FrancophonIA/ELRC3.0 huggingface dataset:
English: Limited clinical data in patients < 50 kg are available.
Slovenian: Za bolnike s telesno maso 50 kg ali manj je na voljo malo kliničnih podatkov.
English: INFORMATION IN BRAILLE Pradaxa 150 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pradaxa 150 mg
English: Primary prevention of venous thromboembolism in orthopaedic surgery
Slovenian: Primarno preprečevanje venske trombembolije pri ortopedski operaciji
English: Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.
Slovenian: Primarno preprečevanje venskih trombemboličnih dogodkov pri odraslih bolnikih po operativni vstavitvi umetnega kolka ali kolena.
English: Dronedarone When dabigatran etexilate and dronedarone were given at the same time total dabigatran AUC0-∞ and Cmax values increased by about 2.4-fold and 2.3-fold, respectively, after multiple dosing of 400 mg dronedarone bid, and about 2.1-fold and 1.9-fold, respectively, after a single dose of 400 mg.
Slovenian: Dronedaron Ob sočasnem dajanju dabigatran eteksilata in dronedarona ob istem času, sta se AUC0-∞ in Cmax dabigatrana povečali približno 2,4-krat oziroma 2,3-krat, po večkratnem dajanju po 400 mg dronedarona dvakrat na dan in približno 2,1-krat oziroma 1,9-krat po dajanju enkratnega odmerka po 400 mg.
English: Swallow whole, do not chew or break the capsule.
Slovenian: Kapsule pogoltnite cele, ne žvečite in ne lomite.
English: Known bleeding complications such as compartment syndrome and acute renal failure due to hypoperfusion have been reported for Pradaxa.
Slovenian: Za zdravilo Pradaxa so poročali o znanih zapletih zaradi krvavitev, kot so utesnitveni sindrom in akutna ledvična odpoved zaradi hipoperfuzije.
English: Bottle: Once opened, the medicine must be used within 4 months.
Slovenian: Po odprtju morate zdravilo porabiti v 4 mesecih.
English: With chronic use in the RE-LY study, NSAIDs increased the risk of bleeding by approximately 50 % on both dabigatran etexilate and warfarin.
Slovenian: Pri kronični uporabi NSAR se je v študiji RE-LY tveganje krvavitev ob dajanju dabigatran eteksilata in varfarina povečalo za 50 %.
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 180 (3 packs of 60x1) hard capsules.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Večkratno pakiranje: 180 (3 enotei po 60 x 1) trdih kapsul.
English: Further risk factors (see also table 3) comprise co-medication with 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.
Slovenian: Nadaljnji dejavniki tveganja (glejte tudi preglednico 3) so tudi sočasno zdravljenje z zaviralci agregacije trombocitov, kot sta klopidogrel in acetilsalicilna kislina (ASK), ali nesteroidnimi antirevmatiki (NSAR) in prisotnost ezofagitisa, gastritisa ali gastroezofagealnega refluksa
English: NAME OF THE MEDICINAL PRODUCT Pradaxa 75 mg hard capsules
Slovenian: IME ZDRAVILA Pradaxa 75 mg trde kapsule
English: 1-2 days before
Slovenian: 1 do 2 dni pred
English: Multipack containing 2 packs of 50 x 1 hard capsules (100 hard capsules) in perforated aluminium unit dose blisters.
Slovenian: Večkratno pakiranje z 2 enotama po 50 x 1 trda kapsula (100 trdih kapsul) v perforiranih aluminijastih pretisnih omotih za enkratni odmerek.
English: Patients who receive concomitant verapamil Dose reduction for consideration Patients between 75-80 years daily dose of Pradaxa of 300 mg or 220 mg should be selected based on an individual assessment of the thromboembolic risk and the risk of bleeding
Slovenian: Dnevni odmerek zdravila Pradaxa po 300 mg ali 220 mg je treba izbrati glede na individualno oceno tveganja trombembolije in tveganja krvavitve
English: Data for the total VTE and all cause mortality endpoint are shown in table 11.
Slovenian: Podatki o opazovanem dogodku skupna pogostnost venskih trombemboličnih dogodkov in umrljivost iz vseh vzrokov so navedeni v preglednici 11.
English: ® without talking to your doctor, if you experience heartburn, nausea, vomiting, stomach discomfort, bloating or upper abdominal pain.
Slovenian: ® ne prenehajte jemati, ne da bi se o tem pogovorili z zdravnikom, če se pri vas pojavi zgaga, navzea, bruhanje, neprijeten občutek v želodcu, napenjanje ali bolečine v zgornjem delu trebuha.
English: • Thrombocytopenia or functional platelet defects
Slovenian: • trombocitopenija ali okvare delovanja trombocitov
English: Concomitant administration of a loading dose of 180 mg ticagrelor and 110 mg dabigatran etexilate (in steady state) increased the dabigatran AUCτ,ss and Cmax,ss by 1.49-fold and 1.65-fold, respectively, compared with dabigatran etexilate given alone.
Slovenian: Pri sočasnem dajanju polnilnega odmerka tikagrelorja po 180 mg in dabigatran eteksilata po 110 mg (v stanju dinamičnega ravnovesja) sta se AUCτ,ss in Cmax,ss dabigatrana v primerjavi z dajanjem samega dabigatran eteksilata povečali, in sicer za 1,49-krat oziroma 1,65-krat.
English: The concomitant use of antiplatelets ASA or clopidogrel approximately doubles MBE rates with both dabigatran etexilate and warfarin.
Slovenian: Sočasna uporaba antitrombotikov ASK ali klopidogrela približno podvoji število večjih dogodkov s krvavitvijo, tako pri dabigatran eteksilatu kot varfarinu.
English: - Medicines to prevent organ rejection after transplantation (e.g. tacrolimus, cyclosporine) - A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C) - Anti-inflammatory and pain reliever medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac) - St. John´s wort, a herbal medicine for depression - Antidepressant medicines called selective serotonin re-uptake inhibitors or serotonin norepinephrine re-uptake inhibitors - Rifampicin or clarithromycin (two antibiotics) - Anti-viral medicines for AIDS (e.g. ritonavir) - Certain medicines for treatment of epilepsy (e.g. carbamazepine, phenytoin)
Slovenian: Glejte poglavje 3; - zdravila za preprečitev zavrnitve organa po presaditvi (npr. takrolimus, ciklosporin), - zdravila, ki vsebujejo kombinacijo glekaprevirja in pibrentasvirja (protivirusno zdravilo za zdravljenje hepatitisa C); - protivnetna in protibolečinska zdravila (npr. acetilsalicilna kislina, ibuprofen, diklofenak), - šentjanževko, zeliščno zdravilo proti depresiji; - antidepresive, poimenovane selektivni zaviralci ponovnega privzema serotonina ali zaviralci ponovnega privzema serotonina in noradrenalina; - rifampicin ali klaritromicin (dva antibiotika), - protivirusna zdravila za zdravljenje aidsa (npr. ritonavir), - nekatera zdravila za zdravljenje epilepsije (npr. karbamazepin, fenitoin).
English: The objective of the RE-SONATE study was to evaluate superiority of dabigatran etexilate versus placebo for the prevention of recurrent symptomatic DVT and/or PE in patients who had already completed 6 to 18 months of treatment with VKA.
Slovenian: Cilj študije RE-SONATE je bil oceniti superiornost dabigatran eteksilata v primerjavi s placebom pri preprečevanju ponovitve simptomatične GVT in/ali PE pri bolnikih, ki so že končali 6- do 18-mesečno zdravljenje z antagonisti vitamina K. Predvideno zdravljenje je bilo 6 mesecev jemanja dabigatran eteksilata po 150 mg dvakrat na dan brez spremljanja.
English: Subjects randomized All-cause mortality Incidences (%) Hazard ratio vs. warfarin (95 % CI) p-value Vascular mortality Incidences (%) Hazard ratio vs. warfarin (95 % CI) p-value % refers to yearly event rate
Slovenian: Umrljivost iz vseh vzrokov Pojavnost (%) Razmerje ogroženosti v primerjavi z varfarinom (95odstotni IZ) Vrednost p Žilna umrljivost Pojavnost (%) Razmerje ogroženosti v primerjavi z varfarinom (95odstotni IZ) Vrednost p % pomeni letni odstotek dogodkov
English: Half-life is prolonged if renal function is impaired as shown in table 13.
Slovenian: Pri okvarjenem ledvičnem delovanju je razpolovna doba podaljšana, kot je navedeno v preglednici 13.
English: Pradaxa 110 mg are hard capsules with an opaque, light blue-coloured cap and an opaque, light blue -coloured body.
Slovenian: Zdravilo Pradaxa 110 mg so trde kapsule z neprozornim, svetlo modrim pokrovčkom in neprozornim svetlo modrim telesom.
English: Pradaxa 150 mg are hard capsules with an opaque, light blue-coloured cap and an opaque, white body.
Slovenian: Zdravilo Pradaxa 150 mg so trde kapsule z neprozornim, svetlo modrim pokrovčkom in neprozornim belim telesom.
English: See section 3.
Slovenian: Preglednica 13.
English: Cartons containing 10 x 1, 30 x 1 or 60 x 1 hard capsules in perforated aluminium unit dose blisters.
Slovenian: Škatle po 10 x 1, 30 x 1 ali 60 x 1 trda kapsula v perforiranih aluminijastih pretisnih omotih za enkratni odmerek.
English: Symptomatic PE
Slovenian: Vrednost p
English: Pradaxa treatment should be resumed / startedafter the invasive procedure or surgical intervention as soon as possible provided the clinical situation allows and adequate haemostasis has been established.
Slovenian: Po invazivnem postopku ali kirurškem posegu je treba zdravljenje z zdravilom Pradaxa nadaljevati/uvesti takoj, ko nam klinične razmere omogočajo in je vzpostavljena primerna hemostaza.
English: Table 18: Hazard Ratio and 95 % CI for stroke/systemic embolism by subgroups
Slovenian: Preglednica 18: Razmerje ogroženosti in 95-odstotni IZ za možgansko kap ali sistemske embolične dogodke po podskupinah
English: During the additional 2.5 years of treatment in RELY-ABLE, with a maximum exposure of over 6 years (total exposure in RELY + RELY-ABLE), the long-term safety profile of dabigatran etexilate was confirmed for both test doses 110 mg b.i.d.
Slovenian: Dodatno 2,5-letno obdobje zdravljenja v podaljšku RELY-ABLE je ob največji izpostavljenosti v skupno več kot 6 let dolgem obdobju (skupna izpostavljenost v študijah RELY in RELY-ABLE) potrdilo dolgoročne varnostne lastnosti dabigatran eteksilata za oba preizkušana odmerka, in sicer 100 mg 2-krat na dan in 150 mg 2-krat na dan. Novih z varnostjo povezanih ugotovitev ni bilo.
English: The objective of the RE-MEDY study was to compare the safety and efficacy of oral dabigatran etexilate (150 mg bid) to warfarin (target INR 2.0-3.0) for the long-term treatment and prevention of recurrent, symptomatic DVT and/or PE. A total of 2,866 patients were randomized and 2,856 patients were treated.
Slovenian: Cilj študije RE-MEDY je bil primerjati varnost in učinkovitost peroralnega dabigatran eteksilata (po 150 mg dvakrat na dan) z varnostjo in učinkovitostjo varfarina (ciljni INR 2,0 do 3,0) pri dolgotrajnem zdravljenju in preprečevanju ponovitev simptomatične GVT in/ali PE.
English: Capsules with light blue, opaque cap and white, opaque body of size 0 filled with yellowish pellets.
Slovenian: Potiskane kapsule s svetlo modrim, neprozornim pokrovčkom in belim telesom, velikosti 0, napolnjene z rumenkastimi peletami.
English: You should start treatment with Pradaxa within 1-4 hours after surgery finishes, taking a single capsule.
Slovenian: Zdravljenje z zdravilom Pradaxa je treba začeti 1 do 4 ure po končani operaciji, in sicer z eno kapsulo in ga nadaljevati z dvema kapsulama 1-krat na dan 10 dni.
English: The table 9 shows the number (%) of patients experiencing the adverse reaction bleeding during the treatment period in the VTE prevention in the two pivotal clinical trials, according to dose.
Slovenian: V preglednici 9 je za različna odmerka navedeno število (%) bolnikov, ki so imeli v dveh ključnih kliničnih študijah preprečevanja VTE med zdravljenjem neželeni učinek krvavitev.
English: Not applicable.
Slovenian: ga ne določamo
English: Table 24: Hazard Ratio and 95 % CI for major bleeds by subgroups Endpoint
Slovenian: Preglednica 24: Razmerje ogroženosti in 95-odstotni IZ za velike krvavitve po podskupinah
English: Pradaxa 150 mg once daily
Slovenian: Zdravilo Pradaxa 150 mg enkrat dnevno
English: Hazard ratio vs placebo (95% confidence interval)
Slovenian: Razmerje ogroženosti v primerjavi s placebom (95-odstotni interval zaupanja)
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 100 (2 packs of 50x1) hard capsules.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Večkratno pakiranje: 100 (2 enoti po 50 x 1) trdih kapsul.
English: Table 11: Bleeding events in a study testing the prevention of thromboembolic stroke and systemic embolism in patients with atrial fibrillation
Slovenian: Preglednica 11: Dogodki krvavitev v študiji, v kateri so proučevali preprečevanje trombembolične možganske kapi in sistemskih emboličnih dogodkov pri bolnikih z atrijsko fibrilacijo
English: Major bleeding rates with this dose were comparable to warfarin.
Slovenian: Odstotek velikih krvavitev je bil ob tem odmerku primerljiv z njihovim odstotkom pri uporabi varfarina.
English: Polypropylene bottle with a screw cap containing 60 hard capsules.
Slovenian: Plastenka iz propilena z navojno zaporko s 60 trdimi kapsulami.
English: Table 13: Bleeding events in a study testing the prevention of thromboembolic stroke and systemic embolism in patients with atrial fibrillation
Slovenian: Preglednica 13: Dogodki krvavitev v študiji, v kateri so proučevali preprečevanje trombembolične možganske kapi in sistemskih emboličnih dogodkov pri bolnikih z atrijsko fibrilacijo
English: In patients treated for prevention of VTEs after hip or knee replacement surgery with 220 mg dabigatran etexilate once daily,
Slovenian: Pri bolnikih, ki so za preprečitev venske trombembolije po operativni vstavitvi umetnega kolka ali kolena prejemali 220 mg dabigatran eteksilata enkrat na dan, je bil:
English: Table 19: Major bleeding events by treatment in the individual RE-MODEL and the RE-NOVATE studies.
Slovenian: Preglednica 19.: Večji dogodki s krvavitvijo pri zdravljenju v študijah RE-MODEL in RENOVATE
English: Parenteral anticoagulants to Pradaxa:
Slovenian: Zamenjava parenteralnega antikoagulanta z zdravilom Pradaxa:
English: Table 23: Hazard Ratio and 95 % CI for stroke/systemic embolism by subgroups
Slovenian: Preglednica 23: Razmerje ogroženosti in 95-odstotni IZ za možgansko kap ali sistemske embolične dogodke po podskupinah
English: Pradaxa 75 mg hard capsules are also available in polypropylene (plastic) bottles with 60 hard capsules.
Slovenian: Pradaxa 75 mg trde kapsule so na voljo tudi v polipropilenski plastenki po 60 trdih kapsul.
English: ECT [x-fold upper limit of normal] aPTT [x-fold upper limit of normal] INR
Slovenian: EKT [x-kratna zgornja meja normalne vrednosti] aPTČ [x-kratna zgornja meja normalne vrednosti]
English: Irrespective of therapy, the highest absolute risk of MI was seen in the following subgroups, with similar relative risk: patients with previous MI, patients ≥ 65 years with either diabetes or coronary artery disease, patients with left ventricular ejection fraction < 40 %, and patients with moderate renal dysfunction.
Slovenian: To so bolniki s prebolelim miokardnim infarktom; stari 65 let in starejši; s sladkorno boleznijo ali koronarno arterijsko boleznijo, z iztisnim deležem levega prekata < 40 %; in bolniki z zmerno ledvično disfunkcijo.
English: Prevention of brain or body vessel obstruction by blood clot formation developing after abnormal heart beats
Slovenian: Preprečevanje zapore krvnih žil v možganih ali telesu s krvnimi strdki, ki se razvijejo pri motnjah srčnega utripa
English: treat blood clots in the veins of your legs and lungs and to prevent blood clots from reoccurring in the vein of your legs and lungs.
Slovenian: - zdravljenje krvnih strdkov v venah nog in pljučih ter za preprečevanje ponovnega pojava krvnih strdkov v nožnih venah in pljučih.
English: P-gp substrate Digoxin
Slovenian: Substrat P-gp
English: Multipack containing 3 packs of 60 x 1 hard capsules (180 hard capsules) in perforated aluminium unit dose blisters.
Slovenian: Večkratno pakiranje s 3 enotami po 60 x 1 trda kapsula (180 trdih kapsul) v perforiranih aluminijastih pretisnih omotih za enkratni odmerek.
English: Patient alert card inside.
Slovenian: Priložena je opozorilna kartica za bolnika.
English: When a loading dose of 180 mg ticagrelor was given 2 hours after 110 mg dabigatran etexilate (in steady state), the increase of dabigatran AUCτ,ss and Cmax,ss was reduced to 1.27-fold and 1.23-fold, respectively, compared with dabigatran etexilate given alone.
Slovenian: Pri dajanju polnilnega odmerka tikagrelorja po 180 mg dve uri po dajanju odmerka dabigatran eteksilata po 110 mg (v stanju dinamičnega ravnovesja) sta se AUCτ,ss in Cmax,ss dabigatrana v primerjavi z dajanjem samega dabigatrana povečali manj, in sicer za 1,27-krat oziroma 1,23-krat.
English: NAME OF THE MEDICINAL PRODUCT Pradaxa 110 mg hard capsules
Slovenian: IME ZDRAVILA Pradaxa 110 mg trde kapsule
English: Prevention of brain or body vessel obstruction by blood clot formation developing after abnormal heart beats and Treatment of blood clots in the veins of your legs and lungs including prevention of blood clots from re-occurring in the vein of your legs and lungs
Slovenian: Preprečevanje zapore krvnih žil v možganih ali telesu s krvnimi strdki, ki se razvijejo pri motnjah srčnega utripa, in zdravljenje krvnih strdkov v venah nog in pljučih ter preprečevanje njihove ponovitve
English: Table 19: Hazard Ratio and 95 % CI for major bleeds by subgroups Endpoint
Slovenian: Preglednica 19: Razmerje ogroženosti in 95-odstotni IZ za velike krvavitve po podskupinah
English: You may need to be checked by a doctor, as you may be at increased risk of bleeding.
Slovenian: Zaradi povečane nevarnosti krvavitve vas bo moral pregledati zdravnik.
English: With chronic use, NSAIDs increased the risk of bleeding by approximately 50 % on both dabigatran etexilate and warfarin.
Slovenian: Pri kronični uporabi NSAR se je tveganje krvavitev ob dajanju dabigatran eteksilata in varfarina povečalo za 50 %.
English: -if an operation involves a catheter or injection into your spinal column (e.g. for epidural or spinal anaesthesia or pain reduction): it is very important to take Pradaxa before and after the operation exactly at the times you have been told by your doctor.
Slovenian: - če operacija vključuje kateter ali injekcijo v hrbtenico (npr. za epiduralno ali spinalno anestezijo ali zmanjšanje bolečin): - zelo pomembno je, da zdravilo Pradaxa vzamete pred in po operaciji točno takrat, ko vam naroči zdravnik; - takoj obvestite svojega zdravnika, če po koncu anestezije začutite otrplost ali oslabelost nog ali imate težave s črevesjem ali mehurjem, saj je potrebna nujna oskrba.
English: Anticoagulants and antiplatelet aggregation medicinal products
Slovenian: Antikoagulanti in zaviralci agregacije trombocitov
English: The incidence of the primary endpoint was 15.4 % (151 patients) in the dabigatran etexilate 110 mg dual-therapy group as compared with 26.9 % (264 patients) in the warfarin triple-therapy group (HR 0.52; 95% CI 0.42, 0.63; P<0.0001 for non-inferiority and P<0.0001 for superiority) and 20.2 % (154 patients) in the dabigatran etexilate 150 mg dual-therapy group as compared with 25.7 % (196 patients) in the corresponding warfarin triple-therapy group (HR 0.72; 95% CI 0.58, 0.88; P<0.0001 for non-inferiority and P=0.002 for superiority).
Slovenian: Incidenca primarnega opazovanega dogodka je bila 15,4 % (151 bolnikov) v skupini z dvojno terapijo z dabigatran eteksilatom 110 mg v primerjavi s 26,9 % (264 bolnikov) v skupini s trojno terapijo z varfarinom (RO 0,52; 95-% IZ 0,42; 0,63; P < 0,0001 za neinferiornost in P < 0,0001 za superiornost) in 20,2 % (154 bolnikov) v skupini z dvojno terapijo z dabigatran eteksilatom 150 mg v primerjavi s 25,7 % (196 bolnikov) v ustrezni skupini s trojno terapijo z varfarinom (RO 0,72; 95-% IZ 0,58; 0,88; P < 0,0001 za neinferiornost in P = 0,002 za superiornost).
English: The absolute bioavailability of dabigatran following oral administration of Pradaxa was approximately
Slovenian: Absolutna biološka uporabnost dabigatrana je bila po peroralni aplikaciji zdravila Pradaxa približno 6,5 %.
English: Test (trough value)
Slovenian: Preskus (najnižja vrednost)
English: You should not breast-feed while you are taking Pradaxa.
Slovenian: Med jemanjem zdravila Pradaxa ne smete dojiti.
English: When excessive dabigatran exposure is identified in patients at high risk of bleeding, a reduced dose of 220 mg taken as one 110 mg capsule twice daily is recommended.
Slovenian: Če je izpostavljenost dabigatranu pri bolnikih z velikim tveganjem krvavitve povečana, je zanje priporočen zmanjšan odmerek 220 mg, to je ena kapsula po 110 mg dvakrat na dan.
English: PHARMACEUTICAL FORM AND CONTENTS 50x1 hard capsules.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 50 x 1 trda kapsula.
English: The table 11 shows bleeding events broken down to major and any bleeding in the pivotal study testing the prevention of thromboembolic stroke and systemic embolism in patients with atrial fibrillation.
Slovenian: V preglednici 11 so navedene krvavitve, razdeljene na velike in vse krvavitve, iz ključne študije, v kateri so proučevali preprečevanje trombembolične možganske kapi in sistemskih emboličnih dogodkov pri bolnikih z atrijsko fibrilacijo.
English: Close observation for signs of bleeding or anaemia is recommended throughout the treatment period, especially if risk factors are combined (see table 2 above).
Slovenian: Za odkrivanje znakov krvavitev ali anemije, priporočamo pozorno spremljanje ves čas zdravljenja, še zlasti pri kombinaciji dejavnikov tveganja (glejte zgornjo preglednico 2).
English: Subjects randomized to 110 mg Pradaxa twice daily had a significantly lower risk for major bleeds compared with warfarin (hazard ratio 0.81 [p=0.0027]).
Slovenian: Pri preizkušancih, ki so bili naključno uvrščeni v zdravljenje z zdravilom Pradaxa po 110 mg dvakrat na dan, je bilo tveganje večjih krvavitev značilno manjše kot v skupini, ki je jemala varfarin (razmerje tveganja 0,81 [p = 0,0027]).
English: SOC / Preferred term.
Slovenian: Organski sistem / prednostno poimenovanje
English: See section 4.
Slovenian: Preglednica 10.
English: 300 mg Pradaxa taken as one 150 mg capsule twice daily
Slovenian: 300 mg zdravila Pradaxa, in sicer kot eno kapsulo po 150 mg, dvakrat na dan
English: Pradaxa doses beyond those recommended expose the patient to increased risk of bleeding.
Slovenian: Odmerki zdravila Pradaxa, ki so večji od priporočenega odmerka, povečajo nevarnost krvavitve.
English: More thromboembolic events (mainly strokes and symptomatic/asymptomatic prosthetic valve thrombosis) and more bleeding events were observed with dabigatran etexilate than with warfarin.
Slovenian: V primerjavi z varfarinom so pri dabigatran eteksilatu opazili več trombemboličnih dogodkov (predvsem možganskih kapi in simptomatskih/ asimptomatskih tromboz povezanih z vstavitvijo umetne zaklopke) in krvavitev.
English: - The active substance is dabigatran.
Slovenian: Zdravilna učinkovina je dabigatran.
English: This risk of bleeding should be weighed against the urgency of intervention.
Slovenian: Če operacije ni mogoče odložiti, lahko obstaja povečano tveganje krvavitve, o katerem je treba presoditi glede na nujnost intervencije.
English: RE-MEDY demonstrated that treatment with dabigatran etexilate 150 mg twice daily was non-inferior to warfarin (non-inferiority margin: 2.85 for hazard ratio and 2.8 for risk difference).
Slovenian: Izsledki študije RE-MEDY so pokazali, da je zdravljenje z dabigatran eteksilatom v odmerkih po 150 mg dvakrat na dan enakovredno tistemu z varfarinom (meja enakovrednosti: 2,85 za razmerje ogroženosti in 2,8 za razliko pri tveganosti).
English: They have not been studied and are therefore not recommended for concomitant treatment with Pradaxa.
Slovenian: Ker jih niso raziskovali, sočasno dajanje z zdravilom Pradaxa odsvetujejo.
English: Treated Major bleeding Any bleeding
Slovenian: Zdravljeni Večja krvavitev Vse krvavitve
English: Pradaxa 110 mg hard capsules are also available in polypropylene (plastic) bottles with 60 hard capsules.
Slovenian: Pradaxa 110 mg trde kapsule so na voljo tudi v polipropilenski plastenki po 60 trdih kapsul.