natgillin/translations-raw huggingface dataset:
No data are available, therefore it is not recommended to start the administration of Pradaxa before the next scheduled dose of the parenteral anticoagulant would have been due (see section 4.5).
3 O taki zamenjavi ni podatkov, zato ne priporočamo začetka dajanja zdravila Pradaxa pred naslednjim običajnim odmerkom parenteralnega antikoagulanta (glejte poglavje 4. 5).
Pradaxa should be swallowed as a whole with water, with or without food.
Zdravilo Pradaxa je treba pogoltniti celo, z vodo, s hrano ali brez hrane.
• Hypersensitivity to the active substance or to any of the excipients • Patients with severe renal impairment (CrCl < 30 ml/ min) • Active clinically significant bleeding • Organic lesion at risk of bleeding • Spontaneous or pharmacological impairment of haemostasis • Hepatic impairment or liver disease expected to have any impact on survival • Concomitant treatment with quinidine (see section 4.5)
• preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov, • bolniki s hudo ledvično okvaro (CrCl < 30 ml/ min), • aktivna, klinično pomembna krvavitev • organska poškodba, povezana s tveganjem krvavitve, • spontana ali z jemanjem zdravil povezana motnja hemostaze, • jetrna okvara ali jetrna bolezen, ki bi predvidoma lahko vplivala na preživetje • sočasno zdravljenje s kinidinom (glejte poglavje 4. 5).
Patients with elevated liver enzymes > 2 ULN were excluded in controlled clinical trials.
Bolnike s povečanimi jetrnimi encimi na > 2 ULN so izključili iz nadzorovanih kliničnih preskušanj.
Therefore the use of Pradaxa is not recommended in this population.
Zato uporabe zdravila Pradaxa za to skupino bolnikov ne priporočamo.
ALT should be measured as part of the standard pre- operative evaluation.
ALT je treba meriti v sklopu standardne predoperacijske obravnave.
Haemorrhagic risk:
Tveganje za krvavitve
Close clinical surveillance (looking for signs of bleeding or anaemia) is recommended throughout the treatment period, especially in the following situations that may increase the hemorrhagic risk: diseases associated with an increased risk of bleeding, such as congenital or acquired coagulation disorders, thrombocytopenia or functional platelet defects, active ulcerative gastrointestinal disease, recent biopsy or major trauma, recent intracranial haemorrhage or brain, spinal or ophthalmic surgery, bacterial endocarditis.
Natančen klinični nadzor (da bi odkrili znake krvavitve ali anemije) priporočamo ves čas zdravljenja, zlasti pa v naslednjih okoliščinah, ki lahko povečajo tveganje za krvavitve: pri boleznih, ki so povezane s povečanim tveganjem za krvavitve, na primer prirojene ali pridobljene motnje strjevanja krvi, trombocitopenija ali okvara delovanja trombocitov, aktivna razjeda v prebavilih, nedavna biopsija ali večja poškodba, nedavna krvavitev v možganih ali operacija na možganih, hrbtenici ali na očeh ter bakterijski endokarditis.
Patients with moderate renal impairment have an increased exposure to dabigatran.
Pri bolnikih z zmerno ledvično okvaro prihaja do povečane izpostavljenosti dabigatranu.
Limited data is available in patients < 50 kg and the elderly (see sections 4.2 and 5.2).
O bolnikih z manjšo telesno maso od 50 kg in starejših (glejte poglavji 4. 2 in 5. 2) je malo podatkov.
In these situations, Pradaxa should be used with caution and a close clinical surveillance (looking for signs of bleeding or anemia) is required throughout the treatment period (see section 4.2).
V takih primerih moramo zdravilo Pradaxa dajati previdno in bolnike skrbno klinično nadzorovati (pozorni motamo biti na klinične znake krvavitve ali anemije) skozi vse obdobje zdravljenja (glejte poglavje 4. 2).
When severe bleedings occur treatment must be discontinued and the source of bleeding investigated (see section 4.9).
Če se pojavi huda krvavitev, moramo zdravljenje ukiniti in preiskati njen izvor (glejte poglavje 4. 9).
Agents that may enhance the risk of haemorrhage should not be administered concomitantly or should be administered with caution with Pradaxa (see section 4.5).
Zdravil, ki lahko povečajo tveganje za krvavitve, ne smemo dajati hkrati z zdravilom Pradaxa ali jih moramo dajati previdno (glejte poglavje 4. 5).
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:
4 Spinal anaesthesia/ epidural anaesthesia/ lumbar puncture:
Spinalna anestezija/ epiduralna anestezija/ lumbalna punkcija
In patients undergoing major orthopaedic surgery, epidural or spinal haematomas that may result in long- term or permanent paralysis cannot be excluded with the concurrent use of dabigatran and spinal/ epidural anaesthesia or spinal puncture.
Pri bolnikih, ki so prestali večjo ortopedsko operacijo ob sočasni uporabi dabigatrana in spinalne ali epiduralne anestezije ali spinalne punkcije ne moremo izključiti epiduralnih ali spinalnih hematomov, ki lahko povzročijo dolgotrajno ali trajno paralizo.
The risk of these rare events may be higher with postoperative use of indwelling epidural catheters or the concomitant use of other medicinal products affecting haemostasis.
Tveganje teh dogodkov, ki so redki, je lahko večje, če po operaciji uporabljamo stalne epiduralne katetre ali sočasno uporabljamo druga zdravila, ki vplivajo na hemostazo.
Therefore the use of Pradaxa is not recommended in patients undergoing anaesthesia with post-operative indwelling epidural catheters.
4 Uporabe zdravila Pradaxa zato ne priporočamo pri bolnikih, ki prejmejo anestezijo s pooperativnimi stalnimi epiduralnimi katetri.
Administration of the first dose of Pradaxa should occur a minimum of two hours after the catheter is removed.
Prvi odmerek zdravila Pradaxa je treba dati najmanj dve uri po odstranitvi katetra.
These patients require frequent observation for neurological signs and symptoms.
Bolnike moramo pogosto opazovati, da bi odkrili morebitne nevrološke znake in simptome.
Hip fracture surgery:
Operacija kolčnega zloma:
Therefore treatment is not recommended.
O uporabi zdravila Pradaxa pri bolnikih z operacijo kolčnega zloma ni podatkov, zato zdravljenja ne priporočamo.
Colorants:
Barvila:
Pradaxa hard capsules contain the colorant sunset yellow (E110), which may cause allergic reactions.
Zdravilo Pradaxa trde kapsule vsebuje barvilo oranžno FCF (E110), ki lahko povzroči alergijske reakcije.
Anticoagulants and platelet aggregation agents:
Antikoagulanti in zaviralci agregacije trombocitov:
The following treatments are not recommended concomitantly with Pradaxa: unfractionated heparins and heparin derivatives, low molecular weight heparins (LMWH), fondaparinux, desirudin, thrombolytic agents, GPIIb/ IIIa receptor antagonists, clopidogrel, ticlopidine, dextran, sulfinpyrazone and vitamin K antagonists.
Sočasno z zdravilom Pradaxa ne priporočamo dajanja naslednjih zdravil: nefrakcioniranih heparinov in derivatov heparina, nizkomolekularnih heparinov, fondaparinuksa, desirudina, trombolitikov, antagonistov receptorjev GPIIb/ IIIa, klopidogrela, tiklopidina, dekstrana ter sulfinpirazona in angatonistov vitamina K.
It should be noted that unfractionated heparin can be administered at doses necessary to maintain a patent central venous or arterial catheter (see sections 4.2 and 4.4).
Nefrakcionirani heparin smemo dajati v odmerkih, ki so potrebni za vzdrževanje prehodnosti centralnega venskega ali arterijskega katetra (glej poglavji 4. 2 in 4. 4).
Interactions linked to dabigatran etexilate and dabigatran metabolic profile:
Interakcije, povezane z dabigatran eteksilatom in presnovnimi lastnostmi dabigatrana:
NSAIDs:
Nesteroidna protivnetna zdravila:
When Pradaxa was coadministered with diclofenac, the plasma exposure of both medicinal products remained unchanged indicating a lack of a pharmacokinetic interaction between dabigatran etexilate and diclofenac.
Pri sočasnem dajanju zdravila Pradaxa in diklofenaka, se količina obeh zdravil v plazmi ni spremenila, kar kaže, da med dabigatran eteksilatom in diklofenakom ni farmakokinetične interakcije.
However, due to the risk of haemorrhage, notably with NSAIDs with elimination half-lives > 12 hours, close observation for signs of bleeding is recommended (see section 4.4).
Toda zaradi tveganja krvitev priporočamo zlasti pri hkratnem dajanju z nesteroidnimi protivnetnimi zdravili, katerih razpolovna doba izločanja je daljša od 12 ur, natančen nadzor bolnika zaradi znakov krvavitve (glejte poglavje 4. 4).
Transporter interactions:
S prenosom povezane interakcije
Amiodarone is an inhibitor of the efflux transporter P-glycoprotein and dabigatran etexilate a substrate of this transporter.
Amiodaron: je zaviralec efluksnega transportnega P- glikoproteina, dabigatran eteksilat pa njegov substrat.
When Pradaxa was coadministered with amiodarone, the extent and rate of absorption of amiodarone and its active metabolite DEA were essentially unchanged.
Pri sočasni uporabi zdravila Pradaxa in amiodarona se obseg in hitrost absorpcije amiodarona in njegovega aktivnega presnovka DEA nista bistveno spremenila.
The dabigatran AUC and Cmax were increased by about 60% and 50%, respectively.
AUC dabigatrana se je povečala za približno 60% Cmax pa za približno 50%.
In view of the long half-life of amiodarone the potential for drug interaction may exist for weeks after discontinuation of amiodarone.
Zaradi amiodaronove dolge razpolovne dobe je interakcija možna še tedne po ukinitvi amiodarona.
5 Dosing should be reduced to 150 mg Pradaxa daily in patients who received concomitantly dabigatran etexilate and amiodarone (see section 4.2).
Bolnikom, ki so hkrati prejemali dabigatran eteksilat in amiodaron, je treba odmerek zdravila Pradaxa zmanjšati na 150 mg na dan (glejte poglavje 4. 2).
P- glycoprotein inhibitors:
Zaviralci P- glikoproteina:
Caution should be exercised with strong P- glycoprotein inhibitors like verapamil, clarithromycin, and others.
Previdnost je potrebna pri močnih zaviralcih P- glikoproteina, kot so verapamil, klaritromicin in ostali.
The P- glycoprotein inhibitor quinidine is contraindicated (see section 4.3).
Zaviralec P- glikoproteina kinidin je kontraindiciran (glejte poglevje 4. 3).
P- glycoprotein inducers:
5 Induktorji P- glikoproteina:
Potent P- glycoprotein inducers such as rifampicin or St John’ s wort (Hypericum perforatum), may reduce the systemic exposure of dabigatran.
Močni induktorji P- glikoproteina, kot sta rifampicin ali šentjanževka (Hypericum perforatum), lahko zmanjšajo sistemsko izpostavljenost dabigatranu.
Caution is advised when co-administering these medicinal products.
Pri sočasni uporabi teh zdravil moramo biti previdni.
In a study performed with 24 healthy subjects, when Pradaxa was coadministered with digoxin, no changes on digoxin and no clinical relevant changes on dabigatran exposure have been observed.
V študiji pri 24 zdravih osebah, v kateri so zdravilo Pradaxa dajali sočasno z digoksinom, niso zasledili spremenjene izpostavljenosti digoksinu ali klinično pomembno spremenjene izpostavljenosti dabigatranu.
Gastric pH:
Želodčni pH
When Pradaxa was coadministered with pantoprazole, a decrease in the dabigatran area under the plasma concentration - time curve of approximately 30% was observed.
Pri sočasnem dajanju zdravila Pradaxa in pantoprazola se je za približno 30% zmanjšalo območje pod krivuljo plazemske koncentracije dabigatrana v odvisnosti od časa.
Pantoprazole and other proton- pump inhibitors were co-administered with Pradaxa in clinical trials and no effects on bleeding or efficacy were observed.
Ko so pantoprazol in druge zaviralce protonske črpalke v kliničnih preskušanjih dajali sočasno z zdravilom Pradaxa, niso zasledili vplivov na krvavitve ali učinkovitost zdravljenja.
Ranitidine administration together with Pradaxa had no clinically relevant effect on the extent of absorption of dabigatran.
Sočasno dajanje ranitidina in zdravila Pradaxa ni klinično pomembno vplivalo na obseg absorpcije dabigatrana.
There are no adequate data from the use of Pradaxa in pregnant women.
Ni zadostnih podatkov o uporabi zdravila Pradaxa pri nosečnicah.
Studies in animals have shown reproductive toxicity (see section 5.3).
Raziskave pri živalih so pokazale toksične učinke na razmnoževanje (glejte poglavje 5. 3).
Women of child-bearing potential should avoid pregnancy during treatment with dabigatran etexilate.
Ženske v rodni dobi se morajo med zdravljenjem z dabigatran eteksilatom izogibati nosečnosti.
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.
Lactation should be discontinued during treatment with Pradaxa.
Med zdravljenjem z zdravilom Pradaxa mora ženska prenehati dojiti.
A total of 10.084 patients were treated in 4 actively controlled VTE prevention trials with at least one dose of the medicinal product.
V štirih aktivno nadzorovanih preskušanjih zdravila pri preprečevanju VTE je sodelovalo 10. 084 bolnikov, ki so prejeli najmanj en odmerek zdravila.
Of these 5419 were treated with 150 mg or 220 mg daily of Pradaxa, while 389 received doses less than 150 mg daily and 1168 received doses in excess of 220 mg daily.
Od teh so jih 5419 zdravili s 150 ali 220 mg zdravila Pradaxa na dan, 389 jih je jemalo manjše odmerke od 150 mg na dan, 1168 pa večje odmerke od 220 mg na dan.
The most commonly reported adverse reactions are bleedings occurring in total in approximately 14% of patients; the frequency of major bleeds (including wound site bleedings) is less than 2%.
Pogostnost večjih krvavitev (tudi krvavitev iz rane) je manjša od 2%.
6 The table 1 shows the number (%) of patients experiencing bleeding events during the treatment period in the VTE prevention in the two pivotal clinical trials, according to dose.
V preglednici 1 je navedeno število (%) bolnikov, ki so imeli v dveh ključnih kliničnih raziskavah preprečevanja VTE med zdravljenjem dogodke s krvavitvijo.
Table 1 Bleeding events broken down to major and any bleeding in the pivotal hip and knee study
Odstotek večjih dogodkov s krvavitvijo in skupen odstotek dogodkov s krvavitvijo v ključni raziskavi kolena in kolka
Dabigatran etexilate 220 mg
Dabigatran eteksilat Dabigatran eteksilat 150 mg 220 mg
N (%)
Zdravljeni
Treated Major Bleeding Any bleeding
6 Večja krvavitev
1866(100.0) 24 (1.3) 258(13.8)
24 (1, 3)
1825(100.0) 33 (1.8) 251(13.8)
33 (1, 8)
1848(100.0) 27 (1.5) 247(13.4)
27 (1, 5)
Table 2 shows the adverse reactions ranked under headings of SOC and frequency using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000).
V preglednici 2 so navedeni neželeni učinki po organskih sistemih in pogostnosti: zelo pogosti (≥1/ 10), pogosti (≥1/ 100, < 1/ 10), občasni (≥ 1/ 1. 000, < 1/ 100), redki (≥1/ 10. 000, < 1/ 1. 000), zelo redki (< 1/ 10. 000).
SOC / Preferred Term.
prednostno poimenovanje
Dabigatran etexilate 150 mg
150 mg N (%)
Dabigatran etexilate 220 mg
220 mg N (%)
N (%)
Število bolnikov
Number of patients treated
zdravljenih
2737(100)
2737 (100)
Blood and lymphatic system disorders Common
Bolezni krvi in limfatičnega sistema pogosto anemija
Uncommon
občasno trombocitopenija Žilne bolezni
Thrombocytopenia
pogosto
5 (0.2)
(0. 2)
2 (0.1)
2 (0. 1)
5 (0.2)
5 (0. 2)
Vascular disorders Common
hematom travmatski hematom krvavitev rane
Uncommon
občasno krvavitev
Respiratory and thoracic system disorders Uncommon
Bolezni dihal, prsnega koša in mediastinalnega prostora občasno epistaksa Bolezni prebavil
Epistaxis
pogosto
Gastrointestinal disorders Common
krvavitev iz prebavil
Gastrointestinal haemorrhage
občasno
Uncommon
krvavitev in zadnjika krvavitev iz hemoroidov
Rectal haemorrhage
12 (0, 4) 4 (0, 2)
Alaninine aminotransferase increased
Bolezni jeter, žolčnika in žolčevodov občasno povečana alanin - aminotransferaza
Aspartate aminotransferase increased
povečana aspartat - aminotransferaza
Hepatic function abnormal/ Liver function Test
nenormalno jetrno delovanje / nenormalen izvid preiskave jetrnega delovanja
Dabigatran etexilate 220 mg
povečani jetrni encimi Hiperbilirubinemija povečane transaminaze Bolezni kože in podkožja
N (%)
pogosto
4 (0.2) 4 (0.1) 0 (0.0)
4 (0, 2) 4 (0, 1) 0 (0, 0)
Skin haemorrhage
krvavitev v koži
Musculoskeletal and connective tissue and bone disorders Uncommon
Bolezni mišično- skeletnega sistema in vezivnega tkiva občasno Hemartroza
Renal and urinary disorders Common
7 Bolezni sečil pogosto
General disorders and administration site conditions Uncommon
Splošne težave in spremembe na mestu aplikacije občasno krvavitev iz mesta vboda krvav izcedek krvavitev iz mesta vstavitve katetra Preiskave
Injection site haemorrhage Bloody discharge Catheter site haemorrhage
pogosto
Investigations Common
zmanjšanje hemoglobina
Haemoglobin decreased
občasno
Injury, poisoning and procedural complications Common
6 (0, 2)
Wound secretion Anaemia postoperative Post procedural haematoma Post procedural haemorrhage
4 (0, 1)
130 (4.8) 99 (3.6) 66 (2.4) 37 (1.4)
Poškodbe, zastrupitve in zapleti pri posegih pogosto
130 87 45 54
izcedek iz rane
(4.9) (3.2) (1.7) (2.0)
130 (4, 8)
93 120 78 56
130 (4, 9)
(3.0) (3.7) (2.5) (1.8)
93 (3, 0)
Post procedural discharge
anemija po operaciji hematom po postopku krvavitev po postopku izcedek po postopku Kirurški in drugi medicinski posegi občasno
31 (1.1)
99 (3, 6) 66 (2, 4) 37 (1, 4) 31 (1, 1)
34 (1.3)
87 (3, 2) 45 (1, 7) 54 (2, 0) 34 (1, 3)
31 (1.0)
120 (3, 7) 78 (2, 5) 56 (1, 8) 31 (1, 0)
Post procedural drainage Wound drainage
drenaža po postopku drenaža rane
11 (0.4) 1 (0.0)
11 (0. 4) 1 (0. 0)
13 (0.5) 4 (0.2)
13 (0. 5) 4 (0. 2)
16 (0.5) 2 (0.1)
16 (0. 5) 2 (0. 1)
Beyond the reported ALT findings the following laboratory chemistry data had been measured in phase 3 studies as presented in table 3.
Poleg navedenih izvidov za ALT so v študijah 3. faze izmerili še laboratorijske kemične vrednosti, ki jih prikazuje preglednica 3.
ALT findings the following laboratory chemistry
Izvidi za ALT
Dabigatran etexilate 150 mg
povečanje alanin -
Dabigatran etexilate 220 mg
Dabigatran eteksilat Dabigatran eteksilat 150 mg 220 mg N (%) N (%)
N (%)
enoksaparin N (%)
Total rates of Alaninine aminotransferase increased 3 x ULN
aminotransferaze na 3- krat ULN (zgornjo normalno mejo)
58 (2.2)
58 (2, 2) 68 (2, 5)
8 4.9 Overdose
4. 9 Preveliko odmerjanje
There is no antidote to dabigatran.
Za dabigatran ni antidota.
The initiation of appropriate treatment, e. g. surgical haemostasis or the transfusion of fresh frozen plasma should be considered.
Presoditi je treba o uvedbi ustreznega zdravljenja, na primer kirurški hemostazi ali transfuziji sveže zamrznjene plazme.
Dabigatran can be dialysed; there is no clinical experience to demonstrate the utility of this approach in clinical studies.
Dabigatran je mogoče dializirati, o čemer pa ni kliničnih izkušenj, ki bi kazale na tovrstno uporabnost v kliničnih študijah.
Pharmacotherapeutic group: direct thrombine inhibitors, ATC code:
8 Farmakoterapevtska skupina: direktni zaviralci trombina, oznaka ATC:
After oral administration, dabigatran etexilate is rapidly absorbed and converted to dabigatran by esterase- catalysed hydrolysis in plasma and in the liver.
Po peroralnem jemanju se hitro absorbira in pretvori v dabigatran s hidrolizo v plazmi in jetrih, ki jo katalizira esteraza.
Dabigatran also inhibits free thrombin, fibrin- bound thrombin and thrombin-induced platelet aggregation.
Dabigatran poleg tega zavira tudi prosti trombin, na fibrin vezani trombin in agregacijo trombocitov, ki jo povzroča trombin.
Steady state (after day 3) dabigatran peak plasma concentration, measured 2 - 4 hours after 220 mg dabigatran etexilate administration, is expected to be around 270 ng/ ml, with an expected range of 80 - 460 ng/ ml.
Pričakovana največje koncentracije dabigatrana v plazmi v stanju dinamičnega ravnovesja (po 3. dnevu), izmerjene 2 do 4 ure po dajanju 220 mg dabigatran eteksilata, so približno 270 ng/ ml, predvidoma v razponu od 80 do 460 ng/ ml.
The dabigatran trough concentration, measured at the end of the dosing interval (24 hours after the last 220 mg dabigatran dose), is expected to be around 40 ng/ ml, with expected range of 10-90 ng/ ml.
Pričakovana najmanjša dabigatranova koncentracija, izmerjena ob koncu odmernega intervala (24 ur po dajanju zadnjega 220 mg odmerka dabigatrana), je približno 40 ng/ ml, predvidoma v razponu 10 do 90 ng/ ml.
Ethnic origin:
Etnična pripadnost:
More than 99% of efficacy and safety data were generated in Caucasians.
Več kot 99% podatkov o učinkovitosti in varnosti je pridobljenih pri belcih.
Clinical trials in Venous Thromboembolism (VTE) prophylaxis following major joint replacement surgery:
Klinična preskušanja pri profilaksi venske trombembolije (VTE) po operativni vstavitvi večjega umetnega sklepa
In 2 large randomized, parallel group, double-blind, dose– confirmatory trials, patients undergoing elective major orthopaedic surgery (one for knee replacement surgery and one for hip replacement surgery) received Pradaxa 75 mg or 110 mg within 1-4 hours of surgery followed by 150 mg or 220 mg daily thereafter, haemostasis having been secured, or enoxaparin 40 mg on the day prior to surgery and daily thereafter.
V dveh velikih, randomiziranih, dvojno slepih preskušanjih za potrditev odmerka z vzporednima skupinama so bolniki po večji ortopedski operaciji (v prvem preskušanju po vstavitvi umetnega kolena in v drugem umetnega kolka) prejeli zdravilo Pradaxa po 75 mg ali 110 mg 1 do 4 ure po posegu in nato 150 mg ali 220 mg na dan ob zagotovljeni hemostazi, ali enoksaparin po 40 mg dan pred operacijo in nato vsak dan po njej.
In the RE-MODEL trial (knee replacement) treatment was for 6 – 10 days and in the RE-NOVATE trial (hip replacement) for 28 – 35 days.
V preskušanju RE- MODEL (vstavitev umetnega kolena) je zdravljenje trajalo 6 do 10 dni, v preskušanju RE- NOVATE (vstavitev umetnega kolka) pa 28 do 35 dni.
Totals of 2076 patients (knee) and 3494 (hip) were treated respectively.
Skupno število zdravljenih bolnikov je bilo 2076 (koleno) oziroma 3494 (kolk).
9 Composite of major VTE (including PE and proximal DVT, whatever symptomatic or asymptomatic detected by routine venography) and VTE-related mortality constituted a secondary end-point and is considered of better clinical relevance.
Sekundarni opazovani dogodek, ki velja za klinično pomembnejšega, je bil sestavljeni opazovani dogodek, in sicer venski trombembolični dogodek (tudi pljučna embolija in proksimalna globoka venska tromboza, simptomatska ali nesimptomatska, odkrita med rutinsko venografijo) in umrljivost povezana z venskim trombemboličnim dogodkom.
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.
Izsledki obeh raziskav so pokazali, da antitrombotični učinek zdraviala Pradaxa v odmerku 220 mg in 150 mg ni statistično manjši od učinka enoksaparina, če upoštevamo skupno pojavnost trombemboličnih dogodkov in umrljivost iz vseh vzrokov.
The point estimate for incidence of Major VTE and VTE related mortality for the 150 mg dose was slightly worse than enoxaparin (table 4).
Točkovna ocena pogostnosti večjih trombemboličnih dogodkov in umrljivosti v povezavi s trombemboličnim dogodkom je bila za odmerek 150 mg nekoliko slabša kot pri enoksaparinu (preglednica 4).
Better results were seen with the 220mg dose where the point estimate of Major VTE was slightly better than enoxaparin (table 4). "
Pri odmerku 220 mg so bili izidi boljši, saj je bila točkovna ocena za večje trombembolične dogodke nekoliko boljša kot pri enoksaparinu (preglednica 4).
There were no differences in the phase 3 clinical studies for efficacy and safety data between men and women.
9 V kliničnih raziskavah 3. faze se podatki o učinkovitosti in varnosti pri moških in ženskah niso razlikovali.