natgillin/translations-raw huggingface dataset:
When clinically relevant bleeding occurs, treatment should be interrupted. 
Če se pojavi klinično pomembna krvavitev, je treba zdravljenje prekiniti.
Mean on-therapy follow-up time was 18.3 months. 
Povprečen čas spremljanja z zdravljenjem je bil 18,3 meseca.
® TT (Anti-FIIa) 1.36 fold, respectively. 
® TT (anti-FIIa) 1,36-krat.
No rebound effect was observed. 
Povratnega učinka ni bilo.
Tables 20-22 display details of key results in the overall population: 
V preglednicah 20 do 22 so podrobno navedeni ključni podatki za vso populacijo:
The signs, symptoms, and severity (including fatal outcome) will vary according to the location and degree or extent of the bleeding and/or anaemia. 
Znaki, simptomi in resnost (vključno s smrtnim izidom) je odvisna od mesta in stopnje ali obsega krvavitve in/ali anemije.
The study included observational follow-up for 12 months after the conclusion of treatment. 
V študiji je po končanem zdravljenju sledilo 12-mesečno opazovalno obdobje.
Based on in vitro results a similar effect as with ketoconazole may be expected. 
Na podlagi rezultatov in vitro se lahko pričakuje podoben učinek kot pri ketokonazolu.
DVT/PE prevention (RE-MEDY, RESONATE) 
Preprečevanje GVT/PE (RE-MEDY, RESONATE)
Protease inhibitors such as ritonavir 
Zaviralci proteaze, kot je ritonavir
Duration of maintenance dose 
Trajanje vzdrževalnega odmerka
After multiple doses a terminal half-life of about 12-14 hours was observed. 
Po več odmerkih je bila končna razpolovna doba približno 12 do 14 ur.
All symptomatic treatment should be given according to the physician's judgement. 
Vse ukrepe simptomatičnega zdravljenja je treba uvajati po zdravnikovi presoji.
• Information on medicinal products that are contraindicated or which should be used with caution due to an increased risk of bleeding and/or increased dabigatran exposure 
• Podatke o zdravilih, ki so kontraindicirana oziroma jih je treba uporabljati previdno zaradi povečanega tveganja za krvavitve in/ali povečane izpostavljenosti dabigatranu
Cmax and AUC were dose proportional. 
Vrednosti Cmax in AUC sta bili sorazmerni z velikostjo odmerka.
In particular you should tell your doctor before taking Pradaxa, if you are taking one of the medicines listed below: 
Zdravnika morate pred jemanjem zdravila Pradaxa obvestiti zlasti, če jemljete eno od zdravil, navedenih spodaj:
Although high aPTT values should be interpreted with caution, a high aPTT value indicates that the patient is anticoagulated. 
Čeprav je treba visoke vrednosti aPTČ razlagati previdno, kaže visoka vrednost aPTČ pri bolniku na antikoagulacijo.
These affect P-gp (either as inhibitor or as inducer). 
Ta zdravila vplivajo na P-gp (kot zaviralci ali induktorji).
• Contraindication for patients with prosthetic heart valves requiring anticoagulant treatment 
• Kontraindikacijo za bolnike z umetnimi srčnimi zaklopkami, ki potrebujejo antikoagulantno zdravljenje
Additional requirements in patients with mild to moderate renal impairment and in patients aged over 75 years: 
Dodatne zahteve pri bolnikih z blago do zmerno ledvično okvaro in starejših od 75 let:
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 
Oneželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
For both surgery types, treatment should not be started if there is bleeding from the site of operation. 
Za obe vrsti operacij velja, da zdravljenja ne smete začeti, če na mestu operacije krvavite.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union references dates (EURD list) provided for under Artical 107c(7) of Directive 1002/83/EC and any subsequent updates published on the European medicines web-portal. 
• Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
The capsules can be taken with or without food. 
Kapsule je možno jemati s hrano ali brez hrane.
There are no clinical data of the effect of dabigatran on infants during breast-feeding. 
Ni kliničnih podatkov o vplivu dabigatrana na dojenčke med dojenjem.
The risk of spinal or epidural haematoma may be increased in cases of traumatic or repeated puncture and by the prolonged use of epidural catheters. 
Tveganje za spinalni ali epiduralni hematom je lahko povečano pri travmatski ali ponovljeni punkciji in daljši uporabi epiduralnih katetrov.
% refers to yearly event rate 
% pomeni letni odstotek dogodkov
Pradaxa should not be used during pregnancy unless clearly necessary. 
Zdravila Pradaxa ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
® before any surgery/invasive procedure. 
® pred vsakršnim kirurškim/invazivnim posegom.
- if you have had a heart attack or if you have been diagnosed with conditions that increase the risk to develop a heart attack. 
- če ste imeli srčni infarkt ali so vam postavili diagnozo bolezni, ki povečuje tveganje za pojav srčnega infarkta.
The safety of Pradaxa has been evaluated in ten phase III studies including 23,393 patients exposed to Pradaxa (see Table 10). 
Varnost zdravila Pradaxa je bila ocenjena v desetih študijah faze III, ki so vključevale 23.393 bolnikov, izpostavljenih zdravilu Pradaxa (glejte preglednico 10).
• Lesion or condition, if considered a significant risk factor for major bleeding. 
• poškodba ali bolezensko stanje, ki se smatra kot večji dejavnik tveganja za velike krvavitve.
Dabigatran etexilate is a substrate for the efflux transporter P-gp. 
Dabigatran eteksilat je substrat za efluksni transportni P-gp.
If possible, Pradaxa should be discontinued at least 24 hours before invasive or surgical procedures. 
Kadar je možno, je treba zdravilo Pradaxa ukiniti najmanj 24 ur pred invazivnim ali kirurškim posegom.
Due to the pharmacological mode of action, the use of Pradaxa may be associated with an increased risk of occult or overt bleeding from any tissue or organ. 
Zaradi farmakološkega načina delovanja je lahko uporaba zdravila Pradaxa povezana s povečanim tveganjem prikrite ali odkrite krvavitve iz katerega koli tkiva ali organa.
if you have had a serious injury (e.g. a bone fracture, head injury or any injury requiring surgical treatment). 
• če ste imeli hudo poškodbo (na primer zlom kosti, poškodbo glave ali kakršno koli poškodbo, zaradi katere je bila potrebna operacija);
Myocardial Infarction (MI) 
Miokardni infarkt (MI)
• Prosthetic heart valves requiring anticoagulant treatment (see section 5.1). 
• umetne srčne zaklopke, ki zahtevajo antikoagulantno zdravljenje (glejte poglavje 5.1).
For the indication DVT/PE, the safety and efficacy of Pradaxa in children from birth to less than 18 years of age have not yet been established. 
Pri indikaciji za GVT/PE varnost in učinkovitost zdravila Pradaxa pri otrocih od rojstva do nedopolnjenega 18. leta še nista raziskani.
Treatment initiation on the day of surgery 1-4 hours after completed surgery 
Začetek zdravljenja na dan operacije, 1-4 ure po opravljeni operaciji
Dabigatran prolongs the thrombin time (TT), ECT, and aPTT. 
Dabigatran podaljša trombinski čas (TT - thrombin time), EKT in aPTČ.
The patient population was 64 % male, 70 % Caucasian and 16 % Asian. 
Populacijo bolnikov je sestavljalo 64 % moških, 70 % belcev in 16 % bolnikov azijske rase.
In this situation Pradaxa and verapamil should be taken at the same time. 
V tem primeru je treba jemati Pradaxo in verapamil hkrati.
Maintenance dose starting on the first day after surgery 
Vzdrževalni odmerek, ki se začne prvi dan po operaciji
In these four phase III trials, 16,709 patients were exposed to Pradaxa (see Table 9). 
V teh štirih študijah faze III je bilo zdravilu Pradaxa izpostavljenih 16.709 bolnikov (glejte preglednico 9).
After an intravenous dose, the dabigatran-derived radioactivity was eliminated primarily in the urine (85 %). 
Po intravenskem odmerku se je radioaktivno označen dabigatran pretežno izločal s sečem (85 %).
• Active clinically significant bleeding 
• aktivna, klinično pomembna krvavitev
SSRIs, SNRIs SSRIs and SNRIs increased the risk of bleeding in RE-LY in all treatment groups, 
SSRI, SNRI SSRI in SNRI so povečali tveganje krvavitve pri vseh zdravljenih skupinah v študiji
Pradaxa can be given as soon as the INR is < 2.0. 
Zdravilo Pradaxa lahko uvedemo, kakor hitro je INR < 2,0.
Recovery of the total radioactivity ranged from 88-94 % of the administered dose by 168 hours post dose. 
Skupno se je 88 do 94 % radioaktivnega odmerka izločilo v 168 urah po odmerku.
This educational pack is aimed at increasing awareness about the potential risk of bleeding during treatment with Pradaxa and providing guidance on how to manage that risk. 
Namen izobraževalnega gradiva je povečanje ozaveščenosti o možnem tveganju krvavitev med zdravljenjem z zdravilom Pradaxa in posredovanju smernic o načinih obvladovanja tega tveganja.
• Whenever the risk management system is modified, especially as th result of new information being received that may lead to significant change to the benefit/risk profile or as the result. 
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
Patients with an increased bleeding risk (see sections 4.4, 4.5, 5.1 and 5.2) should be closely monitored clinically (looking for signs of bleeding or anaemia). 
Bolnike s povečanim tveganjem krvavitve (glejte poglavja 4.4, 4.5, 5.1 in 5.2) je treba natančno spremljati (da bi odkrili znake krvavitve ali anemije).
These observations in real-world settings are consistent with the established safety and efficacy profile for dabigatran etexilate in the RE-LY study in this indication. 
Ta opažanja v realnem življenju so skladna z ugotovljenim profilom varnosti in učinkovitosti za dabigatran eteksilat v študiji RE-LY pri tej indikaciji.
Do not break, chew, or empty the pellets from the capsule since this may increase the risk of bleeding. 
Kapsule ne žvečite, ne lomite, iz nje ne izpraznite zrnc, saj to lahko poveča tveganje za krvavitev.
Currently available data are described in section 4.8 and 5.1, but no recommendation on a posology can be made. 
Dosegljivi podatki so navedeni v poglavjih 4.8 in 5.1, vendar priporočil o odmerjanju še ni mogoče podati.
Therefore, the possibility of haemorrhage is to be considered in evaluating the condition in any anticoagulated patient. 
Zato je možnost krvavitve treba upoštevati pri ocenjevanju stanja pri katerem koli bolniku, ki se zdravi z antikoagulanti.
Although Pradaxa does not in general require routine anticoagulant monitoring, the measurement of dabigatran related anticoagulation may be helpful to detect excessive high exposure to dabigatran in the presence of additional risk factors. 
Čeprav pri uporabi zdravila Pradaxa na splošno ni potrebno rutinsko spremljati antikoagulacijo, je merjenje dabigatranovega antikoagulacijskega učinka lahko v pomoč pri odkrivanju prevelike izpostavljenosti dabigatranu, kadar so prisotni dodatni dejavniki tveganja.
In the pooled RE-COVER and RE-COVER II studies, a total of 5,153 patients were randomised and 5,107 were treated. 
V združenih študijah RE-COVER in RE-COVER II je bilo skupno naključno razvrščenih 5153 bolnikov, zdravljenih bolnikov pa 5107.
Since thrombin (serine protease) enables the conversion of fibrinogen into fibrin during the coagulation cascade, its inhibition prevents the development of thrombus. 
Ker omogoča trombin (serinska proteaza) med koagulacijsko kaskado pretvorbo fibrinogena v fibrin, njegovo zaviranje prepreči razvoj tromba.
This is explained by completed dabigatran absorption after 2 hours. 
To lahko pojasnimo z dokončano absorpcijo dabigatrana po 2 urah.
Dabigatran is eliminated primarily in the unchanged form in the urine, at a rate of approximately 100 mL/min corresponding to the glomerular filtration rate. 
Dabigatran se pretežno izloča v nespremenjeni obliki s sečem, in sicer s hitrostjo približno 100 ml/min, kar ustreza hitrosti glomerulne filtracije.
This is considered to be due to the carry-over effect of enoxaparin treatment, and regarded as not clinically relevant. 
Menijo, da je bila to posledica prenosa učinka zdravljenja z enoksaparinom, ki velja za klinično nepomembno.
• Other medicinal products which may impair haemostasis 
• druga zdravila, ki lahko povzročijo motnje hemostaze
Depending on local availability, a consultation of a coagulation expert should be considered in case of major bleedings. 
Glede na lokalne možnosti se je treba pri pojavu velike krvavitve posvetovati s specialistom za koagulacijo.
In view of the long half-life of amiodarone the potential for an interaction may exist for weeks after discontinuation of amiodarone (see sections 4.2 and 4.4). 
Zaradi amiodaronove dolge razpolovne dobe je interakcija možna še tedne po ukinitvi amiodarona (glejte poglavji 4.2 in 4.4).
• If you fall or injure yourself, especially if you hit your head, urgently seek medical advice. 
• Če padete ali se poškodujete, zlasti če se udarite v glavo, takoj poiščite medicinsko pomoč.
All patients underwent a Trans-oesophageal Echocardiography (TEE) prior to catheter ablation. 
Pri vseh bolnikih je bila pred katetrsko ablacijo opravljena transezofagealna ehokardiografija (TEE).
Short duration of therapy (at least 3 months) should be based on transient risk factors (e.g. recent surgery, trauma, immobilisation) and longer durations should be based on permanent risk factors or idiopathic DVT or PE. 
Kratkotrajno zdravljenje (najmanj 3 mesece) mora temeljiti na prehodnih dejavnikih tveganja (kot so nedavna operacija, poškodba, imobilizacija), dolgotrajnejše pa na trajnih dejavnikih tveganja ali idiopatični GVT ali PE.
• Recommendations for dose reduction in at risk populations 
• Priporočila o zmanjšanju odmerka pri populacijah s povečanim tveganjem
Studies in animals have shown reproductive toxicity (see section 5.3). 
Študije na živalih so pokazale toksične vplive na sposobnost razmnoževanja (glejte poglavje 5.3).
This has been confirmed by in vivo studies with healthy volunteers, who did not show any interaction between this treatment and the following active substances: atorvastatin (CYP3A4), digoxin (P-gp transporter interaction) and diclofenac (CYP2C9). 
To so potrdile študije in vivo pri zdravih prostovoljcih, pri katerih ni bilo nikakršnih interakcij zdravila z naslednjimi zdravilnimi učinkovinami: atorvastatinom (CYP3A4), digoksinom (interakcija s prenosnim P-gp) in diklofenakom (CYP2C9).
CrCL(mL/min) 30 ≤ and < 50 50 ≤ and < 80 
CrCl (ml/min) 30 ≤ in < 50 50 ≤ in < 80
A dose reduction is recommended as indicated in section 4.2. 
Priporočeno je zmanjšanje odmerka, kot je navedeno v poglavju 4.2.
Do not stop taking Pradaxa without talking to your doctor first, because the risk of developing a blood clot could be higher if you stop treatment too early. 
Ne prenehajte jemati zdravila Pradaxa, ne da bi se najprej posvetovali z zdravnikom, saj se lahko nevarnost pojava krvnega strdka poveča, če zdravljenje ustavite prezgodaj.
It is very important to take Pradaxa before and after the operation exactly at the times you have been told by your doctor. 
Zelo pomembno je, da zdravilo Pradaxa vzamete pred in po operaciji točno takrat, ko vam naroči zdravnik.
- if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed. 
- če veste, da imate bolezen, imenovano antifosfolipidni sindrom (bolezen imunskega sistema, zaradi katere imate povečano tveganje za nastanek krvnih strdkov), o tem obvestite zdravnika, ki bo presodil, ali je treba zdravljenje spremeniti.
Laboratory coagulation parameters 
Laboratorijski parametri za koagulacijo
Relative risk was highest in patients ≥ 75 years. 
Relativno tveganje je bilo največje pri bolnikih starih 75 let in več.
Assessment of renal function prior to and during Pradaxa treatment 
Ocena ledvičnega delovanja pred in med zdravljenjem z zdravilom Pradaxa
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/. 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu/
® is mainly eliminated by the kidneys; adequate diuresis must be maintained. 
® se izloča predvsem skozi ledvice; zagotovljena mora biti zadostna diureza.
Therefore, related medicinal product interactions are not expected with dabigatran. 
Zato tovrstnih interakcij z drugimi zdravili pri dabigatranu ne pričakujemo.
The MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authority prior to distribution of the educational pack. 
Imetnik dovoljenja za promet z zdravilom se mora s prisotnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnega gradiva ter o načrtu razdeljevanja, in sicer pred razdeljevanjem izobraževalnega gradiva.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 
• Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1;
• Recommendation for kidney function measurement 
• Priporočilo za merjenje ledvičnega delovanja
The efficacy and safety was investigated in two multi-center, randomised, double blind, parallelgroup, replicate studies RE-COVER and RE-COVER II. 
Učinkovitost in varnost so proučili v dveh multicentričnih, dvojno slepih, replikacijskih študijah s paralelnimi skupinami naključno izbranih bolnikov, RE-COVER in RE-COVER II.
A prospective, randomized, open-label, multicenter, exploratory study with blinded, centrally adjudicated endpoint evaluation (RE-CIRCUIT) was conducted in 704 patients who were under stable anticoagulant treatment. 
Prospektivna, randomizirana, odprta, multicentrična raziskovalna študija s slepo centralno oceno opazovanega dogodka (RE-CIRCUIT) je vključevala 704 bolnike, ki so prejemali stabilno antikoagulacijsko zdravljenje.
In the studied patient population of RE-MODEL and RE-NOVATE (5,539 patients treated), 51 % suffered from concomitant hypertension, 9 % from concomitant diabetes, 9 % from concomitant coronary artery disease and 20 % had a history of venous insufficiency. 
V populaciji bolnikov v študijah RE-MODEL in RE-NOVATE (5539 zdravljenih bolnikov) je imelo 51 % bolnikov sočasno hipertenzijo, 9 % sladkorno bolezen, 9 % koronarno arterijsko bolezen in 20 % vensko insufucienco v anamnezi.
Procedures such as spinal anaesthesia may require complete haemostatic function. 
Pri postopkih, kot je spinalna anestezija, je potrebna popolna hemostazna funkcija.
What Pradaxa is and what it is used for 
Kaj je zdravilo Pradaxa in za kaj ga uporabljamo
The median CrCL in the RE-MEDY and RE-SONATE studies were 99.0 mL/min and 99.7 mL/min, respectively. 
V študijah RE-MEDY in RE-SONATE sta bili mediani CrCl 99,0 ml/min oziroma 99,7 ml/min.
prevent blood clots in the brain (stroke) and other blood vessels in the body if you have a form of irregular heart rhythm called nonvalvular atrial fibrillation and at least one additional risk factor. 
- preprečevanje krvnih strdkov v možganih (kap) in drugih žilah v telesu, če imate obliko nepravilnega bitja srca, ki se imenuje atrijska fibrilacija in vsaj en dodaten dejavnik tveganja;
Dabigatran etexilate and dabigatran are not metabolised by the cytochrome P450 system and have no in vitro effects on human cytochrome P450 enzymes. 
Dabigatran eteksilat in dabigatran se ne presnavljata prek sistema citokroma P450 ter in vitro ne vplivata na encime človeškega citokroma P450.
Factors increasing dabigatran plasma levels 
Dejavniki, ki povečajo raven dabigatrana v plazmi
In such cases a coagulation test (see sections 4.4 and 5.1) may help to determine whether haemostasis is still impaired. 
V teh primerih lahko s koagulacijskim testom (glejte poglavji 4.4 in 5.1) preverimo, ali je hemostaza še neustrezna.
In actively controlled VTE prevention trials 6,684 patients were treated with 150 mg or 220 mg Pradaxa daily. 
V aktivno nadzorovanih preskušanjih zdravila pri preprečevanju VTE so 6684 bolnikov zdravili s 150 ali 220 mg zdravila Pradaxa na dan.
24 hours before 
24 ur pred
In a small number of volunteers with severe renal insufficiency (CrCL 10-30 mL/min), the exposure (AUC) to dabigatran was approximately 6 times higher and the half-life approximately 2 times longer than that observed in a population without renal insufficiency (see sections 4.2, 4.3 and 4.4). 
Pri majhnem številu prostovoljcev s hudo ledvično insuficienco (CrCl 10 do 30 ml/min) je bila izpostavljenost (AUC) dabigatranu približno 6-krat večja in njegova razpolovna doba približno 2-krat daljša kot v populaciji brez ledvične insuficience (glejte poglavja 4.2, 4.3 in 4.4).
If you experience any bleeding event that does not stop by itself or if you experience signs of excessive bleeding (exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling) consult your doctor immediately. 
Če boste imeli krvavitev, ki se ne bo zaustavila, ali znake prekomerne krvavitve (neobičajna oslabelost, utrujenost, bledica, omotica, glavobol ali nepojasnjeno otekanje) se nemudoma posvetujte s svojim zdravnikom.
Postoperative phase 
Pooperativno obdobje
The volume of distribution of dabigatran of 60-70 L exceeded the volume of total body water indicating moderate tissue distribution of dabigatran. 
Volumen porazdelitve dabigatrana, ki je 60 do 70 l, je bil večji od volumna skupne vode v telesu, kar kaže na zmerno porazdelitev dabigatrana v tkivih.
• Low body weight (< 50 kg) 
Manj pomembni: • majhna telesna masa (< 50 kg)
Use of fibrinolytic medicinal products for the treatment of acute ischemic stroke 
Uporaba fibrinolitičnih zdravil za zdravljenje akutne ishemične možganske kapi
Patients who receive concomitant verapamil*, amiodarone, quinidine 
Bolniki, ki sočasno prejemajo verapamil*, amiodaron, kinidin
The duration of treatment with fixed dose of dabigatran was 174.0 days without coagulation monitoring. 
Zdravljenje s fiksnim odmerkom dabigatrana brez spremljanja koagulacije je trajalo 174,0 dni.
The inducing effect was diminished resulting in dabigatran exposure close to the reference by day 7 after cessation of rifampicin treatment. 
Indukcijski učinek se je zmanjšal, kar je povzročilo, da se je izpostavljenost dabigatranu do 7. dne po ukinitvi rifampicina približala referenčni izpostavljenosti.
Close clinical surveillance 
Natančen kliničen nadzor
You should not take Pradaxa if you are pregnant unless your doctor advises you that it is safe to do so. 
Če ste noseči, zdravila Pradaxa ne smete jemati, razen če vam zdravnik pove, da je jemanje varno.
Do not use this medicine after the expiry date which is stated on the carton, blister or bottle after “EXP”. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, pretisnem omotu ali plastenki, poleg oznake “EXP”.
Pradaxa is for oral use. 
Zdravilo Pradaxa je za peroralno uporabo.
These patients require frequent observation for neurological signs and symptoms of spinal or epidural haematoma. 
Bolnike je treba pogosto spremljati, da bi odkrili nevrološke znake in simptome spinalnih ali epiduralnih hematomov.
After discontinuation of study medication the effect was maintained until the end of the follow-up, indicating that the initial treatment effect of dabigatran etexilate was sustained. 
Po ukinitvi preskušanega zdravila se je njegov učinek ohranil do konca opazovalnega obdobja, kar kaže, da je začetni učinek dabigatrana še trajal.