In young healthy male volunteers, the concomitant administration of dabigatran etexilate and clopidogrel resulted in no further prolongation of capillary bleeding times compared to clopidogrel monotherapy.
Slovenian: Klopidogrel Pri mladih zdravih prostovoljcih se pri sočasnem dajanju dabigatran eteksilata in klopidogrela čas kapilarne krvavitve v primerjavi z monoterapijo s klopidogrelom ni dodatno podaljšal.
English: In lifetime toxicology studies in rats and mice, there was no evidence for a tumorigenic potential of dabigatran up to maximum doses of 200 mg/kg.
Slovenian: V doživljenjskih toksikoloških študijah pri podaganah in miših niti pri dajanju največjih odmerkov do 200 mg/kg ni bilo znakov možnih tumorogenih učinkov dabigatrana.
English: No treatment experience is available for this subpopulation of patients, and therefore the use of Pradaxa is not recommended in this population.
Slovenian: Za to podskupino bolnikov ni izkušenj z zdravljenjem, zato uporabe zdravila Pradaxa za to skupino bolnikov ne priporočamo.
English: Almost half (45.8 %) of the RE-LY patients had a CrCL > 50-< 80 mL/min.
Slovenian: Pri skoraj polovici (45,8 %) bolnikov, ki jih je zajela študija RE-LY, je bil CrCl > 50 do < 80 ml/min.
English: Change of anticoagulant treatment
Slovenian: Zamenjava antikoagulacijskega zdravila
English: If you forget to take Pradaxa
Slovenian: Če ste pozabili vzeti zdravilo Pradaxa
English: A forgotten dose can still be taken up to 6 hours prior to the next due dose.
Slovenian: Pozabljeni odmerek lahko vzamete do 6 ur pred naslednjim odmerkom.
English: Dabigatran etexilate has not been clinically studied together with tacrolimus.
Slovenian: Dabigatran eteksilat skupaj s takrolimusom ni bil klinično raziskan.
English: After oral administration, dabigatran etexilate is rapidly and completely converted to dabigatran, which is the active form in plasma.
Slovenian: Po peroralni aplikaciji se dabigatran eteksilat hitro in povsem pretvori v dabigatran, ki je aktivna oblika zdravila v plazmi.
English: However, the aPTT test has limited sensitivity and is not suitable for precise quantification of anticoagulant effect, especially at high plasma concentrations of dabigatran.
Slovenian: Toda občutljivost tega preskusa je omejena, zato zlasti pri velikih koncentracijah dabigatrana ni primeren za natančno količinsko določanje antikoagulacijskega učinka.
English: Emergency surgery or urgent procedures
Slovenian: Nujna operacija ali nujni posegi
English: Patients at risk for bleeding or patients at risk of overexposure, notably patients with moderate renal impairment (CrCL 30-50 mL/min), should be treated with caution (see sections 4.4 and 5.1).
Slovenian: Bolnike, ki jih ogroža krvavitev ali pri katerih obstaja nevarnost prevelike izpostavljenosti, predvsem tiste z zmerno ledvično okvaro (CrCl 30-50 ml/min), je treba zdraviti previdno (glejte poglavji 4.4 in
English: If you are taking verapamil containing medicines, your doctor will tell you to use a reduced dose of Pradaxa.
Slovenian: če jemljete zdravila, ki vsebujejo verapamil, vam zdravnik lahko naroči, da uporabite zmanjšan odmerek zdravila Pradaxa.
English: No imbalance in the rate of heart attacks was observed in patients treated with dabigatran versus patients treated with placebo.
Slovenian: Glede na stopnjo srčnih napadov med bolniki, ki so se zdravili z dabigatranom, in bolniki, ki so prejemali placebo, ni bilo neravnovesja.
English: This study demonstrated that dual-therapy with dabigatran etexilate and a P2Y12 antagonist significantly reduced the risk of bleeding vs. warfarin triple-therapy with non-inferiority for composite of thromboembolic events in patients with atrial fibrillation who underwent a PCI with stenting.
Slovenian: Ta študija je pokazala, da dvojna terapija z dabigatran eteksilatom in antagonisti P2Y12 znatno zmanjša tveganje krvavitve v primerjavi s skupino s trojno terapijo z varfarinom, in neinferiornost sestavljenih trombemboličnih dogodkov pri bolnikih, ki so imeli perkutano koronarno intervencijo (PKI) z vstavitvijo žilne opornice.
English: Table 3: Duration of use for SPAF and DVT/PE Indication Duration of use
Slovenian: Preglednica 3: Trajanje uporabe za SPAF in GVT/PE Indikacija Trajanje uporabe
English: What you need to know before you take Pradaxa 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Pradaxa
English: EXP Once opened, the product must be used within 4 months.
Slovenian: EXP Po odprtju morate zdravilo porabiti v 4 mesecih.
English: Additionally, dabigatran exposure (at trough and peak) was assessed in a prospective open label randomized pharmacokinetic study in NVAF patients with severe renal impairment (defined as creatinine clearance [CrCl] 15-30 mL/min) receiving dabigatran etexilate 75 mg twice daily.
Slovenian: Poleg tega je bila izpostavljenost dabigatranu (pri najnižji in najvišji vrednosti) ocenjena v prospektivni odprti randomizirani farmakokinetični študiji pri bolnikih z nevalvularno atrijsko fibrilacijo (NVAF) z hudo ledvično okvaro (opredeljeno kot očistek kreatinina [CrCl] 15-30 ml/min), ki so prejemali 75 mg dabigatran eteksilata dvakrat na dan.
English: The greatest elevation of dabigatran exposure was observed with the first dose of an immediate release formulation of verapamil administered one hour prior to the dabigatran etexilate intake (increase of Cmax by about 2.8-fold and AUC by about 2.5-fold).
Slovenian: Izpostavljenost dabigatranu se je najbolj povečala po prvem odmerku verapamila s takojšnjim sproščanjem, apliciranega eno uro pred jemanjem dabigatran eteksilata (Cmax se je povečala za približno 2,8-krat, AUC pa za približno 2,5-krat).
English: The aPTT test is widely available and provides an approximate indication of the anticoagulation intensity achieved with dabigatran.
Slovenian: Preskus za določanje aPTČ je zelo dostopen in daje približno oceno jakosti dabigatranovega antikoagulacijskega učinka.
English: In the early post-operative patients, major bleeding manifested predominantly as haemorrhagic pericardial effusions, specifically in patients who started dabigatran etexilate early (i.e. on Day 3) after heart valve replacement surgery (see section 4.3).
Slovenian: Pri bolnikih v zgodnjem pooperativnem obdobju so pri velikih krvavitvah prevladovali hemoragični perikardialni izlivi, zlasti pri bolnikih, ki so dabigatran eteksilat začeli uporabljati zgodaj (to je 3. dan) po operativni vstavitvi umetne srčne zaklopke (glejte poglavje 4.3).
English: If a medical device (stent) has been deployed in a blood vessel to keep it open in a procedure called percutaneous coronary intervention with stenting, you can be treated with Pradaxa after your physician has decided that normal control of blood coagulation is achieved.
Slovenian: Če vam je bil v postopku, ki se mu reče koronarna intervencija za namestitev žilne opornice, nameščen medicinski pripomoček (žilna opornica) v krvno žilo, da bi jo ohranjal odprto, lahko zdravilo Pradaxa uporabljate šele, ko vaš zdravnik oceni, da je dosežen normalen nadzor strjevanja krvi.
English: Recurrent symptomatic VTE and all-cause deaths
Slovenian: Ponovitev simptomatske VTE in smrti vseh vzrokov
English: DVT/PE treatment (RECOVER, RE-COVER II)
Slovenian: Zdravljenje GVT/PE (RE COVER in RE COVER II)
English: Take Pradaxa exactly as prescribed.
Slovenian: Zdravilo Pradaxa jemljite natančno tako, kot vam je predpisal zdravnik.
English: Bleeding events for both treatments are counted from the first intake of Pradaxa or warfarin after the parenteral therapy has been discontinued (oral only treatment period).
Slovenian: Podatke o krvavitvah so za obe zdravili začeli zbirati od prvega dajanja zdravila Pradaxa ali varfarina po končanem parenteralnem zdravljenju (v obdobju, ko so bolniki prejemali samo peroralno zdravljenje).
English: If the treatment cannot be started until the day after surgery, dosing should be started with 2 capsules once a day.
Slovenian: Če zdravljenja ne morete začeti do naslednjega dne po operaciji, začnite z odmerjanjem po 2 kapsuli 1-krat na dan.
English: Table 2: Duration of use for SPAF and DVT/PE Indication Duration of use
Slovenian: Preglednica 2: Trajanje uporabe za SPAF in GVT/PE Indikacija Trajanje uporabe
English: The presence of lesions, conditions, procedures and/or pharmacological treatment (such as NSAIDs, antiplatelets, SSRIs and SNRIs, see section 4.5), which significantly increase the risk of major bleeding requires a careful benefit-risk assessment.
Slovenian: Pri poškodbah, bolezenskih stanjih, postopkih ali zdravljenju z zdravili (kot so NSAR, antitrombotiki, SSRI in SNRI, glejte poglavje 4.5), ki pomembno povečajo nevarnost velike krvavitve, je treba natančno presoditi o koristi in tveganju.
English: 60 x 1 hard capsule
Slovenian: 60 x 1 trda kapsula
English: No dose adjustment is necessary for concomitant use of amiodarone or quinidine (see sections 4.4, 4.5 and 5.2).
Slovenian: Odmerka ni potrebno prilagoditi za sočasno uporabo z amiodaronom ali kinidinom (glejte poglavja 4.4, 4.5 in 5.2).
English: Pradaxa treatment to parenteral anticoagulant:
Slovenian: Zamenjava zdravila Pradaxa s parenteralnim antikoagulantom:
English: Dabigatran is subject to conjugation forming pharmacologically active acylglucuronides.
Slovenian: Dabigatran se konjugira, pri čemer nastanejo farmakološko aktivni acilglukuronidi.
English: Excessive anticoagulation may require interruption of Pradaxa treatment.
Slovenian: Pri preveliki antikoagulaciji je včasih treba zdravljenje z zdravilom Pradaxa prekiniti.
English: ASA Co-administration of ASA and 150 mg dabigatran etexilate twice daily may increase the risk for any bleeding from 12 % to 18 % and 24 % with 81 mg and 325 mg ASA, respectively (see section 4.4).
Slovenian: ASA Sočasno jemanje ASK in 150 mg dabigatran eteksilata, dvakrat na dan, lahko poveča tveganje katere koli krvavitve z 12 na 18 % pri odmerku po 81 mg ASK in na 24 % pri odmerkih po 325 mg ASK (glejte poglavje 4.4).
English: After removal of a catheter, an interval of at least 2 hours should elapse before the administration of the first dose of Pradaxa.
Slovenian: Po odstranitvi katetra morata pred prvim odmerkom zdravila Pradaxa preteči najmanj 2 uri.
English: • The blister foil should only be peeled off, when a hard capsule is required.
Slovenian: • Folijo na pretisnem omotu odlepite šele, ko boste potrebovali trdo kapsulo.
English: 300 mg Pradaxa taken as one 150 mg capsule twice daily following treatment with a parenteral anticoagulant for at least 5 days
Slovenian: 300 mg zdravila Pradaxa, in sicer kot eno kapsulo po 150 mg, dvakrat na dan, po zdravljenju s parenteralnim antikoagulantom, ki naj traja najmanj 5 dni
English: The MAH shall provide an educational pack for each therapeutic indication, targeting all physicians who are expected to prescribe/use Pradaxa.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora za vsako terapevtsko indikacijo pripraviti izobraževalno gradivo za vse zdravnike, ki bodo predvidoma predpisovali ali uporabljali zdravilo
English: 18 months (%)
Slovenian: Pojavnost (%)
English: Because Pradaxa can impact the International Normalized Ratio (INR), the INR will better reflect VKA's effect only after Pradaxa has been stopped for at least 2 days.
Slovenian: Zdravilo Pradaxa lahko vpliva na mednarodno umerjeno razmerje (INR), zato bi bil učinek antagonista vitamina K z INR meritvijo merodajen šele 2 dni po ukinitvi zdravila Pradaxa.
English: According to the relatively low exposure, coagulation at 72 hrs (presumed dabigatran trough level at steady state or close to steady state conditions) was only slightly prolonged with aPTT at maximum 1.60 fold, ECT 1.86 fold, and Hemoclot
Slovenian: Ker je bila izpostavljenost zdravilu razmeroma majhna, je bila koagulacija po 72 urah (predvidena raven dabigatrana pred naslednjim odmerkom v ravnotežnem stanju ali blizu ravnotežnega stanja) le nekoliko podaljšana, in sicer aPTČ največ 1,60-krat, EKT 1,86-krat in Hemoclot
English: - if you have an increased bleeding risk, such as: if you have been recently bleeding.
Slovenian: - če je pri vas povečano tveganje za krvavitve, kot na primer:
English: What Pradaxa looks like and contents of the pack
Slovenian: Izgled zdravila Pradaxa in vsebina pakiranja
English: The median CrCL in RE-LY was 68.4 mL/min.
Slovenian: V študiji RE-LY je bila mediana vrednost CrCl 68,4 ml/min.
English: e.g. rifampicin, St. John´s wort (Hypericum perforatum), carbamazepine, or phenytoin
Slovenian: Na primer rifampicin, šentjanževka (Hypericum perforatum), karbamazepin ali fenitoin
English: A higher anti-FXa/FIIa activity was observed after dabigatran etexilate administration with enoxaparin pre-treatment compared to that after treatment with dabigatran etexilate alone.
Slovenian: Aktivnost anti-FXa/FIIa je bila po dajanju dabigatran eteksilata ob predzdravljenju z enoksaparinom večja kot po zdravljenju s samim dabigatran eteksilatom.
English: Tables 15-17 display details of key results in the overall population: Table 15: Analysis of first occurrence of stroke or systemic embolism (primary endpoint) during the study period in RE-LY. Pradaxa 110 mg twice daily
Slovenian: V preglednicah 15 do 17 so podrobno navedeni ključni podatki za vso populacijo: Preglednica 15: Analiza prvega pojava možganske kapi ali sistemskega emboličnega dogodka (primarni opazovani dogodek) v študiji RE-LY Zdravilo Pradaxa 110 mg dvakrat na dan
English: • After taking the capsule out, the cap should be returned on the bottle right away and the bottle should be tightly closed.
Slovenian: • Takoj, ko vzamete kapsulo ven, vrnite zaporko na plastenko in jo tesno zaprite.
English: Totals of 2,076 patients (knee) and 3,494 (hip) were treated respectively.
Slovenian: Skupno število zdravljenih bolnikov je bilo 2076 (koleno) oziroma 3494 (kolk).
English: The concomitant use of dabigatran etexilate with the fixed-dose combination of the P-gp inhibitors glecaprevir/pibrentasvir has been shown to increase exposure of dabigatran and may increase the risk of bleeding.
Slovenian: Pokazalo se je, da sočasno dajanje dabigatran eteksilata s fiksno kombinacijo zaviralcev P-gp, glekaprevirja/pibrentasvirja, poveča izpostavljenost dabigatranu in lahko poveča tveganje za krvavitev.
English: There is no relevant use of Pradaxa in the paediatric population for the indication of prevention of stroke and systemic embolism in patients with NVAF.
Slovenian: Za pediatrično populacijo uporaba zdravila Pradaxa pri indikaciji preprečevanje možganske kapi in sistemske embolije pri bolnikih z NVAF ni relevantna.