natgillin/translations-raw huggingface dataset:
The efficacy and safety have not been established for DVT/PE patients with active cancer.
Učinkovitost in varnost zdravila pri bolnikih z GVT ali PE in aktivnim rakom še nista raziskani.
Patients at high surgical mortality risk and with intrinsic risk factors for thromboembolic events
Bolniki z velikim tveganjem umrljivosti med operacijo in intrinzičnimi dejavniki tveganja za trombembolične dogodke
Both dose strengths of Pradaxa had also a statistically significant lower total bleed rate.
Pri obeh jakostih zdravila Pradaxa je bil statistično značilno manjši tudi odstotek vseh krvavitev.
® may need to be stopped in advance of surgical or other invasive procedures.
® bo morda treba ukiniti pred operacijami in drugimi invazivnimi postopki.
• 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).
• 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).
Blister and bottle 3 years
Pretisni omot in plastenka 3 leta
RELY-ABLE (Long term multi-center extension of dabigatran treatment in patients with atrial fibrillation who completed the RE-LY trial)
Študija RELY-ABLE (dolgotrajen, multicentrični podaljšek zdravljenja z dabigatranom pri bolnikih z atrijsko fibrilacijo po končani študiji RE-LY)
Pharmacodynamic and kinetic factors
Farmakodinamični in kinetični dejavniki
Since dabigatran is excreted predominantly by the renal route adequate diuresis must be maintained.
Ker se dabigatran pretežno izloča preko ledvic, moramo vzdrževati ustrezno diurezo.
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
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
• Details of populations potentially at higher risk of bleeding
• Podroben opis populacij, pri katerih je lahko povečano tveganje krvavitev
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).
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).
None of these diseases showed an impact on the effects of dabigatran on VTE-prevention or bleeding rates.
Nobena od naštetih bolezni ni vplivala na učinkovitost dabigatrana pri preprečevanju venskih trombemboličnih dogodkov ali stopnjo krvavitve.
The median CrCL in the RE-COVER study was 100.4 mL/min.
Mediana CrCl je bila v študiji RE-COVER 100,4 ml/min.
• In case of major bleeding events, Pradaxa ® must be stopped immediately.
• Pri večjih krvavitvah je treba zdravilo Pradaxa ® nemudoma ukiniti.
Clearance of dabigatran in patients with renal insufficiency may take longer (see section 5.2).
Pri bolnikih z ledvično insuficienco se lahko podaljša dabigatranov očistek (glejte poglavje 5.2).
Clearance of dabigatran by haemodialysis was investigated in 7 patients with end-stage renal disease (ESRD) without atrial fibrillation.
Očistek dabigatrana med hemodializo so proučevali pri 7 bolnikih s končnim stadijem ledvične bolezni in brez atrijske fibrilacije.
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.
Preprečevanje nastajanja krvnih strdkov po operativni vstavitvi umetnega kolena ali kolka Nadaljujte s preostalim dnevnim odmerkom zdravila Pradaxa ob istem času naslednjega dne.
Metabolism and excretion of dabigatran were studied following a single intravenous dose of radiolabeled dabigatran in healthy male subjects.
Presnavljanje in izločanje dabigatrana so raziskovali po enkratnem intravenskem odmerku radioaktivno označenega dabigatrana pri zdravih moških.
• Do not push the capsules through the blister foil.
• Kapsul ne potiskajte skozi pretisno folijo.
-if you fall or injure yourself during treatment, especially if you hit your head.Please seek urgent medical attention.
-če med zdravljenjem padete ali se poškodujete, zlasti če se udarite v glavo.Poiščite nujno medicinsko pomoč.
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).
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)
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).
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).
Other patients at increased risk of bleeding
Drugi bolniki s povečanim tveganjem krvavitve
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.
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.
Patients with gastritis, esophagitis or gastroesophageal reflux
Bolniki z gastritisom, ezofagitisom ali gastroezofagealnim refluksom
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).
GVT/PE Trajanje zdravljenja je treba po skrbni presoji med koristijo zdravljenja in tveganjem krvavitve individualno prilagoditi (glejte poglavje 4.4).
All bleeding events which occurred during warfarin therapy are included except for those during the overlap period between warfarin and parenteral therapy.
Zajete so tudi vse krvavitve, ki so je pojavile med zdravljenjem z varfarinom, razen reakcij v obdobju prekrivanja zdravljenja z varfarinom in parenteralnega zdravljenja.
- Medicines to reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin,
- zdravila za zmanjšanje nastajanja krvnih strdkov (npr. varfarin, fenprokoumon, acenokumarol,
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.
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.
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.
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.
Pradaxa should be stopped before elective surgery High risk of bleeding or major surgery
Zdravilo Pradaxa je potrebno ukiniti pred elektivnim kirurškim posegom Veliko tveganje krvavitve ali večja operacija
No clinically relevant ethnic differences among Caucasians, African-American, Hispanic, Japanese or Chinese patients were observed.
Med belci, Afroameričani, hispani, Japonci in Kitajci ni bilo klinično pomembnih razlik.
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.
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.
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).
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).
The clinical studies have been conducted in a patient population with a mean age > 65 years.
Srednja starost populacije bolnikov v študijah je bila > 65 let.
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).
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).
if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen,piroxicam.
• če jemljete protivnetna zdravila, kot so diklofenak, ibuprofen, piroksikam;
Pradaxa affects blood clotting, so most side effects are related to signs such as bruising or bleeding.
Zdravilo Pradaxa učinkuje na strjevanje krvi, zato se pri večini neželenih učinkov pojavljajo znaki, kot so modrice ali krvavitve.
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.
Zdravilo Pradaxa lahko bolnik ponovno prejme 24 ur po dajanju zdravila Praxbind (idarucizumab), če je njegovo klinično stanje stabilno in je zagotovljena ustrezna hemostaza.
No other effects on female fertility were observed.
Drugih učinkov na plodnost samic niso ugotovili.
-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.
- če imate jetrno bolezen, ki je povezana s spremenjenimi izvidi krvnih preiskav, uporabe zdravila Pradaxa ne priporočamo.
Continue with your remaining daily doses of Pradaxa at the same time of the next day.
Nadaljujte s preostalim dnevnim odmerkom zdravila Pradaxa ob istem času naslednjega dne.
Tacrolimus has been found in vitro to have a similar level of inhibitory effect on Pgp as that seen with itraconazole and cyclosporine.
Ugotovljeno je bilo, da je imel takrolimus in vitro podoben zaviralni učinek na P-gp kot je bil opažen pri itrakonazolu in ciklosporinu.
METHOD AND ROUTE(S) OF ADMINISTRATION Swallow whole, do not chew or break the capsule.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Kapsule pogoltnite cele, ne žvečite in ne lomite.
No difference was found for major bleeding (hazard ratio 0.97, CI 0.88 - 1.07).
Glede večjih krvavitev niso opazili razlik (razmerje tveganja 0,97, IZ 0,88
The MAH shall also provide a patient alert card in each medication pack, the text of which is included in Annex III.
Imetnik dovoljenja za promet z zdravilom mora vvsakempakiranjuzagotoviti opozorilnokartico za bolnika, katerebesedilo se nahaja v prilogi III.
Peel off the backing foil and remove the capsule.
Odlepite zaščitno folijo in vzemite ven kapsulo.
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.
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.
® thins the blood, which prevents you from getting dangerous bood clots.
® redči kri, kar preprečuje nastajanje nevarnih krvnih strdkov.
Dose reductions may be required in combination with some P-gp inhibitors (see sections 4.2, 4.3, 4.4 and 5.1).
V kombinaciji z nekaterimi zaviralci P-gp so lahko potrebna zmanjšanja odmerkov (glejte poglavja 4.2, 4.3, 4.4 in 5.1).
There is limited amount of data from the use of Pradaxa in pregnant women.
Podatki o uporabi zdravila Pradaxa pri nosečnicah so omejeni.
A dose reduction should be either considered or is recommended as indicated in section 4.2.
Vredno je razmisliti o zmanjšanju odmerka oziroma je zmanjšanje odmerka priporočeno, kot je navedeno v poglavju 4.2.
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).
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).
The method to be used to estimate renal function (CrCL in mL/min) is the Cockcroft-Gault method.
Ledvično delovanje (CrCl v ml/min) je treba oceniti po Cockcroft-Gaultovi metodi.
If treatment is not started on the day of surgery then treatment should be initiated with 2 capsules once daily.
Če zdravljenja ne uvedemo na dan operacije, ga moramo začeti z 2 kapsulama 1-krat na dan.
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).
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).
Cautions to be exercised in case concomitant use (see sections 4.2 and 4.4)
V primeru sočasne uporabe je potrebna previdnost (glejte poglavji 4.2 in 4.4)
Pradaxa treatment should not be discontinued without medical advice.
Zdravila Pradaxa se ne sme prenehati jemati brez posveta z zdravnikom.
It is recommended to continue with the remaining daily doses of Pradaxa at the same time of the next day.
Priporočeno je nadaljevati z jemanjem preostalih dnevnih odmerkov zdravila Pradaxa naslednji dan ob isti uri.
Pradaxa can be taken with or without food.
• Zdravilo Pradaxa lahko jemljete s hrano ali brez.
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).
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).
Paediatric population (DVT/PE)
Pediatrična populacija (GVT/PE)
Pradaxa contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants.
Pradaxa vsebuje učinkovino dabigatran eteksilat in spada v skupino zdravil, ki se imenujejo antikoagulanti.
The rates of outcome events including, major bleed and other bleeding events were consistent with those seen in RE-LY.
Stopnje opazovanih dogodkov, ki so zajemali velike in druge krvavitve, se niso razlikovale od njihovih ugotovljenih v študiji RE-LY.
For dose modifications in this population see table 1 above.
Za spremembe odmerkov pri tej skupini bolnikov glejte preglednico 1 zgoraj.
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).
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).
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.
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.
Concomitant administration is expected to result in decreased dabigatran concentrations.
Sočasna uporaba predvidoma zmanjša dabigatranovo koncentracijo.
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.
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.
Patients who develop acute renal failure must discontinue Pradaxa (see also section 4.3).
Bolniki, pri katerih se razvije akutna ledvična odpoved, morajo zdravilo Pradaxa prenehati jemati (glejte tudi poglavje 4.3).
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
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
• Inform your doctor about your intake of Pradaxa
• Obvestite svojega zdravnika o jemanju zdravila Pradaxa
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.
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.
Pradaxa 150 mg N (%)
Zdravilo Pradaxa 150 mg N (%)
Other medicines and Pradaxa
Druga zdravila in zdravilo Pradaxa
With improving monitoring of INR the observed benefits of dabigatran etexilate compared to warfarin diminish.
Z izboljšanim spremljanjem INR se koristi dabigatran eteksilata v primerjavi z varfarinom zmanjšajo.
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).
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).
• After removing the capsule, place the cap back on the bottle and tightly close the bottle right away after you take your dose.
• Ko ste kapsulo vzeli ven, namestite na plastenko pokrovček in jo takoj po jemanju odmerka tesno zaprite.
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.
Zdravilo Pradaxa je treba previdno uporabljati pri stanjih s povečanim tveganjem krvavitve ali sočasni uporabi zdravil, ki vplivajo na hemostazo z zaviranjem agregacije trombocitov.
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.
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).
Two randomized, parallel group, double-blind studies were performed in patients previously treated with anticoagulation therapy.
Opravljeni sta bili dve dvojno slepi študiji s paralelnimi skupinami naključno izbranih bolnikov, ki so predhodno že jemali antikoagulacijska zdravila.
Table 8: Adverse reactions SOC / Preferred term
Preglednica 8: Neželeni učinki Organski sistem / prednostno poimenovanje
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.
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.
Pradaxa should be temporarily discontinued.
Zdravilo Pradaxa je treba začasno ukiniti.
30 x 1 hard capsule
30 x 1 trda kapsula
Major bleeding occurred in 0.97 per 100 patient-years.
Velika krvavitev se je pojavila pri 0,97 na 100 bolnik-let.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Neklinični podatki na osnovi običajnih študij farmakologije varnosti, toksičnosti ponavljajočih odmerkov in genotoksičnosti ne kažejo posebnega tveganja za človeka.
Do not take Pradaxa
Ne jemljite zdravila Pradaxa
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.
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.
Coagulation tests may become unreliable following administration of suggested coagulation factor concentrates.
Po dajanju predlaganih koncentratov koagulacijskih faktorjev so lahko preskusi koagulacije nezanesljivi.
For dose modifications in this population see table 2 above.
Za spremembe odmerkov pri tej skupini bolnikov glejte preglednico 2 zgoraj.
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.
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.