natgillin/translations-raw huggingface dataset:
This is considered to be due to the carry-over effect of dabigatran treatment, however, this did not lead to a prolongation of bleeding time.
Menijo, da je tako zaradi učinka “carry-over” zdravljenja z dabigatranom, vendar to ni podaljšalo časa krvavitve.
• Unexplained tiredness
• nepojasnjeno utrujenost ali
Discontinue the VKA and start Roteas when the international normalised ratio (INR) is ≤ 2.5.
Ukinite VKA in začnite z zdravilom Roteas, ko bo mednarodno normalizirano razmerje (INR) ≤ 2,5.
Within renal function subgroups, results for the secondary efficacy endpoints were consistent with those for the primary endpoint.
Znotraj podskupin, določenih glede na ledvično funkcijo, so bili rezultati za sekundarne opazovane dogodke učinkovitosti skladni s tistimi za primarni opazovani dogodek.
• When an invasive procedure is required, Roteas should be stopped at least 24 hours beforehand,
• Če je potreben invaziven poseg, je treba prenehati z uporabo zdravila Roteas vsaj 24 ur pred njim,
Assessment of renal function: CrCL should be monitored at the beginning of the treatment in all patients and afterwards when clinically indicated (see section 4.2).
Ocena delovanja ledvic: CrCL je treba pri vseh bolnikih spremljati na začetku zdravljenja, nato pa skladno s kliničnimi indikacijami (glejte poglavje 4.2).
• Reduced number of platelets in your blood (which can affect clotting)
• zmanjšano število krvnih ploščic v krvi (kar lahko vpliva na strjevanje krvi),
HR (95% CI) All Bleeding n
HR (95 % CI) Vse krvavitve n
• Low body weight ≤ 60 kg
• majhna telesna masa ≤ 60 kg,
Renal clearance accounts for approximately 35% of the administered dose.
Ledvični očistek predstavlja približno 35 % danega odmerka.
Therefore, use of edoxaban is not recommended in these patients.
Zato uporaba edoksabana pri teh bolnikih ni priporočljiva.
The safety and efficacy of Roteas in children and adolescents less than 18 years of age have not been established.
Varnost in učinkovitost zdravila Roteas pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
When the effects of edoxaban on digoxin PK were also examined, the Cmax of digoxin increased by approximately 28% and AUC by 7%.
Ko so raziskovali tudi učinke edoksabana na FK digoksina, se je Cmax digoksina zvečala za približno 28 % in AUC za 7 %.
After 14 days it is recommended that Roteas is discontinued and the VKA continued to be titrated to achieve an INR between 2 and 3.
Po 14 dneh je priporočljivo zdravilo Roteas ukiniti in še naprej titrirati VKA, da se doseže INR med 2 in 3.
The signs, symptoms, and severity (including fatal outcome) will vary according to the location and degree or extent of the bleeding and/or anaemia (see section 4.9 Management of bleeding).
Znaki, simptomi in resnost (vključno s smrtnim izidom) so odvisni od mesta, stopnje ali obsežnosti krvavitve in/ali anemije (glejte poglavje 4.9 Ukrepi pri krvavitvah).
• Details of the population potentially at higher risk of bleeding
• podrobnosti populacije, ki je potencialno izpostavljena večjemu tveganju za krvavitev;
Therefore, edoxaban should only be used in patients with NVAF and high creatinine clearance after a careful evaluation of the individual thromboembolic and bleeding risk.
Zato se pri bolnikih z NVAF in visokim očistkom kreatinina sme uporabljati edoksaban le po skrbni individualni presoji tveganja za trombembolijo in krvavitev.
A specific antidote antagonising the pharmacodynamic effect of edoxaban is not available.
Specifičnega antidota, ki bi izničil farmakodinamične učinke edoksabana, ni na voljo.
A total of 2149 subjects were treated with either edoxaban (N = 1067) or enoxaparin/warfarin (N = 1082).
Skupno 2149 oseb je bilo zdravljenih z edoksabanom (N = 1067) ali enoksaparinom/varfarinom (N = 1082).
Edoxaban increases the risk of bleeding and can cause serious, potentially fatal bleeding.
Edoksaban zvečuje tveganje krvavitve in lahko povzroči resno krvavitev, ki je lahko smrtna.
• Bleeding from the mouth and/or throat
• krvavitev iz ust in/ali žrela,
Pharmacotherapeutic group: Other antithrombotic agents, ATC code: B01AF03
Farmakoterapevtska skupina: Drugi antitrombotiki, oznaka ATC: B01AF03.
Following the switch to edoxaban on Day 4 the PT was equivalent to Day 3 of rivaroxaban and apixaban.
Po prehodu na edoksaban 4. dne je bil PT enak kot 3. dne pri rivaroksabanu in apiksabanu.
• If you miss a dose, take it immediately and then continue the following day as normal - do not take double the prescribed dose in a single day.
• Če pozabite vzeti odmerek zdravila, ga takoj vzemite in naslednji dan nadaljujte kot ponavadi - v istem dnevu ne smete dvakrat vzeti predpisanega odmerka.
Edoxaban has three active metabolites, the predominant metabolite (M-4), formed by hydrolysis, is active and reaches less than 10% of the exposure of the parent compound in healthy subjects.
Edoksaban ima tri aktivne presnovke; prevladujoči presnovek (M-4), ki nastane s hidrolizo, je aktiven in pri zdravih osebah doseže manj kot 10 % izpostavljenosti izhodne spojine.
• Do not stop taking Roteas without consulting your doctor as this can increase your risk of developing a blood clot.
• Zdravila Roteas ne nehajte jemati, ne da bi se prej posvetovali z zdravnikom, saj lahko to zveča vaše tveganje za nastanek krvnega strdka.
It works by blocking the activity of factor Xa, which is an important component of blood clotting.
Zdravilo deluje tako, da zavira aktivnost faktorja Xa, ki je pomembnakomponenta strjevanja krvi.
Safety in patients with VTE (DVT and PE) in Hokusai-VTE
Varnost pri bolnikih z VTE (GVT in PE) v študiji Hokusai-VTE
Prior to initiating Roteas, liver function testing should be performed.
Pred uvajanjem zdravila Roteas je treba opraviti testiranje funkcije jeter.
• Dizziness or sudden headache
• omotičnost ali nenaden glavobol,
The European Medicines Agency has deferred the obligation to submit the results of studies with edoxaban in one or more subsets of the paediatric population in prevention of arterial thrombosis, treatment of thromboembolism and prevention of thromboembolism (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z edoksabanom za eno ali več podskupin pediatrične populacije za preprečevanje arterijske tromboze, zdravljenje trombembolije in preprečevanje trombembolije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The programme is also aimed at ensuring that the healthcare professionals who intend to prescribe Roteas are aware of the Patient alert card and that the card is to be given to and reviewed with all patients treated with Roteas.
Eden od ciljev programa je tudi zagotoviti, da bodo zdravstveni delavci, ki nameravajo predpisovati zdravilo Roteas, vedeli za kartico z opozorili za bolnika in da bodo vedeli, da morajo kartico dati vsakemu bolniku, ki se bo zdravil z zdravilom Roteas, in jo skupaj z njim pregledati.
In patients with renal impairment the metabolite profile changes and a higher quantity of active metabolites are formed.
Pri bolnikih z okvaro ledvic je presnovni profil spremenjen in nastaja večja količina aktivnih presnovkov.
- if you are allergic to edoxaban or any of the other ingredients of this medicine (listed in section 6) - if you are actively bleeding - if you have a disease or condition that increases the risk of serious bleeding
- če ste alergični naedoksabanali katero koli sestavino tega zdravila (navedeno v poglavju6), - če aktivno krvavite, - če imate bolezen ali stanje, ki poveča tveganje za hude krvavitve (n.pr.
ABOUT YOUR TREATMENT
INFORMACIJE O VAŠEM ZDRAVLJENJU
Edoxaban is metabolised via hydrolysis (mediated by carboxylesterase 1), conjugation or oxidation by CYP3A4/5 (< 10%).
Edoksaban se presnavlja s hidrolizo (ki jo katalizira karboksilesteraza 1), konjugacijo ali oksidacijo s CYP3A4/5 (< 10 %).
You should take the tablet immediately and then continue the following day with the once daily tablet as usual.
Vzemite tableto takoj in potem naslednjega dne nadaljujte z jemanjem tablete enkrat na dan kot navadno.
Cardioversion should be performed no later than 12 hours after the dose of Roteas on the day of the procedure.
Kardioverzijo je treba izvesti največ 12 ur po odmerku zdravila Roteas na dan posega.
• Guidance regarding surgery or invasive procedure, and temporary discontinuation
• smernice glede operacij ali invazivnih posegov in smernice za začasno ukinitev zdravila;
Several sub-groups of patients, as detailed below, are at increased risk of bleeding.
Pri številnih podskupinah bolnikov, ki so podrobno opredeljene v nadaljevanju, obstaja zvečano tveganje za krvavitve.
Table 10: Efficacy Results from the Hokusai-VTE Study - mITT population, overall study period Primary endpointa
Preglednica 10: Rezultati učinkovitosti iz študije Hokusai-VTE - populacija mITT, celotno obdobje študije
The majority of subjects in the edoxaban and warfarin groups had cardioversion performed (83.7% and 78.9%, respectively) or were auto-converted (6.6% and 8.6%, respectively).
Pri večini oseb v skupinah z edoksabanom in varfarinom je bila opravljena kardioverzija (83,7 % oziroma 78,9 %) ali pa je pri njih prišlo do samodejne konverzije (6,6 % oziroma 8,6 %).
• Blood in the urine
• kri v urinu,
TEE-guided (within 3 days of initiation) or conventional cardioversion (at least 21 days of pre-treatment) was employed.
Uporabljena je bila kardioverzija, vodena s TEE (v 3 dneh od uvedbe), ali konvencionalna kardioverzija (vsaj 21 dni predzdravljenja).
Edoxaban is absorbed with peak plasma concentrations within 1 - 2 hours.
Absorpcija Edoksaban se absorbira z najvišjimi plazemskimi koncentracijami v 1 - 2 urah.
Chronic use of NSAIDs with edoxaban is not recommended.
Kronične uporabe NSAID z edoksabanom ne priporočajo.
• medicines to prevent organ rejection after transplantation (e.g. ciclosporin)
• zdravila za preprečevanje zavrnitve organov po presaditvi (n.pr.
This medicine helps to prevent blood clots from forming.
To zdravilo pomaga preprečevati nastanek krvnih strdkov.
If any of the above apply to you, tell your doctor before taking Roteas, because the effect of Roteas may be reduced.
Če se karkoli od naštetega nanaša na vas, se posvetujte z zdravnikom, preden boste začeli jemati zdravilo Roteas, ker se učinek zdravila Roteas lahko zmanjša.
All ICHs reported on the Adjudicated Cerebrovascular and Non-Intracranial bleed eCRF forms confirmed by the adjudicators are included in ICH counts.
Vsi ICH-ji, o katerih so poročali na obrazcih potrjenih elektronskih obrazcev poročil o primerih (eCRF) cerebrovaskularnih in ne-intrakranialnih krvavitev, ki so jih potrjevalci potrdili, so zajeti v številu ICH.
In a population pharmacokinetic analysis of the ENGAGE AF-TIMI 48 study, peak and total exposure in Asian patients and non-Asian patients were comparable.
V analizi populacijske farmakokinetike v študiji ENGAGE AF-TIMI 48 sta bili največja in celotna izpostavljenost pri azijskih in neazijskih bolnikih primerljivi.
• Bleeding following an injury (puncture)
• krvavitev po poškodbi (vbodljaj),
a On-Treatment: Time from first dose of study drug to last dose plus 3 days.
a Med zdravljenjem: čas od prvega odmerka zdravila v kliničnem preskušanju do zadnjega odmerka plus 3 dnevi.
Edoxaban was excreted in the breast milk of lactating rats.
Edoksaban se je izločal v mleko doječih podgan.
Roteas is not recommended as an alternative to unfractionated heparin in patients with pulmonary embolism who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy since the safety and efficacy of edoxaban have not been established in these clinical situations.
Zdravilo Roteasni priporočeno kot alternativa nefrakcioniranemu heparinu pri bolnikih s pljučno embolijo, ki so hemodinamično nestabilni ali bodo morda prejeli trombolizo ali pljučno embolektomijo, saj varnost in učinkovitost edoksabana v teh kliničnih situacijah nista bili ugotovljeni.
Roteas can be taken with or without food (see section 5.2).
Zdravilo Roteas se lahko jemlje skupaj s hrano ali brez nje (glejte poglavje 5.2).
Parenteral anticoagulants
parenteralni antikoagulanti
The patient should not take double the prescribed dose on the same day to make up for a missed dose.
Bolnik naj ne vzame dvakratnega predpisanega odmerka istega dne, da bi nadomestil pozabljeni odmerek.
Healthcare professionals are asked to report any suspected adverse reactions.
Zdravstvene delavce naprošamo, da poročajo o katerem koli domnevnemneželenem učinku zdravila.
RISK OF BLEEDING
TVEGANJE ZA KRVAVITEV
Roteas has no or negligible influence on the ability to drive and use machines.
Zdravilo Roteas nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
It is recommended that during the first 14 days of concomitant therapy the INR is measured at least 3 times just prior to taking the daily dose of Roteas to minimise the influence of Roteas on INR measurements.
Prvih 14 dni sočasnega zdravljenja je priporočljivo meriti INR vsaj trikrat tik pred jemanjem dnevnega odmerka zdravila Roteas, da se vpliv zdravila Roteas na meritve INR kolikor mogoče zmanjša.
Roteas should be restarted after the surgical or other procedures as soon as adequate haemostasis has been established, noting that the time to onset of the edoxaban anticoagulant therapeutic effect is 1 - 2 hours.
Po kirurških ali drugih postopkih je treba zdravilo Roteasponovno uvesti takoj, ko se vzpostavi zadostna hemostaza, pri čemer upoštevajte, da je čas do nastopa antikoagulantnega terapevtskega učinka edoksabana 1 - 2 uri.
For transoesophageal echocardiogram (TEE) guided cardioversion in patients not previously treated with anticoagulants, Roteas treatment should be started at least 2 hours before cardioversion to ensure adequate anticoagulation (see sections 5.1 and 5.2).
Pri bolnikih, pri katerih se izvaja kardioverzija, vodena s transezofagealno ehokardiografijo (TEE), in ki niso bili predhodno zdravljeni z antikoagulanti, je treba zdravljenje z zdravilom Roteas začeti vsaj 2 uri pred kardioverzijo, da se zagotovi zadostna antikoagulacija (glejte poglavji 5.1 in 5.2).
HR (97.5% CI) p-value for non-inferiorityc
HR (97,5% CI) vrednost p za neinferiornostc
In deciding whether a procedure should be delayed until 24 hours after the last dose of Roteas, the increased risk of bleeding should be weighed against the urgency of the intervention.
Pri odločanju, ali naj se poseg odloži na čas, ko bo minilo 24 ur od zadnjega odmerka zdravila Roteas, je treba pretehtati zvečanje tveganja za krvavitve in nujnost posega.
- Film coat:
- Filmska obloga:
• Anaemia (low levels of red blood cells)
• anemija (slabokrvnost, pomanjkanje rdečih krvničk),
Thus, medicines or disease conditions that increase gastric emptying and gut motility have the possibility of reducing edoxaban dissolution and absorption.
Zato zdravila ali bolezenska stanja, ki pospešujejo praznjenje želodca in motiliteto črevesa, lahko zmanjšajo raztapljanje in absorpcijo edoksabana.
Vitamin K Antagonist (VKA)
Roteas antagonist vitamina K (VKA)
This method is recommended when assessing patients' CrCL prior to and during Roteas treatment.
Ta metoda je priporočena pri ocenjevanju CrCL bolnikov pred zdravljenjem z zdravilom Roteasin med njim.
• Contraindications
• kontraindikacije;
Concomitant Roteas and VKA can increase the INR post Roteas dose by up to 46%.
Sočasno dajanje zdravila Roteas in VKA lahko zveča INR po odmerku zdravila Roteas za do 46 %.
The active substance edoxaban tosilate is persistent in the environment (for instructions on disposal see section 6.6).
Zdravilna učinkovina edoksabanijev tozilat je v okolju dolgo obstojna (za navodila za odstranjevanje glejte poglavje 6.6).
The main analysis of efficacy was aimed to show the non-inferiority of edoxaban versus warfarin on first stroke or SEE that occurred during treatment or within 3 days from the last dose taken in the modified intention-to-treat (mITT) population.
Cilj glavne analize učinkovitosti je bil pokazati neinferiornost edoksabana v primerjavi z varfarinom za prvo možgansko kap ali SEE, ki je nastopil med zdravljenjem ali znotraj 3 dni od zadnjega odmerka, ki ga je vzel bolnik, v populaciji z modificiranim namenom zdravljenja (mITT).
• Please read the Patient Information Leaflet found inside each pack of Roteas.
• Preberite navodila za uporabo zdravila za bolnika, ki ga boste našli v vsakem pakiranju zdravila Roteas.
Like other similar medicines (medicines to reduce blood clotting), Roteas may cause bleeding which may potentially be life-threatening.
Kot druga podobna zdravila (zdravila, ki zmanjšujejo strjevanje krvi)lahko zdravilo Roteaspovzroči krvavitev, ki je lahko celo smrtno nevarna.
If you become pregnant while you are taking Roteas, immediately tell your doctor, who will decide how you should be treated.
zanosite, to nemudoma povejte svojemu zdravniku, ki bo odločil, kako vas bo treba zdraviti.
Roteas, like other anticoagulants, is recommended to be used with caution in patients with increased risk of bleeding.
Priporočljivo je, da se zdravilo Roteas, podobno kot drugi antikoagulanti, uporablja previdno pri bolnikih z zvečanim tveganjem za krvavitve.
The primary safety outcome was a composite of major and CRNM bleeding.
Primarni izid varnosti je bil kompozit velikih krvavitev in CRNM krvavitev.
Once a stable INR of ≥ 2.0 is achieved, the parenteral anticoagulant should be discontinued and the VKA continued.
Ko se doseže stabilen INR ≥ 2,0, parenteralni antikoagulant ukinite in nadaljujte z VKA.
Due to the pharmacological mode of action, the use of Roteas may be associated with an increased risk of occult or overt bleeding from any tissue or organ which may result in post haemorrhagic anaemia.
Zaradi farmakološkega načina delovanja lahko uporabo zdravila Roteas spremlja večje tveganje za prikrite ali očitne krvavitve iz tkiv ali organov, ki lahko povzročijo posthemoragično anemijo.
Data from animals indicate that edoxaban is secreted into breast milk.
Podatki z živali kažejo, da se edoksaban izloča v materino mleko.
In rats, no effects on male or female fertility were seen.
Pri podganah niso ugotovili nobenih učinkov na plodnost samcev ali samic.
(≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), not known (cannot be estimated from the available data).
zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 to < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
• Abnormal vaginal bleeding, including heavier or prolonged menses
• neobičajno krvavitev iz nožnice, vključno z močnejšo ali dlje trajajočo menstruacijo.
Cartons of 10, 14, 28, 30, 56, 60, 84, 90, 98, 100 film-coated tablets.
Kartonske škatle s po 10, 14, 28, 30, 56, 60, 84, 90, 98, 100 filmsko obloženimi tabletami.
Haemodialysis does not significantly contribute to edoxaban clearance (see section 5.2).
Hemodializa ne prispeva pomembno k očistku edoksabana (glejte poglavje 5.2).
This exploratory study showed low rates of major and CRNM bleeding and thromboembolism in the two treatment groups in the setting of cardioversion.
Ta raziskovalna študija je pokazala majhno pogostnost velikih krvavitev, CRNM krvavitev in trombembolije v obeh skupinah zdravljenja v kontekstu kardioverzije.
All subjects with symptomatic recurrent VTEc, n (%)
Vsi preiskovanci s simptomatskim recidivnim VTE,c n (%)
Haemodialysis A 4 hour haemodialysis session reduced total edoxaban exposures by less than 9%.
Hemodializa 4-urni postopek hemodialize je zmanjšal celotno izpostavljenost edoksabanu za manj kot 9 %.
• rifampicin, an antibiotic
• antibiotik rifampicin.
You have been prescribed Roteas, an anticoagulant medicine, which thins your blood and helps prevent you from suffering blood clots.
Predpisali so vam zdravilo Roteas, zdravilo proti strjevanju krvi, ki redči kri in vas pomaga zaščititi pred krvnimi strdki.
Patients with elevated liver enzymes (ALT/AST > 2 x ULN) or total bilirubin ≥ 1.5 x ULN were excluded in clinical trials.
Bolnike z zvišanimi jetrnimi encimi (ALT/AST >2 x ULN) ali s celotnim bilirubinom ≥1,5 x ULN so izključili iz kliničnih preskušanj.
• Roteas may increase the risk of bleeding.
• Zdravilo Roteas lahko zveča tveganje za krvavitev.
Haemodynamically unstable PE patients or patients who require thrombolysis or pulmonary embolectomy
Hemodinamično nestabilni bolniki s PE ali bolniki, ki potrebujejo trombolizo ali pljučno embolektomijo
• Necessity to carry the Patient alert card with them at all times
• o potrebi, da imajo kartico z opozorili za bolnika vedno s seboj;
PRESCRIBER INFORMATION For more information or in case of emergency, please contact: Physician's name:
Za več informacij ali v nujnem primeru se obrnite na:
Edoxaban produces rapid onset of pharmacodynamic effects within 1 - 2 hours, which corresponds with peak edoxaban exposure (Cmax).
Farmakodinamični učinki edoksabana nastopijo hitro, v 1 - 2 urah, kar ustreza največji izpostavljenosti edoksabanu (Cmax).
Inhibition of factor Xa in the coagulation cascade reduces thrombin generation, prolongs clotting time and reduces the risk of thrombus formation.
Inhibicija faktorja Xa v koagulacijski kaskadi zmanjša nastajanje trombina, podaljšuje čas strjevanja in zmanjšuje tveganje nastanka tromba.
Phone no:
Telefonska številka:
Depending on local availability, a consultation with a coagulation expert should be considered in case of major bleedings.
Odvisno od lokalne dostopnosti zdravniške službe je treba v primeru večjih krvavitev razmisliti o posvetu z zdravnikom, ki ima izkušnje z antikoagulantnim zdravljenjem.
• a problem with the blood vessels in the back of your eyes (retinopathy)
• problem s krvnimi žilami vašega očesnega ozadja(retinopatija),
Edoxaban decreased the Cmax and AUC of concomitantly administered verapamil by 14% and 16%, respectively.
Edoksaban je zmanjšal Cmax in AUC sočasno danega verapamila za 14 % oziroma 16 %.
This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.
To lahko vključuje aktivno ali nedavno razjedo v prebavilih, prisotno maligno neoplazmo z visokim tveganjem za krvavitve, nedavno poškodbo možganov ali hrbtenice, nedavni kirurški poseg na možganih, hrbtenici ali očeh, nedavno intrakranialno krvavitev, varice požiralnika ali sum nanje, arteriovenske nepravilnosti, žilne anevrizme ali velike intraspinalne ali intracerebralne žilne nepravilnosti.
For NVAF and VTE the recommended dose is 30 mg edoxaban once daily in patients with one or more of the following clinical factors:
Za NVAF in VTE je priporočeni odmerek 30 mg edoksabana enkrat na dan pri bolnikih z enim ali več od naslednjih kliničnih dejavnikov:
For dabigatran higher aPTT activity was observed after edoxaban administration with prior dabigatran treatment compared to that after treatment with edoxaban alone.
Pri dabigatranu so opazili večjo aktivnost aPTT po uporabi edoksabana s predhodnim zdravljenjem z dabigatranom kot po zdravljenju samo z edoksabanom.
In clinical studies, co-administration of NSAIDs resulted in increased clinically relevant bleeding.
V kliničnih študijah je sočasna uporaba NSAID zvečala klinično pomembno krvavitev.
Concomitant use of edoxaban with quinidine, verapamil, or amiodarone does not require dose reduction based on clinical data (see section 4.2).
Pri sočasni uporabi edoksabana s kinidinom, verapamilom ali amiodaronom zmanjšanje odmerka na podlagi kliničnih podatkov ni potrebno (glejte poglavje 4.2).
Patients with mild or moderate hepatic impairment exhibited comparable pharmacokinetics and pharmacodynamics to their matched healthy control group.
Bolniki z blago ali zmerno okvaro jeter so kazali farmakokinetiko in farmakodinamiko, ki sta bili primerljivi tistima pri njihovi zdravi kontrolni skupini z enakimi demografskimi podatki.