natgillin/translations-raw huggingface dataset:
There is some experimental evidence to support the role of these medicinal products in reversing the anticoagulant effect of dabigatran, but data on their usefulness in clinical settings and also on the possible risk of rebound thromboembolism is very limited.
Postoje određeni eksperimentalni dokazi koji idu u prilog ulozi ovih lijekova u vraćanju antikoagulacijskog učinka dabigatrana, ali podaci o njihovim pozitivnim učincima u kliničkom okruženju te također o mogućem riziku povratka (rebound) tromboembolije su vrlo ograničeni.
Do not break, chew, or empty the pellets from the capsule since this may increase the risk of bleeding.
Ne lomite, žvačite i ne praznite pelete iz kapsule jer može doći do povećanog rizika od krvarenja.
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.
Prospektivno, randomizirano, otvoreno, multicentrično, eksplorativno ispitivanje s centralno vođenom ocjenom ishoda na maskiran način (RE-CIRCUIT) provedeno je u 704 bolesnika koji su bili na stabilnom liječenju antikoagulansom.
The patient population was 64 % male, 70 % Caucasian and 16 % Asian.
Uzorak je sačinjavalo 64 % muškaraca, 70 % bijelaca i 16 % Azijaca.
Haemorrhagic complications may present as weakness, paleness, dizziness, headache or unexplained swelling, dyspnoea, and unexplained shock.
Hemoragijske komplikacije mogu se manifestirati kao slabost, bljedilo, omaglica, glavobolja ili neobjašnjeno oticanje, dispneja i neobjašnjeni šok.
Tables 20-22 display details of key results in the overall population:
Tablice 20-22 sažimaju ključne rezultate studije za ukupnu populaciju:
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).
DVT/PE Trajanje liječenja mora se prilagoditi individualnim potrebama nakon pažljive procjene koristi liječenja u odnosu na rizike od krvarenja (vidjeti dio 4.4).
It is recommended to continue with the remaining daily doses of Pradaxa at the same time of the next day.
Preporučuje se nastaviti s preostalim dnevnim dozama Pradaxe u isto vrijeme sljedećeg dana.
For dose modifications in this population see table 1 above.
Za prilagodbe doze u ovoj populaciji vidjeti tablicu 1 iznad.
Selective serotonin re-uptake inhibitors (SSRIs) or selective serotonin norepinephrine re-uptake inhibitors (SNRIs)
Selektivni inhibitori ponovne pohrane serotonina (SSRI-i) ili selektivni inhibitori ponovne pohrane serotonina i noradrenalina (SNRI-i)
Pradaxa contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants.
Pradaxa sadrži djelatnu tvar dabigatraneteksilat i pripada skupini lijekova koji se nazivaju antikoagulansi.
The relative risk of bleeding with dabigatran compared to warfarin increased with age.
Relativni rizik od krvarenja uz dabigatran u usporedbi s varfarinom se povećao s dobi.
Pre-dosing of the probe inducer rifampicin at a dose of 600 mg once daily for 7 days decreased total dabigatran peak and total exposure by 65.5 % and 67 %, respectively.
Prethodno doziranje induktora rifampicina u dozi od 600 mg jedanput dnevno u trajanju 7 dana, smanjilo je ukupnu vršnu i ukupnu izloženost dabigatranu za 65,5 % i 67 %.
Pantoprazole and other proton-pump inhibitors (PPI) were co-administered with Pradaxa in clinical trials, and concomitant PPI treatment did not appear to reduce the efficacy of Pradaxa.
Pantoprazol i drugi inhibitori protonske pumpe (PPI) bili su istodobno primjenjivani s Pradaxom u kliničkim ispitivanjima, a istodobno liječenje PPI-om nije smanjilo djelotvornost Pradaxe.
From 6 hours prior to the next scheduled dose on, the missed dose should be omitted.
Nakon 6 sati prije planirane sljedeće doze, propuštena doza se preskače.
Close clinical surveillance
Poman klinički nadzor
Treatment initiation on the day of surgery 1-4 hours after completed surgery
Početak liječenja na dan kirurškog zahvata 1-4 sata nakon završetka kirurškog zahvata
No dose adjustment is necessary (see section 5.2), but close clinical surveillance is recommended in patients with a body weight < 50 kg (see section 4.4).
Nije potrebna prilagodba doze (vidjeti dio 5.2), ali preporučuje se poman klinički nadzor nad bolesnicima s tjelesnom težinom < 50 kg (vidjeti dio 4.4).
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.
Rizik spinalnog ili epiduralnog hematoma može biti povećan u slučajevima traumatske ili ponovljene punkcije te produljenom primjenom epiduralnih katetera.
Continue with your remaining daily doses of Pradaxa at the same time of the next day.
Nastavite s preostalim dnevnim dozama Pradaxe u isto vrijeme sljedećeg dana.
Not known
Rijetko nije poznato
Active substance exposure in the primary VTE prevention studies was about 40 % to 50 % higher in female patients and no dose adjustment is recommended.
Izloženost djelatnoj tvari u ispitivanjima primarne prevencije VTE-a u ženskih bolesnica je oko 40 % do 50 % veće te se ne preporučuje prilagodba doze.
Pradaxa should be temporarily discontinued.
Primjenu Pradaxe potrebno je privremeno prekinuti.
In atrial fibrillation patients females had on average 30 % higher trough and post-dose concentrations.
Žene s fibrilacijom atrija imale su u prosjeku 30% više minimalne koncentracije kao i koncentracije nakon doziranja.
Concomitant use not recommended e.g. ritonavir and its combinations with other protease inhibitors
Istodobna primjena se ne preporučuje npr. ritonavir i njegove kombinacije s drugim inhibitorima proteaze
• Details of populations potentially at higher risk of bleeding
• Detalje o skupinama koje su pod potencijalno većim rizikom od krvarenja
• CrCL ≥ 50 mL/min, VKA should be started 3 days before discontinuing Pradaxa
• CrCL ≥ 50 mL/min, s primjenom VKA treba započeti 3 dana prije prekida Pradaxe
The mean CHADS2 and HAS-BLED scores were 1.9 and 1.2, respectively.
Srednja vrijednost CHADS2 i HAS-BLED skorova bila je 1,9 odnosno 1,2.
In patients at higher risk of bleeding or in major surgery where complete haemostasis may be required consider stopping Pradaxa 2-4 days before surgery.
U bolesnika s povećanim rizikom od krvarenja ili u slučaju velikog kirurškog zahvata u kojem može biti potrebna potpuna hemostaza, razmotrite prekid primjene Pradaxe 2 - 4 dana prije kirurškog zahvata.
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.
- sprječavanje krvnih ugrušaka u mozgu (moždanog udara) ili drugim krvnim žilama u tijelu ako imate jedan oblik nepravilnog srčanog ritma koji se naziva nevalvularna fibrilacija atrija i najmanje jedan dodatni čimbenik rizika.
Emergency surgery or urgent procedures
Hitni kirurški zahvati ili hitni postupci
Given the available clinical and kinetic data no adjustment is necessary (see section 5.2), but close clinical surveillance is recommended (see section 4.4).
Prema dostupnim kliničkim i kinetičkim podacima nema potrebe za prilagođavanjem doze (vidjeti dio 5.2), ali se preporučuje poman klinički nadzor (vidjeti dio 4.4).
The method to be used to estimate renal function (CrCL in mL/min) is the Cockcroft-Gault method.
Metoda koja se koristi za procjenu bubrežne funkcije (CrCL po mL/min) je Cockcroft-Gaultova metoda.
Talk to your doctor before taking Pradaxa.
Obratite se svom liječniku prije nego uzmete Pradaxu.
No treatment experience is available for this subpopulation of patients, and therefore the use of Pradaxa is not recommended in this population.
Ne postoji iskustvo za ovu podskupinu bolesnika, stoga se u ovoj skupini primjena Pradaxe ne preporučuje.
An unexplained fall in haemoglobin and/or haematocrit or blood pressure should lead to a search for a bleeding site.
Neobjašnjen pad hemoglobina i/ili hematokrita ili krvnog tlaka zahtijeva nalaženje mjesta krvarenja.
The majority (80.8 %) of the subjects were in the ≥ 50 kg and < 100 kg category with no clear difference detected (see sections 4.2 and 4.4).
Većina (80,8 %) ispitanika bila je u kategoriji ≥ 50 kg i < 100 kg bez jasno vidljivih razlika u pogledu koncentracija dabigatrana (vidjeti dijelove 4.2 i 4.4).
Thus, in addition to adequate clinical surveillance, laboratory testing of haemoglobin/haematocrit is of value to detect occult bleeding.
Stoga, uz odgovarajuće kliničko praćenje, korisno je i laboratorijsko određivanje hemoglobina/hematokrita za otkrivanje okultnog krvarenja.
The MAH shall also provide a patient alert card in each medication pack, the text of which is included in Annex III.
Nositelj odobrenja također mora opremiti svaki paket s Karticom s upozorenjima za bolesnika,čiji tekst je uključen u Dodatak III.
This is considered to be due to the carry-over effect of enoxaparin treatment, and regarded as not clinically relevant.
Smatra se da je to posljedica prenešenog učinka (carry-over effect) liječenja enoksaparinom te se ne smatra klinički relevantnim.
Dabigatran etexilate is a small molecule prodrug which does not exhibit any pharmacological activity.
Dabigatraneteksilat je mala molekula, predlijek, koji ne pokazuje nikakvu farmakološku aktivnost.
Patients were eligible for the RELY-ABLE trial if they had not permanently discontinued study medication at the time of their final RE-LY study visit.
Bolesnici su bili pogodni za ispitivanje RELY-ABLE ako nisu trajno prekinuli primjenu lijeka iz ispitivanja u trenutku zaključnog posjeta u sklopu ispitivanja RE-LY.
If the treatment cannot be started until the day after surgery, dosing should be started with 2 capsules once a day.
Ukoliko liječenje ne može započeti sve do dana nakon zahvata, doziranje treba započeti s 2 kapsule jedanput dnevno.
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).
Bolesnike s povećanim rizikom od krvarenja (vidjeti dijelove 4.4, 4.5, 5.1 i 5.2) valja pažljivo klinički pratiti (radi znakova krvarenja ili anemije).
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.
Bez obzira na terapiju, najviši apsolutni rizik od IM-a primijećen je u sljedećim podskupinama, sa sličnim relativnim rizikom: bolesnici s prethodnim IMom, bolesnici ≥ 65 godina s ili dijabetesom ili koronarnom arterijskom bolešću, bolesnici s ejekcijskom frakcijom lijevog ventrikula < 40 % i bolesnici s umjerenom renalnom disfunkcijom.
• Do not push the capsules through the blister foil.
• Ne gurajte kapsule kroz foliju blistera.
In vitro interaction studies did not show any inhibition or induction of the principal isoenzymes of cytochrome P450.
In vitro ispitivanja interakcija nisu pokazala inhibiciju ili indukciju osnovnih izoenzima citokroma P450.
The increase was statistically significant in this study (p=0.022).
U ovom ispitivanju povećanje je bilo statistički značajno (p =
24 hours before
24 sata prije
• Management of overdose situations
• Zbrinjavanje situacija predoziranja
Polypropylene bottle with a screw cap containing 60 hard capsules.
Polipropilenska boca s navojnim zatvaračem koja sadrži 60 tvrdih kapsula.
Indication for anticoagulation
Indikacija za antikoagulaciju
An increased risk was seen in the elderly (≥ 75 years) for the 150 mg twice daily dose regimen.
Povećan rizik bio je opažen u starijih osoba (≥75 godina) kod režima davanja doze od 150 mg dvaput dnevno.
Tell your doctor immediately, if you experience a serious allergic reaction which causes difficulty in breathing or dizziness.
Odmah obavijestite liječnika ako imate ozbiljnu alergijsku reakciju koja izaziva tegobe u disanju ili omaglicu.
With a loading dose of 300 mg or 600 mg clopidogrel, dabigatran AUCτ,ss and Cmax,ss were increased by about 30-40 % (see section 4.4) .
S udarnom dozom od 300 mg ili 600 mg klopidogrela, AUCτ,ss i Cmax,ss dabigatrana bili su povišeni za oko 30 - 40 % (vidjeti dio 4.4).
You may need to be checked by a doctor, as you may be at increased risk of bleeding.
Možda će Vas trebati pregledati liječnik, jer možete biti pod povećanim rizikom od krvarenja.
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.
RE-MEDY, varfarinom kontrolirano ispitivanje, je uključivalo bolesnike koji su se već liječili 3 do 12 mjeseci s potrebom daljnjeg antikoagulacijskog liječenja a RE-SONATE, placebom kontrolirano ispitivanje, je uključivalo bolesnike koji su se već liječili 6 do 18 mjeseci antagonistima vitamina K.
For dose modifications in this population see table 2 above.
Za prilagodbe doze u ovoj populaciji vidjeti tablicu 2 iznad.
The pharmacokinetics and pharmacodynamics of dabigatran etexilate administered twice daily for three consecutive days (total 6 doses) at the end of standard anticoagulant therapy were assessed in an open-label safety and tolerability study in 9 stable adolescents (12 to < 18 years).
Farmakokinetika i farmakodinamika dabigatraneteksilata primjenjivanog dvaput dnevno tri uzastopna dana (ukupno 6 doza) na kraju standardnog antikoagulacijskog liječenja ocjenjivane su u otvorenom ispitivanju sigurnosti i podnošljivosti na 9 stabilnih adolescenata (12 do < 18 godina).
LMWH The concomitant use of LMWHs, such as enoxaparin and dabigatran etexilate has not been specifically investigated.
LMWH Istodobna primjena niskomolekularnih heparina (LMWH), poput enoksaparina i dabigatraneteksilata nije specifično ispitivana.
Taking too much Pradaxa increases the risk of bleeding.
Uzimanje prevelike količine Pradaxe povećava rizik od krvarenja.
A coagulation test (see section 4.4) may help to identify patients with an increased bleeding risk caused by excessive dabigatran exposure.
Test koagulacije (vidjeti dio 4.4) može pomoći u prepoznavanju bolesnika s povećanim rizikom od krvarenja uzrokovanim prekomjernim izlaganjem dabigatranu.
Results of both studies showed that the antithrombotic effect of Pradaxa 220 mg and 150 mg were statistically non-inferior to that of enoxaparin on total VTE and all-cause mortality.
Rezultati oba ispitivanja pokazali su da antitrombotički učinci Pradaxe u dozi od 220 mg i 150 mg statistički nisu inferiorni učinku enoksaparina na ukupni VTE i smrtnost svih uzroka.
Dabigatran prolongs the thrombin time (TT), ECT, and aPTT.
Dabigatran produljuje trombinsko vrijeme (TV), ECT i aPTV.
Plasma concentrations of dabigatran showed a biexponential decline with a mean terminal half-life of 11 hours in healthy elderly subjects.
Koncentracije dabigatrana u plazmi pokazale su bieksponencijalno smanjenje, s prosječnim terminalnim poluvijekom od 11 sati u zdravih starijih osoba.
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).
AUCτ,ss i Cmax,ss dabigatrana su se povećali u prosjeku za 1,53 puta i 1,56 puta, uz istodobnu primjenu kinidina (vidjeti dijelove 4.2 i 4.4).
Do not break, chew, or empty the pellets from the capsule.
Nemojte lomiti ili žvakati kapsulu niti prazniti pelete iz kapsule.
Peel off the backing foil and remove the capsule.
Odvojite stražnju foliju te izvadite kapsulu.
In case of an overdose suspicion, coagulation tests can help to determine a bleeding risk (see sections 4.4 and 5.1).
U slučaju sumnje na predoziranje, testovi koagulacije mogu pomoći u određivanju rizika od krvarenja (vidjeti dijelove 4.4 i 5.1).
Minor:
Manji:
In the RE-LY study, a total of 18,113 patients were randomized, with a mean age of 71.5 years and a mean CHADS2 score of 2.1.
RE-LY studiji ukupno je randomizirano 18 113 bolesnika, prosječne dobi 71,5 godina, s prosječnim CHADS2 skorom 2,1.
Posaconazole Posaconazole also inhibits P-gp to some extent but has not been clinically studied.
Posakonazol također u određenoj mjeri inhibira P-gp, ali nije klinički ispitivan.
What you need to know before you take Pradaxa
Što morate znati prije nego počnete uzimati Pradaxu
• Strong P-gp inhibitors (see section 4.3 and
• snažni P-gp inhibitori (vidjeti dio 4.3 i
In the event of haemorrhagic complications, Pradaxa treatment must be discontinued and the source of bleeding investigated.
U slučaju hemoragičkih komplikacija, liječenje Pradaxom mora se prekinuti, a izvor krvarenja treba ispitati.
If not otherwise specifically described, close clinical surveillance (looking for signs of bleeding or anaemia) is required when dabigatran is co-administered with strong P-gp inhibitors.
Ako nije drugačije naznačeno, potreban je poman klinički nadzor (praćenje znakova krvarenja ili anemije) kada se dabigatran primjenjuje istodobno sa snažnim P-gp inhibitorima.
The median CrCL in the RE-COVER study was 100.4 mL/min.
Medijan CrCL u ispitivanju RE-COVER bio je 100,4 mL/min.
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).
Učinak dobi na izloženost dabigatranu potvrđen je u RE-LY studiji, s oko 31 % višim najnižim koncentracijama u bolesnika ≥ 75 godina i za oko 22 % nižim najnižim vrijednostima u bolesnika < 65 godina u usporedbi s bolesnicima u dobi između 65 i 75 godina (vidjeti dijelove 4.2 i 4.4).
Gastrointestinal ulcer, including oesophageal ulcer
Gastrointestinalni ulkus, uključujući ezofagealni ulkus rijetko
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).
Događaji krvarenja za oba liječenja se računaju od prvog unosa Pradaxe ili varfarina nakon prekida parenteralnog liječenja (razdoblje isključivo peroralnog liječenja).
All secondary and sensitivity analyses of the primary endpoint and all secondary endpoints showed superiority of dabigatran etexilate over placebo.
Sve sekundarne analize kao i analize osjetljivosti primarnog ishoda i svih sekundarnih ishoda pokazale su superiornost dabigatraneteksilata u odnosu na placebo.
• NSAID
• NSAIL
Pharmacotherapeutic group: antithrombotic agents, direct thrombin inhibitors, ATC code: B01AE07.
Farmakoterapijska skupina: antitrombotik, direktni inhibitori trombina, ATK oznaka: B01AE07.
Pradaxa treatment does not need to be interrupted (see section 5.1).
Liječenje Pradaxom ne mora se prekinuti (vidjeti dio 5.1).
• In case of major bleeding events, Pradaxa ® must be stopped immediately.
• U slučaju velikih krvarenja, primjena Pradaxe ® se mora odmah prekinuti.
Enrolled patients continued to receive the same double-blind dabigatran etexilate dose randomly allocated in RE-LY, for up to 43 months of follow up after RE-LY (total mean follow-up RE-LY + RELY-ABLE, 4.5 years).
Uključeni bolesnici nastavili su primati jednaku dvostruko slijepu dozu dabigatraneteksilata koja im je nasumično dodijeljena u ispitivanju RE-LY, u trajanju do 43 mjeseca razdoblja praćenja nakon ispitivanja RE-LY (ukupni prosjek razdoblja praćenja za RE-LY + RELY-ABLE; 4,5 godine).
A non-interventional study (GLORIA-AF) prospectively collected (in its second phase) safety and effectiveness data in newly diagnosed NVAF patients on dabigatran etexilate in a real-world setting.
Neintervencijsko ispitivanje (GLORIA-AF) prospektivno je prikupilo (u svojoj drugoj fazi) podatke o sigurnosti i učinkovitosti dabigatraneteksilata u stvarnoj primjeni u novodijagnosticiranih bolesnika s NVAF-om.
Interaction with P-gp inducers
Interakcije s P-gp induktorima
Clearance of dabigatran by haemodialysis was investigated in 7 patients with end-stage renal disease (ESRD) without atrial fibrillation.
Klirens dabigatrana hemodijalizom ispitivan je na 7 bolesnika u završnom stadiju bolesti bubrega (ESRD) bez fibrilacije atrija.
Patients who receive concomitant verapamil*, amiodarone, quinidine
Bolesnici koji istovremeno primaju verapamil*, amiodaron, kinidin
Excessive anticoagulation may require interruption of Pradaxa treatment.
Pretjerana antikoagulacija može zahtijevati prekid liječenja Pradaxom.
There were 5897 patients enrolled, representing 49 % of patients originally randomly assigned to receive dabigatran etexilate in RE-LY and 86 % of RELY-ABLE-eligible patients.
Uključeno je 5 897 bolesnika, koji su predstavljali 49 % bolesnika prvotno nasumično odabranih za primanje dabigatraneteksilata u ispitivanju RE-LY te 86 % bolesnika koji su bili pogodni za ispitivanje RELY-ABLE.
The aPTT test is widely available and provides an approximate indication of the anticoagulation intensity achieved with dabigatran.
aPTV test se uvelike koristi i daje približnu indikaciju antikoagulacijskog intenziteta koji se postiže uz dabigatran.
Elderly patients outside of the United States (≥80 years of age for all countries, ≥70 years of age for Japan) were randomly assigned to the dabigatran etexilate 110 mg dual-therapy group or the warfarin triple-therapy group.
Stariji bolesnici izvan Sjedinjenih Američkih Država (u dobi ≥80 godina za sve države, ≥70 godina za Japan) nasumično su bili dodijeljeni u skupinu koja je primala dvojnu terapiju dabigatraneteksilatom 110 mg ili skupinu koja je primala trojnu terapiju varfarinom.
Pantoprazole When Pradaxa was co-administered with pantoprazole, a decrease in the dabigatran AUC of approximately 30 % was observed.
Kada je Pradaxa primjenjivana istodobno s pantoprazolom, opaženo je smanjenje AUC-a dabigatrana za oko 30 %.
Pradaxa should be stopped before elective surgery High risk of bleeding or major surgery
Primjenu Pradaxe potrebno je prekinuti prije elektivnog kirurškog zahvata Visoki rizik od krvarenja ili veliki zahvat
Duration of dabigatran etexilate treatment ranged from 6 to 36 months (median 534.0 days).
Trajanje liječenja dabigatraneteksilatom variralo je od 6 do 36 mjeseci (medijan 534,0 dana).
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.
Za istodobnu primjenu dabigatraneteksilata s fiksnom kombinacijom P-gp inhibitora glekaprevir/pibrentasvir pokazano je da povećava izloženost dabigatranu i može povećati rizik od krvarenja.
Tables 23-25 display results of the primary efficacy and safety endpoint in relevant sub-populations:
Tablice 23-25 sažimaju rezultate s obzirom na primarne ishode djelotvornosti i sigurnosti u relevantnim podskupinama:
Procedures such as spinal anaesthesia may require complete haemostatic function.
Postupci poput spinalne anestezije mogu zahtijevati uspostavljanje potpune hemostatske funkcije.
Patients who develop acute renal failure must discontinue Pradaxa (see also section 4.3).
Bolesnici koji razviju akutno zatajenje bubrega moraju prekinuti liječenje Pradaxom (vidjeti također dio 4.3).
Tables 18-19 display results of the primary efficacy and safety endpoint in relevant sub-populations:
Tablice 18-19 sažimaju rezultate s obzirom na primarne ishode djelotvornosti i sigurnosti u relevantnim podskupinama:
Use of fibrinolytic medicinal products for the treatment of acute ischemic stroke
Primjena fibrinolitika u liječenju akutnog ishemijskog moždanog udara
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.
Kod DVT/PE, preporučena primjena Pradaxe 220 mg uzeta u obliku jedne kapsule od 110 mg dvaput dnevno zasniva se na farmakokinetičkim i farmakodinamičkim analizama te nije ispitivana u ovom kliničkom okruženju.
Management of bleeding complications
Zbrinjavanje komplikacija krvarenja